Datar wins FDA breakthrough nod for brain tumor-detecting blood test
03 Jan 2023
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 of the tumor or other constraints,” said Dr. Vineet Datta, Datar executive director. “With our proprietary CTC-enrichment and detection technology, a diagnosis of inaccessible tumors will become possible through a risk-free and patient-friendly blood test. The test has previously received CE certification and is already available to patients as ‘Trublood-CNS.'”
Dr. Kevin O’Neill led the blinded study to evaluate the Datar blood test. He serves as chair of the Brain Tumor Research Campaign. He also holds the role of principal investigator for the Brain Tumor Research Charity’s Centre of Excellence at the Imperial College, London.
O’Neill said this type of blood test helps to “address many of the problems associated with complex brain tumor diagnosis.”
“I have found this test to be highly sensitive and specific,” O’Neill said. “This breakthrough technology has true diagnostic utility by detecting cells rather than picking up molecular indicators of disease, which until now liquid biopsies have been based upon.”
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