Archive

2013

Sysmex Inostics and Bayer HealthCare collaborate to develop blood-based companion diagnostic tests for targeted tumor therapies

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces that a collaboration agreement between Sysmex Inostics, a subsidiary of Sysmex Corporation, and Bayer HealthCare has been concluded as outlined below.

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced a master collaboration agreement with Bayer HealthCare for the development of companion diagnostics for targeted cancer therapies. The partnership pairs Sysmex Inostics’ innovative blood-based companion diagnostic solutions with targeted anti-cancer agents developed by Bayer.

“We are pleased to partner with Bayer HealthCare, a global company with an extensive drug development expertise and a broadening oncology franchise, to advance new targeted therapies for cancer patients,” said Frank Diehl, CSO of Sysmex Inostics. “With our innovative technology for blood-based companion diagnostics we will open up new possibilities in personalized medicine together with Bayer.”

Companion diagnostic tests are designed to analyze the specific molecular characteristics of a patient’s tumor to help guide treatment decisions.The tests provide evidence which patients are more likely to respond to a particular anti-cancer agent. Under the master collaboration agreement, Sysmex Inostics will develop blood-based diagnostic tests based on its BEAMing technology. Sysmex Inostics BEAMing tests enable a very sensitive analysis of circulating tumor DNA shed into the blood stream from tumors which provides a non-invasive alternative to biopsies to obtain the mutational status of a patient’s tumor. This so called “liquid biopsy” allows the selection of an appropriate therapeutic agent without the need of further surgeries or biopsies. Moreover, blood-based diagnostic DNA tests can be performed on patients where no tumor tissue is available.

“We are excited to collaborate with the team at Sysmex Inostics on the development of companion diagnostic tests for our investigational anti-cancer agents,” said Prof. Andreas Busch, Head of Global Drug Discovery and Member of the Executive Committee of Bayer HealthCare. “Blood-based DNA tests provide diagnostics options for cancer patients without tumor biopsies being necessary. With this collaboration, we continue to strengthen our engagement in the field of personalized medicine with the aim of developing innovative therapies for cancer patients.”

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.About Sysmex InosticsSysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, BEAMing tests (OncoBEAM) are available through a CLIA certified laboratory for routine clinical analysis.Sysmex Inostics’ headquarters are located in Hamburg, Germany and Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com

About Sysmex Corporation

Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 6,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

 

 

Inostics is part of a Personalized Medicine Initiative with Geisinger and Indivumed

The collaboration will allow a comprehensive analysis of patient’s individual cancers including DNA sequencing, determination of protein expression and activity of therapy relevant cancer pathways. Indivumed staff will have access to tissue, blood and urine from consenting Geisinger patients who are already undergoing a surgical tumor resection. While Indivumed will concentrate on tissue testing to determine its molecular and biochemical profiles, Inostics will analyze plasma to determine therapy relevant cancer mutations and to monitor disease.

The overall goal is understanding the biological differences between tumors and how patients respond to treatments to support the implementation of personalized therapy.

Press release Geisinger Health System

Inostics’ blood test knows more

Inostics’ blood test, based on BEAMing Digital PCR technology, yielded a more informative summary of cancer mutations than a traditional biopsy. These findings come from a subanalysis of the phase III GIST–Regorafenib In Progressive Disease (GRID) trial presented at the AACR Annual Meeting 2013, held in Washington D.C., April 6-10.

Researchers compared whether BEAMing technology or traditional tissue analysis was better at detecting secondary resistance mutations in the KIT gene emerging after the disease had become resistant to imatinib and sunitinib. The BEAMing technology proved far superior, finding such mutations in 48 percent of the blood samples, compared to only 12 percent found in tissue samples.  

Read more:

2014

Sysmex Inostics GmbH to Collaborate with Merck KGaA

Sysmex Inostics GmbH to Collaborate with Merck KGaA to Develop and Commercialize a Blood-Based RAS Biomarker Test for Patients with Metastatic Colorectal Cancer

Sysmex Corporation announces that a collaboration agreement has been signed between Sysmex Inostics, a subsidiary of Sysmex Corporation, and Merck as outlined below.

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced a collaboration agreement with Merck through its biopharmaceutical division Merck Serono, for the development and commercialization of a RAS kit for patients with metastatic colorectal cancer (mCRC).

“We are looking forward to this important collaboration with Merck Serono and to bringing our innovative technology to mCRC patients,” said Fernando Andreu, CEO of Sysmex Inostics. “Together, with our non-invasive, blood-based diagnostics and Merck Serono’s expertise in personalized medicine, we will open up new possibilities to advance biomarker testing in mCRC. This collaboration is another major step in enhancing the clinical value of Sysmex Inostics’ OncoBEAM™ tests and exemplifies Sysmex’s overall strategy to bring sensitive blood-based testing to the oncology field.”

Under the terms of the agreement, Sysmex Inostics will develop blood-based RAS diagnostic tests based on its BEAMing technology for patients with metastatic colorectal cancer. Sysmex Inostics’ BEAMing tests enable a very sensitive analysis of circulating tumor DNA shed into the blood stream. These tests provide a non-invasive alternative to traditional biopsies in determining the mutational status of a patient’s tumor. These blood-based biomarker tests allow for the selection of an appropriate therapeutic agent without the need for further surgeries or biopsies. Moreover, blood-based diagnostic DNA tests can be performed on patients where no tumor tissue is available.

“We are delighted to announce our strategic partnership with Sysmex Inostics,” said Belén Garijo, President and CEO of Merck Serono. “As a company, we have embraced the principles of personalized medicine and predictive biomarkers. This collaboration reflects our commitment to leveraging our expertise in personalized medicine and predictive biomarkers in order to enhance Erbitux’s value proposition for patients, physicians and payers.”

 

About Merck KGaA

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

About Sysmex Inostics GmbH

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, BEAMing tests (OncoBEAM™) are available through a CLIA certified laboratory for routine clinical analysis. 

Sysmex Inostics’ headquarters are located in Hamburg, Germany and Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Sysmex Corporation

Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R & D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 6,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

 

 

2015

Sysmex Inostics and Merck Serono announce first RAS testing center implementing Sysmex Inostics’ blood-based OncoBEAM™ testing in Spain: Important milestone for mCRC patients

Sysmex Inostics today announced the first RAS biomarker testing site offering their blood-based OncoBEAM™ tests in Spain.

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced the first RAS biomarker testing site offering their (Sysmex Inostics) blood-based OncoBEAM™ tests in Spain. Aside from Sysmex Inostics' US-based CLIA certified laboratory, the Vall d'Hebron Institute of Oncology located in Barcelona, Spain, will be the first of numerous medical centers globally to use OncoBEAM™ assays for patients with metastatic colorectal cancers (mCRC) once CE Mark is received. This marks an important milestone in Sysmex Inostics' collaboration with Merck's biopharmaceutical business, Merck Serono, for the development and commercialization of a RAS biomarker testing kit for patients with mCRC, which was signed at a ceremony coinciding with the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, U.S in June 2014.

"This is a significant step in our collaboration with Merck Serono", said Fernando Andreu, CEO of Sysmex Inostics. "We are pleased to have Vall d'Hebron's Institute of Oncology as the first institution to offer our highly sensitive OncoBEAM™ tests for blood-based diagnostics. This collaborative approach between Merck Serono and Sysmex Inostics along with the reputation and expertise of Vall d'Hebron is another major step in advancing personalized medicine for metastatic colorectal cancer patients and enhancing the value of our clinical OncoBEAM™ assays".

The blood-based RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days which, in turn, can help guide treatment decisions.1 In addition, such testing may become the method of choice where a tissue specimen is difficult to obtain - for example in patients whose physical condition does not allow for a surgical procedure. Approximately half of patients with mCRC present with tumors with RAS mutations. Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.3-9

"We are excited that within less than one year of announcing our collaboration with Sysmex Inostics we are already making significant progress in bringing this new blood-based RAS biomarker test to patients in one of Europe's leading oncology centers," said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare, at the opening event in Barcelona. "Merck Serono is committed to improving patient outcomes and supporting clinicians in advancing the standard of care in metastatic colorectal cancer, and we are delighted that we will soon be able to offer a new method of RAS biomarker testing to the international oncology community."

Vall d'Hebron's Institute of Oncology will use blood samples from mCRC patients to advance research into RAS biomarkers. The ability to test for these mutations at Vall d'Hebron with a potentially quicker and easier testing method could improve the standard of care for patients.

"As patients with metastatic colorectal cancer (mCRC) can respond differently to various treatments, it is important to understand more about the tumor, especially its biology and genetics," said Professor Josep Tabernero, Head of the Medical Oncology Department of Vall d'Hebron University Hospital. "Once this liquid biopsy RAS biomarker test has received its CE mark it will become an important advance in testing mCRC patients and be a usefultool for treatment decisions. The liquid biopsy method can potentially save time, compared with current tissue-based RAS testing, and spares patients of a tissue biopsy or surgical procedure. We will only need a sample of blood, and we can then potentially provide resultsin 2-3 days".

Sysmex Inostics highly sensitive RAS OncoBEAM™ tests allow for molecular genetic analysis of cell-free tumor DNA from blood or plasma, delivering an individualized approach to complement treatment decision-making in oncology.

