New York State DOH grants RPCI approval to begin genomic testing of cancer patients

The New York State Department of Health (DOH) has granted Roswell Park Cancer Institute (RPCI) approval to begin genomic testing of cancer patients using its OmniSeq TargetTM advanced molecular diagnostic laboratory test.

The test, approved through the DOH's Clinical Laboratory Evaluation Program (CLEP), is part of a comprehensive approach developed by the RPCI Center for Personalized Medicine for profiling and interpreting the genetic information contained in the tumor tissue of cancer patients. OmniSeq TargetTM is one of only three tests approved for use in New York State that use next-generation sequencing, and it is the only assay to exclusively target actionable mutations — those alterations for which targeted therapeutic approaches exist.

OmniSeq TargetTM analyzes 23 different cancer-associated genes — such as ALK, EGFR, PTEN, KRAS and NRAS. Using multiple high-throughput genomic technologies OmniSeq TargetTM detects specific gene mutations, translocations and copy-number changes, looking for specific alterations and aberrations that indicate particular forms or targetable molecular characteristics of cancer. The test employs a dual sequencing platform for mutation testing, simultaneously using the Ion Torrent and Illumina sequencing platforms — an approach that has unparalleled sensitivity and positive predictive value compared to the typical single-platform model.

"This is a next-generation cancer test that's both comprehensive and focused, and there's no other test like it on the market," says Carl Morrison, MD, DVM, Executive Director of the Center for Personalized Medicine. "That focus on actionable mutations is what makes our approach unique and what makes this test such an important tool in therapeutic decision-making. When a physician gets our test results back, they will be able to apply that new information and adjust a patient's treatment plan to get them on the appropriate targeted therapy."

Roswell Park Cancer Institute has also developed a software system that delivers clinically relevant information from OmniSeq TargetTM testing into reports that become part of patients' electronic health records, enabling physicians to make more timely and informed treatment decisions. The comprehensive cancer center plans to incorporate OmniSeq TargetTM testing into the care of many patients starting in the third quarter of 2014.

"This test represents a major step forward in patient care," says RPCI President & CEO Donald L. Trump, MD. "For years, the promise of genomic medicine has been largely theoretical and prospective. OmniSeq TargetTM gives us the ability to identify, for many cancer patients, which therapy is going to be most effective for an individual, sparing patients from having to take a medication that was never going to work for them. We can expect dramatic improvements in both patient outcomes and quality of life."