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.
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