 

References

  1. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.
  2. Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.
  3. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
  4. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
  5. Bokemeyer C, et al. Oral presentation at the 2014 American Society of ClinicalOncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
  6. Stintzing S, et al. Oral presentation at the 2014 European Society of MedicalOncology Annual Meeting, September 26-30, 2014. Abstract No:LBA11.
  7. Van Cutsem E, et al. J Clin Oncol 2015;pii: JCO.2014.59.4812.
  8. Erbitux® (cetuximab) SmPC, 2014. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000558/WC500029119.pdf. Last accessed February2015.
  9. Vectibix® (panitumumab) SmPC, 2014. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000741/WC500047710.pdf. Last accessed February2015.

About Merck Serono
Merck Serono is the biopharmaceutical business of Merck. With headquarters in Darmstadt,Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. For more information, please visit www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials - and generated total revenues of € 11.1 billion in 2013. Around 39,000 Merck employees workin 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck is the world's oldest pharmaceutical and chemical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

About Sysmex
InosticsSysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as BEAMing and Plasma Sequencing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. With BEAMing being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' OncoBEAM™services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM™ tests are available through a CLIA certified laboratory for routine clinical analysis. Sysmex Inostics' headquarters are located in Mundelein, IL; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM™ blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.info@sysmex-inostics.com

 

About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership indiagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 6,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

Sysmex Inostics announces agreement with IndivuTest to offer Sysmex Inostics blood based mutation testing in Germany, Austria and Switzerland

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced that they have signed an exclusive distributor agreement with IndivuTest GmbH, and its parent company Indivumed GmbH, a cancer research company focused on the development of individualized cancer diagnostics and therapies. This collaboration will offer Sysmex Inostics OncoBEAM™ CLIA laboratory services throughout Germany, Austria and Switzerland. IndivuTest will be responsible for commercial and sample logistics, with all testing being performed in the Sysmex Inostics' CLIA laboratory in Baltimore, Maryland.

Sysmex Inostics' highly sensitive OncoBEAM™ services allow for molecular genetic analysis of cell-free tumor DNA from blood or plasma, delivering an individualized approach to complement treatment decision-making in oncology. OncoBEAM™, a non-invasive platform, reveals new possibilities for cancer management, while minimizing costs and risks inherent with tissue biopsies. The OncoBEAM™ assays target a wide variety of clinically actionable genetic mutations in various cancers like melanoma, colorectal, breast and lung cancer, delivering information in real-time to support therapy selection, detection of emergent mutations and assessment of drug response.

"We are delighted to partner with IndivuTest as our distributor for clinical OncoBEAM™ tests," commented Vishal Sikri, Vice President of Commercial Operations at Sysmex Inostics. "Sysmex Inostics is committed to driving precision medicine and one of our initiatives is to expand access to the OncoBEAM™ testing services outside of the United States. We are extremely excited to be able to provide our services to cancer patients in the DACH region through IndivuTest, as OncoBEAM™ offers a significant enhancement to clinical care over traditional tissue-based molecular testing."

Sikri went on to state that "IndivuTest is an ideal partner to introduce the full range of our CLIA-certified laboratory service portfolio to German, Austrian and Swiss oncologists and pathologists and we are proud to provide our customers with such a high level of service and local support."

Hartmut Juhl, MD, President and Chief Executive Officer of IndivuTest, as well as its parent company Indivumed GmbH stated that "this most recent collaboration with Sysmex Inostics is a tremendous opportunity for our companies to continue our long standing partnership, bringing targeted diagnostics and therapies to the bedside of cancer patients." Juhl went on to point out that Sysmex is a trusted partner of the Indivumed Group of companies, having successfully acquired Inostics from Indivumed in 2013. "Our companies share a vision to help every cancer patient attack their disease in the most effective and targeted manner possible" said Juhl.

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets.

With BEAMing being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' OncoBEAM™ services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM™ tests are available through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Indivumed and IndivuTest
INDIVUMED has established the world's leading high-content tumor database and biobank of the highest quality to support the development of new cancer companion diagnostics and therapies. Alongside the implementation of a highly standardized biospecimen collection process and a unique clinical infrastructure with clinical partners in Germany and the US, INDIVUMED offers a broad range of specialized research services to both biopharmaceutical companies and academia, as well as actively performing a cancer biomarker development program. With its subsidiary IndivuTest GmbH, INDIVUMED provides high-quality tissue-based tumor analysis to patients and has started an initiative with oncologists in Germany and the US to improve personalized cancer therapy strategies in clinical procedures. For more information about Indivumed and IndivuTest, please refer to the following - indivumed.com and indivutest.com

