Targeted Molecular Diagnostics Introduces KRAS Mutation Assay to Identify KRAS Mutations in Patients With Metastatic Colorectal Cancer

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 (DxS Diagnostics), 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 8-10 days from receipt of the specimen at TMD. TMD provides specimen collection kits for convenient collection and shipment of specimens.

TMD and DxS will sponsor a symposium on the profiling of solid tumor mutations for the purpose of directing targeted therapy at (ASCO) in Chicago, Ill. on June 1, 2008. You can register for this symposium and reception at www.tmdlab.com.

In addition to the new KRAS Mutation Assay, TMD offers other tests relevant to EGFR-guided therapies:

 —  EGFR by IHC (immunohistochemistry) is available through a program     known as the Targeted Diagnostic Advocacy Program (tdap(TM)), where TMD     performs EGFR screening of patient specimens with a 24 – 48 hour turn     around time.      —  EGFR by FISH (fluorescent in situ hybridization) which reports     amplification of the EGFR gene.      —  B-RafV600E mutation by SNP-based Real-Time PCR is found in many     metastatic CRC and melanoma patients. The ability to detect this mutation     may be valuable in the clinical development of inhibitors of B-RafV600E.      

TMD is dedicated to improving the survival and quality of lives of cancer patients by using biomarker technologies to support the development of targeted therapies. Located in Westmont, IL near Chicago, the company currently supports the development of numerous targeted therapies in oncology such as EGFR, HER2, SRC, MEK, PI3K, HDAC and VEGF inhibitors.

 Contact: Andrea Jones 630-789-1233 www.tmdlab.com

SOURCE: Targeted Molecular Diagnostics (TMD)