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EpigenDx Inc. Approved for KRAS Mutation Genetic Testing

Hopkinton, MA company set to contribute to the advancement of personalized medicine.

Hopkinton, MA September 11, 2015: EpigenDx Inc. has been issued a Massachusetts Clinical Laboratory License to perform genetic testing for mutations in the KRAS gene of cancer patients, using the FDA-approved therascreen® KRAS RGQ Kit from Qiagen. This test indicates which patients with metastatic colorectal cancer may benefit from anti-EGFR therapy. Pathologists will now be able to send formalin-fixed paraffin embedded (FFPE) tissue sections and isolated DNA to EpigenDx for clinical genetic analysis of mutations in the KRAS gene. This will greatly improve treatment options for patients with metastatic colorectal cancer, bringing personalized medicine closer to fruition.

The test detects 7 common KRAS mutations that have proven clinical application with high sensitivity. It has the ability to detect between 0.8 to 6.4% mutation in a background of wild-type DNA. Approximately 30% of all colorectal metastatic cancers contain mutations in the KRAS gene. Those colorectal cancers with KRAS mutations do not respond to commonly used anti-EGFR drugs, and alternative treatments should be considered. This test would greatly reduce the delay of alternate treatment protocols for those patients who would not respond to the typical anti-EGFR drugs such as ERBITUX.

EpigenDx, an R&D contract service lab with expertise in genetic and epigenetic analysis, is now developing a series of genetic tests for molecular diagnostics. They will soon be releasing other genetic tests that will aid in treatment options for other cancers and advance personalized medicine.

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