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ONCOBEAM CRC RAS KIT

  • Extensive 34 mutation KRAS and NRAS assay
  • A more rapid turnaround time from biopsy to result
  • Proven BEAMing technologie

Clinically actionable information with a simple blood draw – The ONCOBEAM CRC RAS KIT!

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.

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. 
In 2015, guidelines were updated to recommend expanded RAS testing prior to use of an anti‐EGFR treatment4‐6. 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 (RUO).

Product Description

Product Description

The OncoBEAM RAS CRC Kit is a research use only (RUO) reagent kit for the qualitative detection of mutations in the human KRAS and NRAS oncogenes using DNA extracted from plasma.
The OncoBEAM RAS CRC Kit detects mutations in codons 12, 13, 59, 61, 117 and 146 of the KRAS and NRAS oncogenes against a background of wild‐type genomic DNA. The assay is run using the BEAMing digital PCR platform.

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:

  • Rare polymorphisms within the region of interest
  • Low tumor burden at the time of blood draw
  • Heterogeneity of specimen
  • Incorrect handling of blood samples or plasma samples (e.g. prolonged storage)Other mutations within the gene of interest or other genes are not analyzed with this test.
References

References

  1. Schwaederle, M et al. Molecular tumor board: the University of California‐San DiegoMoores Cancer Center experience. Oncologist 19, 631 – 636 (2014).
  2. Morris VK et al. Efficiency of biomarker screening for enriched metastatic colorectalcancer trials: The ATTACC program experience. J. Clin. Oncol. 32:5s (2014).
  3. Sorich et al. Extended RAS mutations and anti‐EGFR antibody survival benefit inmetastatic colorectal cancer. Annals of Oncology 26: 13–21, 2015.
  4. NCCN Clinical Practice Guidelines in Oncology™: Colon Cancer. National ComprehensiveCancer Network. V1.2016
  5. Van Cutsem et al. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines. Annalsof Oncology 25 (Supplement 3): iii1–iii9, 2014.
  6. Allegra, J et al. Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinomato Predict Response to Anti‐Epidermal Growth Factor Receptor Monoclonal AntibodyTherapy: Amercian Society of Clinical Oncology Provisional Clinical Opinion Update 2015. JClin. Oncology 33, 2015.
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