Sysmex and LabCorp Announce a Strategic Collaboration for Blood-Based Molecular Testing Services and Products to Support the Development of Precision Medicine in Oncology

Sysmex Corporation (TSE:6869) and Laboratory Corporation of America® Holdings (LabCorp®) (LH: NYSE) today announced a strategic collaboration focused on the development of blood-based molecular diagnostic tests to advance precision medicine in oncology. The collaboration combines Sysmex Inostics' strength in the development of innovative blood-based diagnostic solutions with LabCorp's unparalleled capabilities: global leadership in precision medicine through Covance Drug Development's (Covance) extensive involvement in oncology clinical trials and a unique ability to commercialize clinically-relevant diagnostic tests through LabCorp Diagnostics as such applications are developed.

The Sysmex OncoBEAM™ and Plasma Sequencing assays allow for molecular genetic analysis of cell-free tumor DNA from blood samples. These technologies, often referred to as liquid biopsies, provide non-invasive alternatives to biopsies under specific circumstances and are designed to determine the mutational status of a patient's tumor. These highly-sensitive methods allow for the potential selection of appropriate therapeutic agents and, in some cases, may eliminate the need for further surgeries or biopsies. Moreover, blood-based diagnostic DNA tests can be performed when no tumor tissue is available and utilized to serially monitor tumor changes in patients over time or in response to therapeutic treatment. The OncoBEAM™ assays target a wide variety of clinically actionable genetic mutations in cancer and, along with sequencing-based evaluation of circulating tumor DNA through Plasma Sequencing, offer biopharmaceutical companies powerful tools for developing new therapeutic options.

Under the terms of this collaboration, Sysmex Inostics will provide reagents and, when appropriate, services to enable Covance's central laboratory to perform OncoBEAM™ and Plasma Sequencing testing services in its global locations to support oncology clinical trials. In addition, as clinical utility of these technologies is further characterized through ongoing clinical trials, the parties will evaluate opportunities to develop commercial applications for Sysmex's technologies in clinical diagnostics.

"We are very pleased to enter into this strategic collaboration with LabCorp," said Hisashi Ietsugu, Chairman and CEO of Sysmex Corporation. "This collaboration will allow us to expand Sysmex Inostics' testing services and products using LabCorp's worldwide network of central laboratory locations and potentially accelerate the development of new cancer therapies. Further, as clinical evidence develops, Sysmex and LabCorp will evaluate opportunities together to commercialize precision medicine in oncology in support of improved patient outcomes."

"As an industry leader in delivering both world-class diagnostics and drug development services, we are uniquely positioned to provide comprehensive testing solutions in the growing cancer market," said David P. King, Chairman and CEO of LabCorp. "Our expanded relationship with Sysmex furthers our ability to bring innovative technologies that assist in the development of new oncology treatments to patients and builds upon our core mission of improving health and improving lives."

About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 7,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit http://www.sysmex.co.jp/en/ .

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as BEAMing and Plasma Sequencing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets.

With BEAMing being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' OncoBEAM™ services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM™ tests are available through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters and Service Laboratory are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM™ blood testing and the BEAMing and Plasma Sequencing technologies, refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500 company, is the world's leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics, and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people's health by delivering the combination of world-class diagnostics, drug development and knowledge services. With combined revenue proforma for the Covance acquisition in excess of $8.5 billion in 2014 and more than 48,000 employees in over 60 countries, LabCorp offers innovative solutions to healthcare stakeholders. LabCorp clients include physicians, patients and consumers, biopharmaceutical companies, government agencies, managed care organizations, hospitals, and clinical labs. To learn more about Covance Drug Development, visit www.covance.com. To learn more about LabCorp and LabCorp Diagnostics, visit www.labcorp.com.

This press release contains forward-looking statements including with respect to estimated 2015 guidance and the impact of various factors on operating results. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace, adverse actions of governmental and other third-party payers and the results from the Company's acquisition of Covance. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp's operating and financial results is included in the Company's Form 10-K for the year ended December 31, 2014, including in each case under the heading risk factors, and in the Company's other filings with the SEC, as well as in the risk factors included in Covance's filings with the SEC. The information in this press release should be read in conjunction with a review of the Company's filings with the SEC including the information in the section of the Company's Form 10-K for the year ended December 31, 2014, subsequent Forms 10-Q, under the heading MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

LabCorp Investor/Media Contact:
Paul Surdez - 336-436-5076 Company Information: www.labcorp.com 

 

Sysmex Corporation Investor/Media Contact:
Noriko Okada - +81-(0)78-265-0508 Company Information: http://www.sysmex.co.jp/en/ 

 

Sysmex Inostics Investor/Media Contact:
Friederike Lehmann - +49-(0)40-325907-531 Company Information: www.sysmex-inostics.com 

Sysmex Inostics’ expanded OncoBEAM™ RAS blood test demonstrated a high degree of concordance to tissue-based testing in a study presented at ESMO World GI

Sysmex Inostics' expanded OncoBEAM™ RAS blood test performed on circulating tumor DNA from plasma demonstrated a high degree of concordance to tissue-based testing in a study presented at the 17th ESMO World Congress on Gastrointestinal Cancer held on 01 - 04 July 2015 in Barcelona, Spain.

