Datar Cancer Genetics (DCG) has announced 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 tumours.
This is the third test from DCG to have received the Breakthrough Device Designation from the USFDA. The company’s early-stage breast and prostate cancer detection tests became the first liquid biopsies to receive the Breakthrough Device Designation.
Worldwide, brain cancer is the 12th most lethal cancer, and each year, more than 250,000 adults die due to the disease. Diagnosis of brain tumours is resource-intensive, risk-prone and brain biopsies are impossible to perform in almost 40% of advanced cases.
Presently, no blood test is available for diagnosing brain cancers and doctors have to rely on complex surgical procedures to obtain tumour tissue for histopathological evaluation. The TriNetra-Glio liquid biopsy is intended to detect the cells released in the blood from the brain tumour; these cells are extremely rare and hard to detect.
A prospective, blinded study by a research team at the Imperial College, London, showed the test to be highly accurate. The test requires 15ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful.