Breakthrough Device Designation for Diagnosis of Brain Tumors
A blood test called “TriNetra™-Glio” that aids in the detection of brain tumours has received "Breakthrough Device Designation" from the US Food and Drug Administration (FDA), according to a statement released by Datar Cancer Genetics.
The US FDA has designated this test, the third from the company, as a breakthrough device.
The first liquid biopsies to earn the Breakthrough Device Designation were the company's early-stage breast and prostate cancer detection tests.
Brain biopsies cannot be performed in nearly 40% of advanced instances of brain tumours, making diagnosis difficult and dangerous. Currently, there is no blood test available anywhere in the world to diagnose brain cancers, so physicians must perform difficult surgeries to remove tumour tissue for histopathological analysis.
The TriNetra™-Glio liquid biopsy is designed to find the exceedingly rare brain tumour cells released into the bloodstream.
The test, which requires 15 ml of blood, is recommended for patients in cases where a brain biopsy is required but either cannot be done or has been unsuccessful.