The study was initiated to determine whether blood-based RAS mutation testing is an appropriate surrogate for tissue-based RAS testing to assess eligibility of metastatic colorectal cancer patients to receive anti-EGFR therapy. RAS mutation status in ctDNA present in plasma was determined using a Sysmex Inostics OncoBEAM™ RAS 33 mutation panel. The results showed a 95.5% overall concordance in stage IV and 93.5% overall concordance when stage III patients were included as compared to Standard of Care RAS testing of FFPE tumor tissue. These results indicate that blood-based RAS mutation testing is a viable alternative to tissue-based testing for determining eligibility of mCRC patients for anti-EGFR therapy.

Blood-based RAS biomarker test now available in Germany

Targeted therapy for metastatic colorectal carcinoma (mCRC) is possible through identification of the RAS mutation status.

Targeted therapy for metastatic colorectal carcinoma (mCRC) is possible through identification of the RAS mutation status. Using the OncoBEAM® RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, the RAS mutation status can now also be determined using the blood: a rapid and simple method allowing even more patients to have access to personalized mCRC therapy.

Optimization of therapy planning - a single blood-draw is sufficient
The first center of excellence for RAS biomarker testing in Germany offering the new test procedure was opened at Universitätsklinikum Knappschaftskrankenhaus Bochum during a joint press conference involving both companies and the Ruhr University Bochum. "With the blood-based mutation test we receive the results within only a few days - this is precious time that we gain for planning the therapy", says Prof. Wolff Schmiegel, director of the new center. The highly sensitive OncoBEAM® RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success1.

The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment2-5. The certification of conformity with the European harmonized directives (CE-labelling) is expected in the coming months, which will allow using the test in routine for patient diagnosis.

Targeted: Relevance of biomarkers for therapy success
Predictive biomarkers are important in oncology for the effectiveness and individual response to the therapy. With RAS mutation analysis, a mCRC targeted therapy is possible: Studies show that patients with KRAS and NRAS wild type tumors can benefit from a therapy with the EGFR antibody. Therefore, identification of the RAS mutation status is crucial for therapy planning of RAS wild type mCRC patients6.

Personalized medicine: Driving progress forward through collaboration
"Merck is researching biomarkers and appropriate further diagnostics in order to allow cancer patients access to personalized therapies. The collaboration with Sysmex Inostics has enabled us to make significant progress in this", emphasizes Dr. Bettina Bauer, Director of the Business Unit Oncology, Merck Serono GmbH. "With the new CRC blood test our common goal is to provide physicians with crucial information for selecting the therapy, and to give the patient considerably value", states Dr. Michael Schaefer, Managing Director of Sysmex Inostics GmbH. "Sysmex Inostics is committed to driving precision medicine and we will continue to expand our liquid biopsy product pipeline to improve the standard of care for patients". Both companies are collaborating with various partners in industry and research institutes to continue pushing forward with personalized medicine in the area of oncology.

OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

 

 

References

  1. Diaz and Bardelli 2014 J Clin Oncol 32.579−86
  2. Sorich et al. 2015 Annals Oncol 26.13-21
  3. NCCN guidelines colon cancer 3.2015
  4. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
  5. www.ema.europa.eu/ema
  6. Van Cutsem et al., 2015 J Clin Oncol 33.692-700

 

About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of €11.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials. Further information can be found at www.merckserono.de or www.merckgroup.com.

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM® blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment.

Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM® tests are available through a CLIA certified laboratory for routine clinical analysis. Sysmex Inostics' headquarters are located in Mundelein, IL; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

 

[Image: © Andreas Beyna, Universitätsklinikum Knappschaftskrankenhaus Bochum]

2016

Sysmex signs supply and distribution agreement with Streck

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced that Sysmex Corporation has signed a worldwide supply and distribution agreement with Streck, Inc. The agreement allows Sysmex to supply Streck Cell-Free DNA BCT® and Streck Cell-Free DNA BCT® CE blood collection tubes as part of their medical diagnostic products and services.

