ONCOBEAM™ RAS CRC KIT IVD

  • Extensive 34 mutation KRAS and NRAS assay
  • High concordance with tissue
  • Rapid turnaround time from biopsy to result, minimally invasive
  • Accurate real-time information, no selection bias
  • Catalog Number ZR 150100

Clinically actionable information with a simple blood draw – The OncoBEAM™ RAS CRC KIT (CE-IVD)!

Go beyond KRAS - The All-RAS-Panel

Our understanding of the important RAS mutations in CRC has evolved over time. In 2008, KRAS mutations in Codons12 and 13 were the only mutations considered important in determining the appropriate therapy for metastatic colorectal cancer patients. Since that time, recent clinical studies have shown that the detection of additional mutations in KRAS and NRAS codons should also be considered in determining patient eligibility for targeted anti‐EGFR therapies.

The OncoBEAM™ RAS qualitative digital PCR based test is intended for the detection of gene mutations in KRAS codons 12, 13, 59, 61, 117, 146 and NRAS codons 12, 13, 59, 61, 117, 146 extracted from Stage IV colorectal cancer patient plasma. The kit is intended to aid the clinician in determining potential benefit of anti-epidermal growth factor receptor (EGFR) therapy to colorectal cancer patients.

Enhanced Clinical Value of OncoBEAM™ RAS Testing

Enhanced Clinical Value of OncoBEAM™ RAS Testing

A meta‐analysis of randomized, controlled trials (RCT) was conducted on the prevalence of RAS mutations in mCRC. Nine RCTs comprising a total of almost 6,000 participants were evaluated for both KRAS Exon 2 and new KRAS and NRAS mutations. The conclusion of the analysis is that patients with tumors exhibiting one of the new RAS mutations are unlikely to significantly benefit from anti‐EGFR therapy in mCRC.1
In 2015, guidelines were updated to recommend expanded RAS testing prior to use of an anti‐EGFR treatment.2-4 The inclusion of low frequency KRAS and NRAS mutations in Exons 2, 3 and 4 formed the basis for our comprehensive OncoBEAM™ RAS CRC kit.

Kit Format

Kit Format

Thirty (30) tests/kit

Limitations

Limitations

The test cannot differentiate between somatic and germline mutations without the analysis of matched normal cells. False negative and positive results may occur for the following reasons:

  1. Incorrect handling of blood samples or plasma samples (e.g. prolonged storage)
  2. Rare polymorphisms within the region of interest
  3. Heterogeneity of specimen
  4. High mutant samples might cause false positive results in neighboring samples. Use caution during workflow procedure and reanalyze test results for confirmation in case of doubt.

The test is not recommended for use for patients undergoing therapy, as low tumor burden may exist which may yield inaccurate results. BEAMing technology is a highly sensitive detection procedure that uses polymerase chain reaction (PCR), therefore use caution to avoid contamination of samples and reaction mixes by external sources of DNA and/or PCR product in the test environment and the DNA in the positive control.

Other mutations within the gene of interest or other genes are not analyzed with this test.

References

References

  1. Sorich et al. Extended RAS mutations and anti‐EGFR antibody survival benefit in metastatic colorectal cancer. Annals of Oncology 26: 13–21, 2015.
  2. NCCN Clinical Practice Guidelines in Oncology™: Colon Cancer. National Comprehensive Cancer Network. V2.2016
  3. Van Cutsem et al. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annals of Oncology 25 (Supplement 3): iii1–iii9, 2014.
  4. Allegra et al. Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinoma to Predict Response to Anti‐Epidermal Growth Factor Receptor Monoclonal AntibodyTherapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. JClin. Oncology 34, 179 – 85, 2016.
  5. OncoBEAM™ RAS CRC Kit Instructions for Use, OBMRASIVD.
  6. Schwaederle et al. Molecular tumor board: the University of California‐San Diego Moores Cancer Center experience. Oncologist 19, 631 – 636 (2014).
  7. Morris et al. Efficiency of biomarker screening for enriched metastatic colorectal cancer trials: The ATTACC program experience. J. Clin. Oncol. 32:5s (2014).
The OncoBEAM™ Advantages

The OncoBEAM™ Advantages

High Concordance with Tissue

OncoBEAM™ RAS CRC Kit demonstrated an overall percent agreement of 93.3 % with tissue 5

Safety and Convenience
Minimally invasive, few risks

Accurate Information
Blood sample evaluation represents current mutational status of patient's disease; Information of tumor dynamics in real time

No Selection Bias
Evaluate primary tumor and metastases with one sample

Ability to Monitor
Allows multiple measurements to assess drug response and resistance

Time Sensitive
Rapid turnaround time from biopsy to result 6,7

Contact

Sales Support

info@sysmex-inostics.com

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