VA Agrees to Use Second PGDx Cancer Assay for Patient Testing

Personal Genome Diagnostics said today it won a contract from the U.S. Department of Veterans Affairs (VA) to provide its PlasmaSELECT^™ 64 liquid biopsy profiling assay to advanced cancer patients being treated at VA facilities.

The value of the contract was not disclosed.

PlasmaSELECT will be the first plasma-based genomic profiling test to be offered to VA cancer patients—as well as the first to also include testing for microsatellite instability (MSI), a biomarker used in determining whether some immuno-oncology therapies might prove effective for those patients.

PlasmaSELECT is designed to analyze circulating tumor DNA (ctDNA) for genetic alterations, eliminating the need for tumor tissue or an invasive biopsy. The assay evaluates a targeted panel of 64 well-characterized cancer genes, using cell-free DNA extracted from plasma and prepared using proprietary methods that accommodate low abundance sample DNA.

According to PGDx, samples are processed using a proprietary capture process and high coverage next-generation sequencing that make it possible to identify tumor-specific sequence mutations, amplifications, translocations and microsatellite instability with high sensitivity and specificity.

By eliminating the need for tissue samples, PGDx says, PlasmaSELECT enables tumor profiling at any stage of the disease, and allows oncologists to track changes in tumor DNA as therapy proceeds, thus allowing them to make better informed treatment decisions.

PlasmaSELECT is also the first liquid biopsy panel to include testing for MSI. Last month, the FDA granted accelerated approval for Merck’s anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody Keytruda^® (pembrolizumab) in a new indication, as a treatment for pediatric and adult patients with unresectable or metastatic MSI-high (MSI-H) or mismatch repair solid tumors.

The approval marked the first time that the FDA approved a cancer drug based on a biomarker rather than the tumor's location in the body.

Tumors displaying mismatch repair (MMR) deficiency and MSI are more susceptible to successful treatment with Keytruda and other immuno-oncology drugs, PGDx said. MSI tumors have been identified in colorectal, endometrial, gastric and other types of cancer.

PGDx’s new agreement will expand on an existing contract with the VA announced in December 2016, in which the company is supplying its tissue-based CancerSELECT^® 125 assay for use in cancer genomic testing of patients.

CancerSELECT 125 analyzes the regions of a targeted panel of 125 well-characterized cancer genes, with the goal of identifying tumor-specific clinically actionable and functionally important sequence mutations, amplifications, structural rearrangements and other alterations in tissue across multiple cancer types.

Using Illumina next-generation sequencing technology, the test analyzes sample types that include frozen tumor or FFPE, cell lines, blood, saliva, and xenograft. CancerSELECT studies the coding regions of 117 genes and selected regions of 41 genes. The genes are intended to aid in treatment decision-making, and include both likely and known regions associated with drug sensitivity and acquired drug resistance.

“We welcome the VA's decision to add our plasma-based liquid biopsy panel as an option for patients with advanced cancer,” PGDx CEO Doug Ward said in a statement.