Datar Cancer Genetics’ Blood Test for Brain Tumors Gains Breakthrough Status

Datar Cancer Genetics was awarded U.S. Food and Drug Administration (FDA) breakthrough status for its TriNetra-Glio blood test to help diagnose brain tumors, the third test from the company to receive such a designation.
 
Presently there is no blood test to diagnose brain cancers, and doctors must use complex surgical procedures to obtain tumor tissue for evaluation. TriNetra-Glio liquid biopsy aims to detect cells released in the blood from the brain tumor, which are very rare and hard to spot.
 
A study by an Imperial College London research team showed the test to be “highly accurate.” The test requires 15 ml of blood and is indicated for patients where a necessary brain biopsy can’t be done or has not succeeded.
 
“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. 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,” Dr. Kevin O’Neill, 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, told the press.
 
“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,” added Dr. Vineet Datta, executive director of the company. The test has previously received CE certification and is already available to patients as ‘Trublood-CNS’. 
 
The company’s early-stage breast and prostate cancer tests were the first liquid biopsies to receive the breakthrough device designation.