"Streck is recognized worldwide for its innovative direct-draw blood collection tubes. Our internal studies have shown that Streck Cell-Free DNA BCT® blood collection tubes are ideal for stabilizing cell-free DNA to allow for efficient and effective collection and transport of specimens at ambient temperatures. As a result, we are including the Streck blood collection tubes with our products and services associated with our OncoBEAM™ assays," said Vishal Sikri, Vice President of Commercial Operations at Sysmex Inostics.

"Streck's partnership with Sysmex spans more than three decades," said Connie Ryan, President and CEO at Streck. "Our new agreement with Sysmex supports the collaboration of that long-term partnership and the expansion of our product portfolio."

Sysmex Inostics' highly sensitive molecular diagnostic testing solutions allow for molecular genetic analysis of cell-free tumor DNA from blood or plasma, delivering an individualized approach to complement treatment decision-making in oncology. Their minimal-invasive nature reveals new possibilities for cancer management, while minimizing costs and risks inherent with tissue biopsies.

About Streck
Streck is an industry leader in the development and manufacturing of products for clinical and research laboratories. The company's pursuit of innovative solutions has produced an extensive list of patented products. Streck's core technology is cell stabilization; product lines support the fields of hematology, immunology and molecular biology. For more information, please visit www.streck.com.

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as BEAMing and Plasma Sequencing. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets.

With BEAMing being one of the most sensitive technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics' OncoBEAM™ services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM™ tests are available through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Mundelein, IL; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM™ blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for cell, gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, the Middle East, Africa, China and Asia Pacific and employs more than 7,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

 

Blood-based RAS biomarker test now available in Slovakia

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced its first RAS biomarker testing site in Slovakia opening at Martinské bioptické centrum, spol. s.r.o. (Martin´s Biopsy Center. Ltd.). The center will offer Sysmex Inostics blood-based OncoBEAM® test which is a non-invasive, fast method to determine the RAS status crucial for therapy planning of RAS wild type mCRC patients1.

The highly sensitive OncoBEAM® RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success2. "The OncoBEAM® test result can be available within only a few days, supporting treatment decisions immediately", says Prof. Lukás Plank, director of the new center. "This is valuable time that we gain for therapy planning".

The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment3-6. The certification of conformity with the European harmonized directives (CE-labelling) is expected this month, allowing routine use of the test for patient diagnosis.

OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

References

  1. Van Cutsem et al., 2015 J Clin Oncol 33.692-700
  2. Diaz LA Jr and Bardelli A. J Clin Oncol 2014;32(6):579−86.
  3. Sorich et al. 2015 Annals Oncol 26.13-21
  4. NCCN guidelines colon cancer 3.2015
  5. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9
  6. www.ema.europa.eu/ema


About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM® blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment.

Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, OncoBEAM® tests are available through a CLIA certified laboratory for routine clinical analysis.

Sysmex Inostics' headquarters are located in Mundelein, IL; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

New liquid biopsy RAS testing for metastatic colorectal cancer patients now available for clinical practices

Sysmex Inostics today announced that its OncoBEAM® RAS CRC test has been granted CE Mark approval.

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced that its OncoBEAM® RAS CRC test has been granted CE Mark approval. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic colorectal cancer (mCRC) across Europe. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing1-3 and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data.4-8

"We have achieved a significant milestone with the CE Mark of the OncoBEAM® RAS colorectal cancer assay," said Fernando Andreu, CEO of Sysmex Inostics. "Together with Merck, we are advancing biomarker testing in metastatic colorectal cancer, and we are already seeing strong acceptance and uptake of the test in pilot centers, with clinicians globally recognizing the clinical value of a blood-based test."

"In keeping with our philosophy of patient focus, we strive to evaluate all aspects of the patient journey, to focus our efforts on projects that improve treatment experience and outcomes for the patients," said Rehan Verjee, Chief Marketing and Strategy Officer of Merck's biopharma business. "The CE mark approval of the liquid biopsy RAS biomarker test is therefore a pivotal milestone for patients with metastatic colorectal cancer, as it allows for informed and rapid treatment decisions. We, with our partner Sysmex Inostics, can now start making this test available to more patients around the world."

The highly sensitive OncoBEAM® RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the test has the potential to provide mutation status results within days, which can help guide quicker treatment decisions. Moreover, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success.9

"As the first test center to use the liquid biopsy RAS biomarker testing technology we have seen firsthand how this technology has advanced treatment decision-making," said Professor Josep Tabernero, Director Head of the Medical Oncology Department of Vall d'Hebron University Hospital, Spain. "The speed at which the test results become available has helped us initiate effective treatments faster, which has led to improved patient outcomes."

The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment.10-13 Now with the CE Mark, it is expected to be widely implemented across Europe, Asia, Latin America, and Australia by the end of 2016.

OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

About mCRC
Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.14 Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.4-8 Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.15 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.15 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.15

 

About CE Marking
CE Mark is a mandatory conformity marking for certain products sold within the European Economic Area, and is a declaration that the product meets the essential requirements of the applicable EC directives.

References

  1. Hahn S, et al. Eur J Cancer 2015;51(suppl 3):S79.
  2. Jones F, et al. Poster discussion presentation at the European Cancer Congress 2015, September 25-29, 2015.
  3. Scott R, et al. Ann Oncol 2015;16(suppl 4):iv1-iv100.
  4. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34. 
  5. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
  6. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
  7. Stintzing S, et al. Oral presentation at the European Society for Medical Oncology Congress, September 26-30 2014. Abstract No:LBA11. 
  8. Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3506.
  9. Diaz LA and Bardelli A. J Clin Oncol. 2014;32(6):579−86. 
  10. Sorich et al. 2015 Annals Oncol 26.13-21 
  11. NCCN guidelines colon cancer 3.2015 
  12. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9 
  13. www.ema.europa.eu/ema 
  14. Vaughn CP, et al. Genes Chromosomes Cancer 2011;50(5):307−12.
  15. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: globocan.iarc.fr. Accessed April 2016.

 

About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of €12.8 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM® blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment.

Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process.

Sysmex Inostics' headquarters are located in Mundelein, IL; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland; Sysmex Inostics' Service Laboratory is located in Hamburg, Germany. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 40 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R & D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, China and Asia Pacific and employs more than 7,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

Blood-based IVD RAS biomarker test now available in France

RAS biomarker testing site  opening at the Biopathology department of the ICL, Nancy

Nancy, France - Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced its first RAS biomarker testing site in France opening at the Biopathology department of the Institut de Cancérologie de Lorraine (ICL), Nancy. The center will offer Sysmex Inostics blood-based OncoBEAM® IVD test, developed by Sysmex Inostics GmbH in collaboration with Merck, which is a non-invasive, fast method to determine the RAS status crucial for therapy planning of RAS wild type mCRC patients.

"With the blood-based mutation test we aim at a dramatic reduction of the delay for mutation analysis and therefore accelerated optimized initiation of personalized therapy ", says Prof. Jean-Louis Merlin, head of the Tumor biology Unit of the new center.

Determining RAS mutations in circulating cell-free DNA with the OncoBEAM® RAS CRC test is highly sensitive, and only requires a single blood-draw. Thus, the blood-based test, also called liquid biopsy, represent an alternative to tumor tissue-based test that requires biopsies or other surgical specimen. This test can also be performed when no tumor tissue is available or when reducing the delay for providing the result is crucial for therapy success. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing1-3 and can be used to determine which patients would benefit from anti-EGFR therapies, such as Erbitux, as demonstrated by recent data.4-8

The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment9-12. The certification of conformity with the European harmonized directives (CE-labelling) has been granted in April 2016 allowing its use in routine for patient diagnosis.

As of April 2016, and under the acronym "ColoBEAM", the ICL is conducting a multicenter prospective study comparing the implementation in real-life clinical practice of OncoBEAM® RAS CRC test on blood to standard test on formalin fixed and paraffin embedded tumor tissue.

OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

 

References

  1. Hahn S, et al. Eur J Cancer 2015;51(suppl 3):S79. 
  2. Jones S, et al. Poster discussion presentation at the European Cancer Congress 2015, September 25-29, 2015.
  3. Scott R, et al. Ann Oncol 2015;16(suppl 4):iv1-iv100.
  4. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
  5. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
  6. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
  7. Stintzing S, et al. Oral presentation at the European Society for Medical Oncology Congress, September 26-30 2014. Abstract No:LBA11.
  8. Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3506.
  9. Sorich et al. 2015 Annals Oncol 26.13-21 
  10. NCCN guidelines colon cancer 3.2015
  11. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9 
  12. www.ema.europa.eu/ema

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM® blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process.

Sysmex Inostics' headquarters and Service Laboratory are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com. 

Sysmex Inostics announces the opening of its global training center for the OncoBEAM™ platform in Barcelona, Spain

Sysmex Inostics, a subsidiary of Sysmex Corporation, today announced the opening of a global OncoBEAM™ Training Center in Barcelona. The new state-of-the-art facility is designed to educate and train customers from all over the world on the Sysmex Inostics OncoBEAM™ technology platform and the recently released OncoBEAM™ RAS CRC test. The OncoBEAM™ RAS CRC test is the first CE-Mark liquid biopsy assay helping oncologists determine the most effective therapy for patients with metastatic colorectal cancer.

