The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Datar Cancer Genetics’ new blood test, TriNetra-Glio, intended to help diagnose inaccessible brain tumours.
Using 15ml blood, the new liquid biopsy has been designed to diagnose brain tumours in cases where a conventional biopsy is not possible.
It is indicated for patients who require a brain biopsy, which either cannot be performed or has already been unsuccessful.
The TriNetra-Glio test is developed for identifying extremely rare cells that are released into the blood by a brain tumour.
A research team at Imperial College, London, UK, conducted a blinded, prospective study on the new liquid biopsy.
In the study, the TriNetra-Glio liquid biopsy showed high accuracy in detecting brain tumours.
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Datar Cancer Genetics medical director Dr 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.”
The company stated that TriNetra-Glio is its third diagnostic test to receive Breakthrough Device Designation from the US FDA.
It previously secured FDA Breakthrough Device Designations for its tests for early-stage detection of breast and prostate cancers.
According to Datar, diagnosis of brain tumours is risky and requires lots of resources. Furthermore, brain biopsies are difficult to perform in almost 40% of advanced cases.
Datar claimed that there is currently no blood test available for the diagnosis of brain cancers in the world, leaving doctors to depend on complex surgical procedures for histopathological evaluation of tumour tissue.