Datar Brain Cancer Liquid Biopsy Granted Breakthrough Status

The FDA has granted Breakthrough Device status to Datar Cancer Genetics’ TriNetra-Glio blood test to diagnose inoperable brain tumors.

The liquid biopsy, which detects tumor cells released into the bloodstream, is especially useful when the tumor is inaccessible, the company said.

There are currently no blood tests cleared by the FDA to diagnose brain cancer, however the TriNetra-Glio test has earned the CE mark and is available in Europe as Trublood-CNS.

The Breakthrough Device program gives expedited reviews of innovative tests and medical devices to provide more timely access for patients and healthcare providers.