A simple blood test was able to accurately detect glial tumors, giving it the potential to lead to a faster diagnosis for patients with suspected high-grade gliomas, including GBM, astrocytomas, and oligodendrogliomas. 

“This has the capacity to change clinical practice and help patients with difficult-to-access brain tumors immensely,” said study author and oncologist Sewanti Limaye, MBBS, MD, in a news release.

PR Newswire. US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumors. January 2, 2023.

A first-of-its-kind test

In a news release from Imperial College London, study author Nelofer Syed, PhD, explained that “a non-invasive, inexpensive method for the early detection of brain tumors is critical for improvements in patient care.”

Imperial College London. Imperial research breakthrough could spare brain cancer patients risky surgery. January 26, 2024.

Biopsies are impossible for almost 40% of advanced brain cancer cases, due to location or risk factors. 

“Through this technology, a diagnosis of inaccessible tumors can become possible through a risk-free and patient-friendly blood test,” Dr. Syed said, noting that the blood test represents a “world-first,” as no other non-invasive or non-radiological tests currently exist for these types of tumors. 

TriNetra-Glio liquid biopsy

The study was funded by Datar Cancer Genetics, developers of the TriNetra-Glio test. The test has not yet been approved by the FDA, although it received FDA breakthrough device designation in 2023, and is expected to become available for clinical use within 2 years.

Speaking at Imperial College London’s news release, lead author and neurosurgeon Kevin O’Neill, MBBS, said that the test “is not just an indicator of disease, it is a truly diagnostic liquid biopsy. It detects intact circulating tumor cells from the blood, which can be analyzed to the same cellular detail as an actual tissue sample.”

Clinical validation study

Real-world performance of the blood test was validated in four ongoing clinical trials, using peripheral blood from all participants. The researchers assessed the ability of the blood test to detect and differentiate glial malignancies from non-malignant brain tumors, brain metastases from primary epithelial malignancies, and healthy donors. The precision of the blood test remained unaffected by common drugs and serum factors. Across the four trials, the test showed 100% specificity and 99.35% sensitivity. 

This [test] could help speed up diagnosis, enabling surgeons to apply tailored treatments based on that biopsy to increase patients’ chances of survival.

Impact on treatment decisions

TriNetra-Glio’s breakthrough device designation underscores its promising trajectory. And integrating genomic insights from initiatives like the 100,000 Genomes Project enhances personalized treatment strategies for patients with cancer, potentially improving outcomes.

In this initiative, whole-genome sequencing data were obtained from 13,880 solid tumors covering 33 cancer types and then linked with longitudinal treatment and outcomes data. An analysis of the data was published in Nature Medicine, focusing on clinically actionable genes.

Sosinsky A, Ambrose J, Cross W, et al. Insights for precision oncology from the integration of genomic and clinical data of 13,880 tumors from the 100,000 Genomes Cancer Programme. Nat Med. 2024;30(1):279–289.

Among other findings, most GBM cases had genetic mutations that had the potential to affect treatment decisions. Specifically, 94% presented with small genetic variants, while 58% showed copy number aberrations in one gene or more.

“We note that the clinical actionability of these mutations will be dependent on the individual case and clinical circumstances, such as the stage of the tumor and associated comorbidities of the participant,” the Nature Medicine authors wrote.