Datar Cancer Genetics has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its blood test to diagnose brain tumours.
The liquid biopsy, dubbed TriNetra-Glio, is designed to diagnose brain tumours using only 15ml blood, where a conventional biopsy is not possible.
The test is indicated for patients to whom a brain biopsy is necessary, but cannot be performed as tumours are inoperable or inaccessible.
TriNetra-Glio is the third diagnostic test from the company to receive the Breakthrough Device Designation from the US FDA.
Datar has previously secured FDA Breakthrough Device Designations for liquid biopsies for early-stage detection of breast cancer and prostate cancer.
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.”
According to the company, diagnosis of brain tumours requires resources, associated with risk, and brain biopsies are difficult to perform in almost 40% of advanced cases.
Currently, there is no blood test available for the diagnosis of brain cancers, and doctors depend on complex surgical procedures for histopathological evaluation of tumour tissue.
Datar claimed that its TriNetra-Glio liquid biopsy is designed to detect circulating tumour cells (CTCs) released in the blood from the brain tumour, which is extremely rare.
A blinded study conducted at the Imperial College, London, showed that the TriNetra-Glio liquid biopsy detects brain tumours with high accuracy.
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.”
