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US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors


The liquid biopsy has been developed by Datar Cancer Genetics to help diagnose brain tumors where a conventional biopsy is not possible. 

A prospective, blinded study by a research team at the Imperial College, London showed very high accuracy in detecting malignant brain tumors.

Datar Cancer Genetics now has three Breakthrough Designations granted by the USFDA, including liquid biopsies for breast and prostate cancer detection.

MUMBAI, India , Jan. 2, 2023 /PRNewswire/ — Datar Cancer Genetics announced today that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ for its ‘TriNetra-Glio’, a blood test to help in the diagnosis of brain tumors. This is the third test from the Company to have received the Breakthrough Device Designation from the US FDA. The Company’s early-stage breast and prostate cancer detection tests became the first liquid biopsies to receive the Breakthrough Device Designation.

Blood Test to Help Diagnose Inaccessible Brain Tumors

In India, brain cancer is the 10th most lethal cancer, and each year, more than 26,000 adults die due to the disease. Diagnosis of brain tumors is resource-intensive, risk-prone and brain biopsies are impossible to perform in almost 40% of advanced cases. Presently, there is no blood test worldwide for the diagnosis of brain cancers, and doctors have to rely on complex surgical procedures to obtain tumor tissue for histopathological evaluation. The TriNetra-Glio liquid biopsy is intended to detect the cells released in the blood from the brain tumor; these cells are extremely rare.

A prospective, blinded study by a research team at the Imperial College, London, showed the test to be highly accurate. The test requires 15 ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful. 

“In my opinion, a non-invasive blood test that detects circulating tumor cells (CTCs) 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. In particular, 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,” said Dr. Kevin O’Neill, Consultant Neurosurgeon, Chairman of the Brain Tumor Research Campaign and Principal Investigator for the Brain Tumor Research Charity’s Centre of Excellence working at the Imperial College, London, who led the blinded study to evaluate the test.

“The clinical study data is indeed very impressive. This is the third and the most significant ‘breakthrough’ test from Datar Cancer Genetics up until now. This has the capacity to change clinical practice and help patients with difficult-to-access brain tumors immensely. It is a very proud moment for Indian science and a landmark achievement for cancer research globally,” said Dr. Sewanti Limaye, Director Medical & Precision Oncology and Director Oncology Research, Sir HN Reliance Foundation Hospital, Mumbai.

Dr. Darshana Patil, Medical Director of the Company commented that 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 tumors without any attendant risk. The test has previously received CE certification in Europe,” she said. 

The Breakthrough Designation is granted by the FDA after rigorous evaluation indicating a reasonable expectation of analytical and clinical success for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical tests and devices granted such designation by prioritized review to expedite development and assessment.

About Datar Cancer Genetics

Datar Cancer Genetics is a global oncology research and applications company that is spearheading the development of non-invasive technologies for improved detection, treatment and management of cancer. The Company’s state-of-the-art cancer research centre is NABL, ISO, CAP and CLIA accredited. The Company serves cancer patients and suspected cases in the UK, European Union, United States, GCC, and India. The Company has modern cancer research facilities in India, the UK and the US. 


Dr. Darshana Patil


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