Non-Invasive Blood Test for Brain Cancer Acquires Breakthrough Device Designation From FDA

The FDA granted a breakthrough device designation to the TriNetra^™-Glio liquid biopsy for the diagnosis of brain tumors, according to a press release from the makers of the test, Datar Cancer Genetics.¹

TriNetra^™-Glio detects rare circulating glial cells (CGCs) released in the peripheral blood from the brain tumor to aid diagnosis in patients for whom a brain biopsy is either impossible or unsuccessful. In a prospective, blinded study at the Imperial College, London, the test detected CGCs in 56 patients along with 12 samples that tested negative; all positive specimens were confirmed to be glial malignancies. Moreover, all 12 patients who tested negative had benign central nervous system (CNS) conditions.²

The test also demonstrated a 98% sensitivity and specificity in the detection of brain malignancies, and in differentiating between malignancies and benign CNS conditions, as seen in in 2 earlier case-controlled studies.

“In my opinion, a non-invasive blood test that detects circulating tumor cells would help to address many of the problems associated with complex brain tumor diagnosis,” study author Kevin O'Neill, MBBS, a consultant neurosurgeon, chairman of the Brain Tumor Research Campaign and principal investigator for the Brain Tumor Research Charity's Centre of Excellence at the Imperial College, London, said in the press release.¹ “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.”

The first case-controlled study assessed blood samples from 189 patients—145 with glioblastoma and 44 with benign CNS conditions; the second study assessed samples from 40 patients with glial malignancies, 22 with benign CNS conditions, 24 with solid tumors and brain metastases, and 500 individuals with no prior diagnosis or suspicion of cancer. Additionally, the third prospective study included 68 patients with radiologically evident intracranial space-occupying lesions suspected to be glial malignancies.

Each sample was assessed blindly for CGCs to evaluate TruBlood’s sensitivity and specificity.

TriNetra^™-Glio is a non-invasive method of diagnostic stratification for patients with suspicious but non-specific neurocognitive symptoms. The test had previously received CE certification in the European Union and was available to patients as Trublood^™-CNS.

The FDA’s breakthrough designation is granted following robust assessment that uncovers reasonable expectation of analytical and clinical success for devices deemed to have shown potential as a diagnostic tool. Additionally, the breakthrough device program intends to provide timely access to tests and devices with a prioritized review to accelerate development and assessment.

“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,” O’Neill said.

References

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://yhoo.it/3VJBanZ
2. Anichini G, Fulmali P, O’Neill K, Datta V, Crook T, Syed N. Accurate identification of glial malignancies from peripheral blood. Neuro-Oncology. 2022;24(7 suppl):vii155. doi:10.1093/neuonc/noac209.597