The U.S. Food and Drug Administration (FDA) granted Datar Cancer Genetics Breakthrough Device Designation for its TriNetra-Glio test, a blood biopsy to help in the diagnosis of brain tumors.
This is the third test from the company to have received the Breakthrough Device Designation from the U.S. FDA. The company’s early-stage breast and prostate cancer detection tests previously received the Breakthrough Device Designation.
Each year, more than 250,000 adults die due to brain cancer. Diagnosis of brain tumors 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 tumor tissue for histopathological evaluation. The TriNetra-Glio liquid biopsy is intended to detect the cells released in the blood from the brain tumor; 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 15 ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful.
“In my opinion, a non-invasive blood test that detects circulating tumor cells (CTCs) would help to address many of the problems associated with complex brain tumor diagnosis,” says Kevin O’Neill, BSc, MB, BS, consultant Neurosurgeon, chairman of the Brain Tumor Research Campaign and Principal Investigator for the Brain Tumor Research Charity’s Centre of Excellence working at the Imperial College, London, who led the blinded study to evaluate the test. “As a surgeon working on other technologies to define the tumor and functional boundary during surgery to a molecular level of accuracy and to shorten the diagnostic pathway that would inform surgeons, I find this technology of significant interest. In particular, the intended indication to provide a liquid biopsy diagnosis from a simple blood test where tumors are deemed inoperable or inaccessible will truly address an unmet clinical need. I have found this test to be highly sensitive and specific. 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.”
The Breakthrough Designation is granted by the FDA after rigorous evaluation indicating a reasonable expectation of analytical and clinical success for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer.
“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. 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,” says Vineet Datta, MD, executive director of the company. The test has previously received CE certification and is already available to patients as Trublood-CNS.
The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical tests and devices granted such designation by prioritized review to expedite development and assessment.
