PGDx test gets ‘Breakthrough Device’ designation

Baltimore-based Personal Genome Diagnostics (PGDx) recently received a designation from federal regulators that’s designed to help allow patients to get quicker access to new devices.
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health granted a “Breakthrough Device” designation for one of the Johns Hopkins spinout’s new kinds of cancer tests, which combine genomic analysis and the use of algorithms to analyze data.
Known as PGDx elio plasma resolve, the test is a liquid biopsy, a new form of genomic testing which allows a sample to be taken for analysis without requiring surgery. Along with the materials to run a test, the product includes a server and software for data analysis, said PGDx Senior Marketing Manager KC McGrath.
The Breakthrough Device designation is designed to expedite regulatory approval of a medical device that provides a more effective treatment or diagnoses for a debilitating disease or condition. The PGDx was selected based on results that showed it may help patients who cannot provide tissue samples. A feature of the test could also help select patients for certain therapies.
If approved, the company indicated it could be the first liquid biopsy test that can be “kitted” and run in laboratories.
Being granted the status “shows there is an unmet clinical need that PGDx elio plasma resolve can help address, and we’re excited about the opportunity to impact more patients globally by enabling this test to be run locally,” McGrath said.
Canton-based PGDx closed on $75 million in Series B funding earlier this year, and opened a second location in Brewers Hill.