Targeted Molecular Diagnostics (TMD) announces the commercial availability of a new clinical laboratory test to identify colorectal cancer (CRC) patients who may be resistant to EGFR targeted monoclonal antibody therapies. Recently, colorectal cancer patients who harbor KRAS mutations were shown to have no response to antibody-based EGFR therapies such as cetuximab and panitumumab. Mutated KRAS genes have been detected in about 40% of metastatic colorectal cancers. In one study, TMD identified mutations in 43% of CRC patients using the Real-Time PCR platform. TMD’s KRAS Mutation Assay may help identify patients who harbor specific KRAS mutations and therefore may not respond to EGFR inhibitors.

The TMD KRAS Mutation Assay, utilizes SNP-based Real-Time PCR technology to identify 7 of the most common KRAS mutations in DNA from frozen or formalin fixed paraffin embedded (FFPE) tumor specimens. The Company selected a Real-Time PCR platform to overcome the sensitivity concerns associated with sequencing technologies that have been reported in the literature. The results of the assay are available within 5 business days (on average) from receipt of the specimen at TMD.