TriNetra-Glio aids in the diagnosis of brain tumors. It represents the third test from Datar to receive the FDA’s breakthrough device designation. The test joins Datar’s early-stage breast and prostate cancer detection tests.
According to a news release, the liquid biopsy detects cells released in the blood from the brain tumor. Datar said these cells are “extremely rare and hard to detect.” It requires 15 mL of blood. Its indication covers patients where a brain biopsy, although necessary, can’t be performed or proved unsuccessful.
“The breakthrough designation is a recognition of the potential benefits of TriNetra-Glio in the clinical setting. The test can help individuals where a brain biopsy or surgical resection of the tumor is not possible due to the location…