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.

Thirty (30) tests/kit

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.

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. J Clin. Oncology 34, 179 – 85, 2016.
5. Jones, F. et al. Performance of standardized BEAMing platform for detecting RAS mutations in the blood of metastatic colorectal
   cancer (mCRC) patients, ASCO 2016
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).