FDA-approved Therascreen® KRAS mutation in vitro diagnostic (IVD) test for colorectal adenocarcinoma

PhenoPath Laboratories is pleased to announce that we are offering the FDA-approved Therascreen® KRAS mutation in vitro diagnostic (IVD) test for colorectal adenocarcinoma. The Therascreen® KRAS mutation assay is a real-time, allele-specific PCR assay that uses Scorpian ARMS® technology to detect the most common KRAS mutations that involve codons 12 and 13.  This is the only FDA-approved assay for KRAS mutations in colorectal adenocarcinoma and as the sole FDA-approved KRAS mutation test available, it is a requirement for determining patient eligibility for the anti-EGFR antibody drug cetuximab (Erbitux®). Additionally, KRAS mutational status determination is a requirement under current National Comprehensive Cancer Network (NCCN)  Practice Guidelines^TM for colorectal adenocarcinoma.

The KRAS oncogene is a key signal transduction molecule that is downstream of the EGFR receptor tyrosine kinase.  The codon 12 and 13 mutations tested for by the Therascreen® KRAS mutation assay result in a constitutively activated KRAS molecule that can no longer be negatively regulated by EGFR antibody blockade.  In clinical trials, patients with tumors negative for a KRAS mutation (wild-type KRAS) were found to be responsive to anti-EGFR antibody therapy (Erbitux®). In contrast, patients with KRAS mutation positive tumors were found to be nonresponsive to such therapy.  Therefore, KRAS mutation status is required to determine patient eligibility for Erbitux® therapy. 

Please contact us at lab@phenopath.com should you have any questions regarding KRAS testing in colorectal adenocarcinoma. 

References
1.  Karapetis CS et al.  N Engl J Med 2008  Oct 23:359(17):1757-65
2.  Lievre A et al.  J Clin Oncol 2008 Jan 20;26(3):374-9
3.  Amado RG et al. J Clin Oncol 2008 Apr 1;26(10):1626-34