FAQs for Pharmaceutical/CRO Testing Services

What services does Sysmex Inostics offer to pharmaceutical companies?

Sysmex Inostics provides the following services to our pharmaceutical partners:

  • Biomarker Assay Development
  • Analytical and Clinical Validation
  • Regulatory Registration/Approval
  • cGMP Manufacturing
  • GCP/CLIA certified laboratory
  • Project Management
  • Companion Diagnostic (CDx) Kit Development and Commercialization

Where is Sysmex Inostics located?

We have laboratory operations in Hamburg, Germany and Baltimore, Maryland with our corporate headquarters based in Mundelein, Illinois. The Hamburg site is our central Good Clinical Practice (GCP) laboratory providing assay development and testing services for clinical trials and research. If our clients require analysis in a CLIA certified laboratory, samples can be sent to our Baltimore facility (which also provides testing services for Research Use Only (RUO) samples).

What is circulating cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA)?

Minute amounts of DNA are constantly released from normal cells and tumor cells into the bloodstream. These DNA molecules are described as circulating cell-free DNA (cfDNA). Cell-free DNA released from a tumor cell into the bloodstream is called circulating tumor DNA (ctDNA).

Reference: Fleischhacker M, Schmidt B. (2007): Circulating Nucleic Acids (CNAs) and Cancer – a Survey. Biochim Biophys Acta 2007; 1775(1):181 – 232.

What is the difference between ctDNA and CTCs?

Circulating tumor DNA (ctDNA) refers to small fragments of nucleic acid that are not associated with cells or cell fragments which are released from a tumor cell into the bloodstream. Circulating tumor cells (CTCs) are cells that are shed from primary and/or metastatic tumor deposits and circulate in the bloodstream.

There are indications that ctDNA is often present without detectable CTCs. ctDNA levels may be higher than CTCs in certain tumor types. Some studies have also shown that ctDNA has greater sensitivity for mutation detection in the circulation than CTCs.

Reference: Bettegowda C, Sausen M, Leary R, Kinde I, Wang Y, Agrawal N, et al. Detection of Circulating Tumor DNA in Early- and Late-Stage Human Malignancies. Sci Transl Med Feb 2014; 224(6):224ra24.

Why test for cfDNA?

Circulating cell-free DNA (cfDNA) can be present in higher levels among patients with cancer, as
compared to healthy individuals, and circulating cfDNA in cancer patients often shows the same
genetic and epigenetic alterations as DNA derived from related tumor tissue. These findings,
and the fact that circulating cfDNA can be isolated from blood and other body fluids, makes it
an important non-invasive approach to identifying the effectiveness of new personalized cancer
therapies in development.

Reference: Elshimali YI, Khaddour H, Sarkissyan M, Wu Y and Vadgama JV et al. The Clinical Utilization of Circulating Cell Free DNA in Blood of Cancer Patients. Int. J. Mol. Sci. 2013; 114 (9), 18925-18958.

Can BEAMing be used for all cancer types?

BEAMing can be used on most late stage metastatic cancers such as: lung, colorectal, pancreatic, prostate, breast and melanoma where the tumor has penetrated the circulatory system and released
ctDNA. Certain cancers, such as gliomas, have lower levels of detectable ctDNA.

Reference: Bettegowda C, Sausen M, Leary R, Kinde I, Wang Y, Agrawal N, et al. Detection of Circulating Tumor DNA in Early- and Late-Stage Human Malignancies. Sci Transl Med Feb 2014; 224(6):224ra24.

Is it possible to use the plasma BEAMing assay to monitor tumor dynamics?

Yes. Plasma mutation status correlates well with response to therapy and there is growing evidence that it can be used to predict disease progression.

Reference: Diehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating Mutant DNA to Assess Tumor Dynamics. Nature Medicine 2008; 14, 985 – 990.

What sample types are acceptable for BEAMing?

Frozen plasma is the preferred specimen type for our BEAMing assays. Plasma preparation and shipping procedures can be obtained from our website. We are currently working on a solution for the shipment of whole blood.

How much whole blood is required for a BEAMing assay?

We generally require 10 mL of blood collected in K2 EDTA tube, which results in approximately 4 mL of plasma. We require a minimum of 2 mL of plasma for each single or multi-gene assay. If there is less than 1 mL of plasma, assay sensitivity may be compromised.

Can BEAMing be used to test serum?

Serum is not ideal for BEAMing as the wild type background can be high and is likely to result in lower assay sensitivity. For clinical testing, all of our assays are validated using plasma.

Can BEAMing be used to test tissue?

Sysmex Inostics can perform tissue sample analysis alongside matched plasma analysis.

What is the turn-around time to obtain results?

The turn-around time for reporting results from our laboratories is dependent on the size and scope of the testing project and will be defined during contract negotiations.

How much does a known mutation test cost for Pharma/CRO testing?

The cost per assay varies depending on number of amplicons, number of mutations, number of total samples and additional services (reporting/quality assurance).

How many mutations can be multiplexed into a single assay?

Sysmex Inostics has not encountered any limitations regarding the number of mutations that can be performed in a single assay. The number of desired or required mutations will be discussed during contract negotiations.

Are there a minimum number of samples required?

Typically we require a minimum of 26 samples. There is a surcharge for less than 26 samples.

What are the costs of developing a new mutation BEAMing assay and how long does it take?

Costs and development time are highly variable and depends on the gene and mutations of interest. On average, development time for a new hot spot mutation assay will minimally take 6 – 8 weeks, not including validation.

What is the difference between BEAMing and PlasmaSeq applications and which one will best suit my testing need?

BEAMing is used for the detection of known mutations whereas Plasma-Seq is for de-novo (unknown) mutation discovery at broad sequence coverage, including detection of loss of function mutations in tumor suppressor genes.

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