FDA Grants Breakthrough Device Designation for Blood Test for Inaccessible Brain Tumors

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors, according to an announcement from Datar Cancer Genetics, Inc.1

The TriNetra-Glio liquid biopsy is intended to detect the cells released in the blood from the brain tumor, which are extremely rare and difficult to detect. TriNetra-Glio is indicated for patients with intracranial space-occupying lesions where a biopsy is unviable due to the inaccessibility of the tumor or a comorbidity, the refusal of the patient, or a non-diagnostic result from a biopsy. The company said the indication for use will eventually be expanded to include diagnosis of all patients with brain lesions.2

“A non-invasive blood test that detects circulating tumor cells 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,” Kevin O’Neill, BSc, MB, BS, consultant neurosurgeon, chairman of the Brain Tumor Research Campaign and principal investigator for the Brain Tumor Research Charity’s Centre of Excellence, Imperial College, London, stated in a press release.

“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.”

Brain biopsies can be impossible to perform in approximately 40% of advanced cases. Additionally, nearly 70% of patients with intracranial lesions who receive a biopsy have benign conditions, and up to 20% of biopsies are non-diagnostic.2

Circulating glial cells (CGCs) are detectable in peripheral blood of patients with glial malignancies. A prospective study evaluated the ability of TriNetra-Glio to detect CGCs to determine its clinical sensitivity and specificity.3

Blood specimens from 68 patients with radiologically evident intracranial space-occupying lesion suspected of glial malignancies were blindly evaluated for the presence of CGCs. In the prospective study, 56 were positive for CGCs, and 12 were negative for CGCs. All CGC-positive specimens were confirmed glial malignancies, and all CGC-negative specimens were benign central nervous system (CNS) conditions.

Additionally, a case-controlled study included blood from 189 patients split into discrete training and test sets, including 145 patients with glioblastoma multiforme and 44 patients with benign CNS conditions. A second case-controlled study featured 40 patients with glial malignancies, 22 patients with benign CNS conditions, 24 patients with solid tumors with brain metastases, and 500 healthy individuals with no prior diagnosis of cancer and no current suspicion of cancer. A 98% rate of sensitivity and specificity was observed in detecting glial malignancies and differentiating them from benign CNS conditions in both case controlled studies.


  1. US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumors. News release. Datar Cancer Genetics, Inc. January 2, 2023. Accessed January 4, 2023. https://bit.ly/3GiymbT
  2. Press kit (USA). Datar Cancer Genetics, Inc. Accessed January 4, 2023. https://bit.ly/3X0RZM8
  3. Anichini G, Fulmali P, O'Neill K, et al. Path-24. Accurate identification of glial malignancies from peripheral blood. Neuro-Oncology. 2022;24(suppl 7):vii155. doi:10.1093/neuonc/noac209.597
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