Selah Genomics, Greenville, SC, a laboratory subsidiary of in vitro diagnostics manufacturer EKF Diagnostics, has partnered with Greenville Health Systems (GHS), a community-based cancer institute, to introduce a next-generation sequencing testing service for colon cancer called PrecisionPath Colon. The laboratory-developed panel test for invasive colon cancer is intended to help ordering physicians identify clinically actionable genetic mutations in patient samples.
PrecisionPath Colon assists in identifying the presence of mutations in 50 cancer-related genes from genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded tumor tissue. The test was developed to help physicians select the most effective options for a patient by identifying the individual’s tumor type and its specific susceptibility to available treatments. The panel test reports the mutation status of a number of actionable biomarkers, namely BRAF, EGFR, KIT, KRAS, NRAS, PDGFRA, and PI3KCA genes. It offers a turnaround time of less than 7 days per reportable result.
Under the collaboration, Selah will analyze and extract DNA from tumor samples. It will then perform molecular profiling at GHS’s Institute for Translational Oncology Research using sequencing methodology adapted from an assay by Life Technologies, Carlsbad, Calif, using an Ion Torrent sequencing platform. Following sequencing, the panel provides a concise report that differentiates genes with proven clinical utility and others under clinical investigation. The report is then made available to oncologists and patients through Selah’s secure Web portal. As the body of evidence for clinical utility grows, reports will be updated accordingly.
While PrecisionPath Colon will initially be available only through GHS’s oncology treatment centers, EKF is planning to expand the service throughout the United States. The company also intends to offer PrecisionPath panel testing for additional indications—including lung cancer, breast cancer, and melanoma—beginning in late 2015.
Offered at $975, the testing service aims to serve as an affordable option for customers. According to the company, competitive services are available in the market at a price of more than $5,000.
“The launch of PrecisionPath Colon at a price under $1,000, coupled with a 7-day turnaround time, demonstrates EKF’s commitment to providing affordable access to world-class diagnostic testing to oncologists treating patients across the United States,” says Julian Baines, chief executive of EKF. “It remains our goal to secure reimbursement for PrecisionPath from public and private payors, and we believe our case is strengthened by our focus on invasive colon cancer and the clear guidelines that support clinical utility in this area.”
The partnership between EKF and GHS is an extension of a relationship that began in March 2012, with the formation of Selah’s Clinical Genomics Center at GHS.
“We are excited by the opportunity to actively work with Selah to help standardize the availability of molecular medicine,” says Jeffrey Edenfield, MD, medical director of the GHS Institute for Translational Oncology Research. “Not everyone has a major academic cancer institute in their backyard, but everyone deserves access to a precise diagnosis and targeted treatment options.”
For more information, visit EKF Diagnostics.