US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors (PRNewswire)
"Datar Cancer Genetics Inc announced today that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra-Glio', a blood test to help in the diagnosis of brain tumors. This is the third test from the Company to have received the Breakthrough Device Designation from the US FDA. The Company's early-stage breast and prostate cancer detection tests became the first liquid biopsies to receive the Breakthrough Device Designation....A prospective, blinded study by a research team at the Imperial College, London, showed the test to be highly accurate. The test requires 15 ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful."