Personal Genome Diagnostics (PGDx), Baltimore, has received FDA clearance for its Elio tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.
“Nearly 80% of patients aren’t getting the clinical insights they need to inform their treatment path, or they aren’t being tested in a window of time that makes a difference in determining their care,” says Megan Bailey, chief executive officer of PGDx. “PGDx Elio tissue complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers. “Since the founding of our company, we have been united in our mission to empower the fight against cancer, and an integral part of that is establishing standardized testing as a core element of patient care.” adds Bailey. “Today is an incredible milestone for us, but more importantly for the millions of people living with cancer.” PGDx Elio tissue complete detects single-nucleotide variants and small insertions and deletions (indels) in more than 500 genes; select amplifications and translocations; and genomic signatures, including microsatellite instability and tumor mutation burden. Information from the diagnostic kit is intended for use by healthcare professionals to help tailor clinical management for patients based on their tumor’s unique genomic profile in accordance with professional guidelines. The broad genomic profiling assay includes biomarkers to help inform the use of targeted cancer therapies and immunotherapies and can help oncologists identify patients for clinical trial participation. “There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform,” says Pranil Chandra, DO, FCAP, FASCP, chief medical officer for genomic and clinical pathology services at PathGroup, an early collaborator for PGDx Elio tissue complete. “With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers. PGDx Elio testing features automated bioinformatics that ensures consistent results and quality of testing, resulting in fast and reliable clinical insights to enable oncologists to match patients with the best therapies to fight their cancer.” For more information, visit Personal Genome Diagnostics.