Datar blood test receives FDA Breakthrough Designation

Datar Cancer Genetics has secured FDA Breakthrough Designation for their blood test used to detect inaccessible brain tumours, where traditional surgical biopsy is not possible.

According to the company, in almost 40% of advanced cases, brain biopsies are too difficult to perform due to inaccessibility. There are also a lot of risk factors to consider, as brain biopsies can be resource intensive and hard on the patient.

TriNetra-Glio is a liquid biopsy designed to diagnose brain tumours using only 15ml of blood. It is designed to detect circulating tumour cells (CTCs) released in the blood from the brain tumour.

A clinical trial study was held at The Imperial College, London, UK, to test the accuracy of TriNetra-Glio in biopsy-naïve adults with Intra-Cranial Space Occupying Lesions (ICSOLs). The test was found to have high clinical sensitivity (a very low risk of missing any primary glial malignancy) and high clinical specificity (little to no risk of false positives in individuals without a primary glial malignancy).

Datar Cancer Genetics medical director Darshana Patil said: “The breakthrough designation by the FDA is a landmark recognition of the technology behind the test. Our proprietary CTC-enrichment and detection technology powers the non-invasive test to help diagnose challenging cases of brain tumours without any attendant risk. The test has previously received CE certification in Europe.”

Blinded study principal investigator Kevin O’Neill said: “In my opinion, a non-invasive blood test that detects circulating tumour cells (CTCs) would help to address many of the problems associated with complex brain tumour diagnosis. As a surgeon working on other technologies to define the tumour 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. 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.”

James Spargo