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.

Raleigh, NC /PRNewswire/ - Datar Cancer Genetics Inc 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.

In the United States, brain cancer is the 9^th most lethal cancer, and each year, more than 18,000 adults die due to the disease. Diagnosis of brain tumors is risk-prone and brain biopsies are impossible to perform in almost 40% of advanced cases. Presently, no blood test is available for diagnosing 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 and hard to detect.

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 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 CTC-enrichment and detection technology, a diagnosis of inaccessible tumors will become possible through a risk-free and patient-friendly blood test," said Dr Vineet Datta, Executive Director of the Company. The test has previously received CE certification and is already available to patients as 'Trublood^™-CNS'.

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
With its newly set up facility in Raleigh, North Carolina, Datar will undertake necessary studies for market authorization by the FDA for TriNetra™-Glio. The Company is also pursuing cutting-edge research for validating multi-analyte approach-based precision treatment options and Circulating Tumor Cell research for early detection of cancer, non-invasive diagnostics, and therapy management. Datar is validating several diagnostic, theranostic and early detection assays, which will be offered as Laboratory Developed Tests (LDTs) in early 2023. Datar serves cancer patients and suspected cases in the UK, European Union, GCC, and India. The Company already has advanced research and testing facility at Guildford, UK, and Nasik, India. Datar's state-of-the-art facilities have national and international accreditations from quality certifying bodies.

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