Response Genetics Inc. announced the commercial availability of its expanded KRAS assay, a mutation detection test that provides broader coverage of KRAS mutations, including those in regions of the gene not previously examined. KRAS mutation status is used to predict whether or not a patient will respond to anti-EGFR therapy, and assessing KRAS status is recommended in the NCCN guidelines for colorectal cancer. Recently, additional mutations in the KRAS gene were discovered in global, multicenter, randomized Phase 3 studies.

These studies showed that in addition to the well-studied mutations in exon 2 that predict for lack of response to anti-EGFR therapy, mutations in exon 3 and exon 4 may be important for anti-EGFR therapy selection.