BALTIMORE, June 14, 2017 /PRNewswire/ -- Personal Genome Diagnostics Inc. (PGDx) today announced an agreement with the U.S. Department of Veterans Affairs (VA) to provide its PlasmaSELECT™ 64 liquid biopsy profiling assay to advanced cancer patients receiving treatment at VA facilities. This is the first plasma-based genomic profiling test to be offered to VA cancer patients and the first to also include testing for microsatellite instability (MSI), an important biomarker for determining whether certain immuno-oncology therapies might be an effective option. The new agreement expands on the company's existing contract with the VA, which provides for cancer genomic testing with PGDx's tissue-based CancerSELECT® 125 assay.
Doug Ward, Chief Executive Officer of PGDx, noted, "Following on the recent expansion of our contract with the VA to provide tissue-based cancer genomic testing, we welcome the VA's decision to add our plasma-based liquid biopsy panel as an option for patients with advanced cancer. By eliminating the need for tissue samples, PlasmaSELECT enables tumor profiling at any stage of the disease, enabling oncologists to make more informed treatment decisions by tracking changes in tumor DNA as therapy proceeds. Importantly, the assay is also the first liquid biopsy panel to include testing for MSI, the focus of the recent FDA accelerated approval for Merck's immuno-oncology agent Keytruda®, which is the first cancer drug approval based on a biomarker rather than the tumor's location in the body."
PlasmaSELECT analyzes circulating tumor DNA 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. 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.
Tumors that display MSI have lost the ability to repair errors in their DNA as a result of a condition known as mismatch repair deficiency (MMR). Researchers have shown that tumors displaying MMR deficiency and MSI are more susceptible to successful treatment with Keytruda (pembrolizumab) and other immuno-oncology drugs. MSI tumors have been identified in colorectal, endometrial, gastric and other types of cancer.
PGDx offers a complete range of cancer genome analysis tools, including exome and targeted approaches for tissue specimens, targeted approaches for plasma samples and a variety of custom tissue and plasma-based options designed to address the specific research needs of cancer researchers and drug developers. PGDx's service offerings for researchers and testing labs are complemented by the clinical services it provides through its CLIA-certified laboratory.
About Personal Genome Diagnostics .
Personal Genome Diagnostics (PGDx) is empowering the fight against cancer by unlocking actionable information from the genome for oncology researchers, drug developers, clinicians and patients. The expert team at PGDx draws on a deep understanding of cancer biology, extensive experience in cancer genomics and clinical oncology, and the company's distinctive technologies that precisely identify and characterize unique genomic alterations in tumors. PGDx is working toward broad patient access to its genomic technologies and products, through a CLIA-certified facility providing comprehensive genomic services, as well as a portfolio of regulated tissue-based and liquid biopsy genomic testing products for laboratories worldwide. Privately-held PGDx is headquartered in Baltimore, MD. For additional information, visit PersonalGenome.com.
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SOURCE Personal Genome Diagnostics Inc.