"The opening of our Training Center marks an important milestone for us as we now have a dedicated facility for educating and training our customers on the OncoBEAM™ molecular diagnostic assays in oncology." said Fernando Andreu, CEO of Sysmex Inostics.

Sysmex Inostics' highly sensitive molecular diagnostic testing solutions allow for genetic analysis of cell-free tumor DNA from blood, delivering an individualized approach to complement treatment decision-making in oncology. Blood based molecular testing allows for new possibilities for cancer management, while minimizing costs and risks inherent with tissue biopsies. Sysmex Inostics' comprehensive OncoBEAM™ RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw allowing for informed and rapid treatment decisions. The OncoBEAM™ RAS CRC test will be widely implemented across Europe, Asia, Latin America and Australia by the end of 2016.

OncoBEAM™ is a trademark of Sysmex Corporation. OncoBEAM™ is distributed and marketed by Sysmex.

 

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM™ blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment.

Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process.

Sysmex Inostics' headquarters and Service Laboratory are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM™ blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

Sysmex Inostics blood-based RAS biomarker test now available in Italy

Naples, 05.07.2016 - Assessing RAS mutation status in patients with mCRC has shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies can improve outcomes in patients with RAS wild-type mCRC. Using the OncoBEAM® RAS CRC test, developed by Sysmex Inostics GmbH in collaboration with Merck, the RAS mutation status can now also be determined using the blood: a rapid and simple method allowing even more patients to have access to personalized mCRC therapy. This should reduce the clinical turn around time for Oncologists allowing them to make informed therapy decisions in a timely manner and reducing the complications for patients currently undergoing tissue biopsies. The first center of excellence that implemented the OncoBEAM® RAS test in Italy is the Centro di Ricerche Oncologiche di Mercogliano (CROM) in Naples.

The highly sensitive OncoBEAM® RAS CRC test is a simplified method for determining the RAS mutation status of tumors, which requires only a single blood-draw. Thus, the blood-based test is an alternative to tissue biopsies or other surgical procedures, and can also be performed when no tumor tissue is available or a rapid test result is crucial for therapy success. The OncoBEAM® RAS CRC assay has been shown to have similar performance to conventional tissue-based testing1-3 and can be used to determine which patients would benefit from anti-EGFR therapies, such as Cetuximab, as demonstrated by recent data.4-8

"In mCRC, RAS is known to be a key biomarker to predict how well mCRC patients may respond to particular treatments, making it important to know their RAS status as early as possible. The OncoBEAM® CRC RAS test can save time, compared with current tissue-based RAS testing. The liquid biopsy test can also be used as an alternative if tissue for testing is not available." says Prof. Nicola Normanno, director of the Pharmacogenomics laboratory at CROM.

The OncoBEAM® RAS assay is a comprehensive test which includes 34 KRAS and NRAS mutations reflecting the recommendations of the NCCN, ESMO as well as EMA guidelines to determine the RAS mutation status before initiating treatment9-13. The certification of conformity with the European harmonized directives (CE-labelling) has been granted in April 2016 allowing its use in routine for patient diagnosis.

OncoBEAM® is a registered trademark of Sysmex Corporation. OncoBEAM® is distributed and marketed by Sysmex Inostics, Hamburg, Germany.

References 

  1. Hahn S, et al. Eur J Cancer 2015;51(suppl 3):S79.
  2. Jones S, et al. Poster discussion presentation at the European Cancer Congress 2015, September 25-29, 2015.
  3. Scott R, et al. Ann Oncol 2015;16(suppl 4):iv1-iv100.
  4. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
  5. Schwartzberg LS, et al. J Clin Oncol 2014;32(21):2240-7.
  6. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3505.
  7. Stintzing S, et al. Oral presentation at the European Society for Medical Oncology Congress, September 26-30 2014. Abstract No:LBA11. 
  8. Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014. Abstract No:3506.
  9. Sorich et al. 2015 Annals Oncol 26.13-21
  10. NCCN Clinical Practice Guidelines in Oncology™: Colon Cancer. 
  11. National Comprehensive Cancer Network. V2, 2016. 
  12. Van Cutsem et al. 2014 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals Oncol 25 (Supplement 3): iii1-iii9 
  13. www.ema.europa.eu/ema

 

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection in blood through highly sensitive molecular methods. Our OncoBEAM® blood-based tests deliver a minimally invasive alternative for sensitive real time molecular diagnostics to improve cancer characterization and treatment. Sysmex Inostics is a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive cell-free DNA-based IVD tests supported by a growing network of partners to cover the entire IVD development process.

Sysmex Inostics' headquarters and Sysmex Inostics' Service Laboratory are located in Hamburg, Germany; Sysmex Inostics' Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM® blood testing and the BEAMing technology refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.