FDA Grants Breakthrough Designation for TriNetra™-Glio to Detect Brain Tumors
A prospective, blinded study confirmed the accuracy of the detecting brain tumors with the TriNetraTM-Glio test, addressing an unmet medical need for experts in this space.
The FDA has granted breakthrough device designation for TriNetra™-Glio, a blood test to help diagnose patients with brain tumors, according to Datar Cancer Genetics, Inc.
In a prospective, blinded study performed by a research team at the Imperial College in London, investigators showed very high accuracy with the TriNetraTM-Glio test in detecting malignant brain tumors.
The test requires 15 ml blood and is indicated for patients where a conventional brain biopsy has been unsuccessful or cannot be performed.
"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 [circulating tumor cells]-enrichment and detection technology, a diagnosis of inaccessible tumors will become possible through a risk-free and patient-friendly blood test," said Vineet Datta, MD, executive director of the company, in the press release.
Diagnosing brain tumors is risky in almost 40% of advanced cases and requires many resources, forcing doctors to depend on complex surgical procedures for histopathological evaluation of tumor tissue.
According to Datar Cancer Genetics, Inc, there are currently no blood tests available to aid in the diagnosis of brain cancers, leaving experts with an unmet medical need.
Because of this, the TriNetra™-Glio liquid biopsy aims to detect rare and hard to detect cells that are released in the blood from the brain tumor. The study performed at the Imperial College confirmed the accuracy of the test.
This test has received previous CE certification, which is recognized in the European Union [EU] and other regions that accept the designation. Previously, the EU also confirmed the test's conformity with European standards. The test is currently available in the EU as Trublood-CNS.
This marks the third test from the company to have received the breakthrough designation from the FDA. The other 2 detection tests are for diagnosing early-stage breast and prostate cancer, each of which became the first liquid biopsies to receive the breakthrough device designation.
“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," added Kevin O'Neill, MD, consultant neurosurgeon, chairman of the Brain Tumor Research Campaign, principal investigator for the Brain Tumor Research Charity's Center of Excellence working at the Imperial College, London, who led the blinded study to evaluate the test, in the press release.
