By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Personal Genome Diagnostics’ CancerSelect targeted gene profiling panel has been selected for use in all newly-diagnosed lung cancer patients in the U.S. Department of Veterans Affairs (VA) New England Veteran’s Integrated Service Network (VISN 1).
Personal Genome Diagnostics (PGDx; Baltimore, Md.) says the VA contract is for $2 million of testing services over three years. While testing will initially be limited to newly-diagnosed non-small cell lung cancer patients in VISN 1, it is anticipated that the Precision Oncology Program (POP) will be expanded nationally in the VA system, pending regional success.
PGDx’s CancerSelect targeted gene panel detects alterations in 88 well-characterized genes of high clinical and biological importance. CancerSelect relies on high-coverage (500x) next-generation sequencing, followed by proprietary bioinformatics mutational analysis. The company says CancerSelect maintains high sensitivity and specificity at mutant allele frequencies as low as 2 percent. CancerSelect can identify tumor-specific mutations including copy number changes and rearrangements in the genes known to impact treatment decisions. Reported results include a list of possible treatment options specific for the genetic alterations found in the patient’s tumor, as well as therapies approved in other cancer types and clinical trials specific to the genetic alteration and/or tumor type.
VA’s newly-established POP program marks a joint-effort between clinical care and research in VISN 1. As part of the program it will provide routine molecular profiling for tumors of lung cancer patients that will both support personalized treatment (matching patients to research protocols or targeted therapies), and also advance discovery and validation of new cancer biomarkers. Program organizers hope this effort will build to a “larger initiative,” designed to increase access to cancer genomic testing, targeted therapies and clinical trials across the VA system.
PGDx has previously stated that the list price for CancerSelect is $5,850, although it declined to give any additional financial details related to the VA deal. The test is run on tumor and either blood or saliva samples in PGDx’s CLIA-certified laboratory with a turn-around-time of three weeks. The company tells G2 that they have “adequate infrastructure, facilities, and equipment to handle the increased volume from the VA work.” PGDx was spun out of Johns Hopkins University and was co-founded by Luis Diaz, M.D., and Victor Velculescu, M.D., Ph.D.