GenPath, BioReference Labs to introduce OnkoMatch solid tumor genotype test

BioReference Laboratories, Inc. (NASDAQ: BRLI) and its GenPath Oncology business unit and through its exclusive commercialization agreement with the Massachusetts General Hospital (MGH) is introducing its groundbreaking solid tumor genotype test. The test - which will be marketed as OnkoMatch^TM - will help oncologists match patients with cancer therapies tailored to a particular genetic mutation driving the disease and potentially identify additional patients who might qualify for clinical trials. Beginning on January 23, 2012, OnkoMatch^TM will be available to community oncology practices and hospitals nationally through GenPath, making cutting edge technology accessible to patients around the country.

This is the first time a solid tumor genotyping test for cancer has been available nationally, combining the clinical and scientific expertise of Mass General with the efficiency, service and technical capabilities of GenPath. "Historically there has been a disconnect between academic research and the clinical options available to most patients. Through our commercialization agreement with MGH we have collaborated in key areas such as bioinformatics and clinical interpretation to increase tumor genotyping access nationally for patients. As drug companies continue to invest in personalized therapies, there is a need to identify more patients who could benefit from these advancements as well as bring hope to those who have simply run out of therapeutic options." said Marc D. Grodman, MD, President and CEO of BioReference Laboratories.

OnkoMatch^TM is specifically designed for solid tumor cancers such as lung, breast, colon, pancreas, thyroid and skin. From a single tissue specimen taken from the patient's tumor, the test will analyze 14 oncogenes, genes that drive cancer, across 68 mutational hot spots. "We used sophisticated DNA extraction and mutational analysis techniques developed at MGH's Translational Research Laboratory, based on a process called multiplex PCR" (polymerase chain reaction) technology," said John Iafrate, MD-PhD, Director of Molecular Pathology at Massachusetts General Hospital and Associate Professor at Harvard Medical School. "We can now extract DNA samples from extremely small tumor tissue samples, targeting many genes at once and accurately reporting the mutations that are being tested."

Tumor genotyping through OnkoMatch^TM will enable oncologists to match their patients with appropriate targeted therapy, either FDA approved or in a clinical trial setting. Often patients with advanced disease are refractory to currently approved therapies and as a result, investigational therapies are sought to induce a tumor response. GenPath will share with the oncologist links to clinical trials associated with detected mutations allowing them to quickly access information needed to enroll patients in an appropriate trial.

In comparison to other tumor genotyping assays, such as next-gen sequencing, OnkoMatch^TM is significantly less costly (<$1,000) and reported much more quickly. The turn-around time for OnkoMatch^TM is seven days - significantly faster than the standard 3-4 weeks for genotyping tests. "OnkoMatch^TM represents a seismic shift in cancer diagnostics. The test will enable oncologists to genetically profile a patient's tumor at a reasonable cost thus increasing patient access to novel therapies." said Dr. Grodman. OnkoMatch^TM is expected to be covered by all major insurance carriers.

"This kind of genotyping is going to become part of everyday care for cancer patients, and we are enthusiastic that GenPath will make it broadly available," noted Dr. Iafrate.