Selah Genomics announced this week that its PrecisionPath molecular test for cancer will begin sales internationally. The PrecisionPath Colon test, which helps physicians analyze a tumor’s genetic information, is the first slated for market, Selah said.
The PrecisionPath test allows oncologists to learn the DNA profile of a tumor and use that data to select the most appropriate drug for treatment. For longer than a year, Greenville Health System has been profiling data from patients willing to participate and creating a bio repository database, said Selah Genomics CEO Michael Bolick. This will be the first time that the information is used to guide treatment, he said.
The colon-specific test was chosen due to existing guidelines on how oncologists should use genetic information to treat advanced-stage colon cancer patients. This “clinical utility” is a factor in making the case for cost reimbursement from health insurers and Medicare, according to Selah.
Oncologists nationwide could submit tissue samples to Selah Genomics, where the DNA would be extracted and profiled using a sequencer at GHS’ Institute for Translational Oncology Research (ITOR). Selah has committed to a seven-day turnaround time for analysis for the $975 test. This affordable price point, coupled with the results time frame, will help the test attain broad adoption for clinicians in community-based cancer treatment.
“We are thrilled to have it priced low enough that everyone can have access to it,” said Bolick.
The technology was developed with ITOR, where Selah Genomics bases its research lab. The test is not subject to FDA approval because the lab is under the Clinical Laboratory Improvement Amendments (CLIA) through the Centers for Medicare and Medicaid Services and overseen by a medical director, Bolick said.
“Building on our recent announcement, which utilizes and leverages PrecisionPath Colon in a four-way collaboration to create personalized medicine decision support tools with GHS and industry partners Becton Dickinson and DecisionQ, we see an immediate opportunity to advance clinical care in ways that were only hoped for within the last decade,” Bolick said in a release.
This is the first technology to be released through the Greenville Health Research Development Corporation (RDC), which was created by GHS to help shepherd research and technology developments to the clinical setting. Revenue generated by the RDC will be routed into GHS’ research and education, according to RDC executive director Sam Konduros.
Selah Genomics is planning future release of tests for lung and breast cancer, among others. The molecular diagnostics company was founded in 2006 to commercialize technology licensed from Clemson University and is the U.S. subsidiary of UK-based EKF Diagnostics.
