STATEMENT: FDA Grants Breakthrough Designation to Blood Test to Diagnose Brain Tumors

(Information sent by the signatory company).

STATEMENT: FDA Grants Breakthrough Designation to Blood Test to Diagnose Brain Tumors

(Information sent by the signatory company)

-US FDA grants breakthrough designation to blood test that helps diagnose inaccessible brain tumors

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

A prospective, blinded study by a research team from Imperial College London demonstrated high accuracy in detecting malignant brain tumors.

Datar Cancer Genetics already has three Breakthrough Device Designations granted by the US FDA, including liquid biopsies for the detection of breast and prostate cancer.

LONDON, Jan. 3, 2023 /PRNewswire/ -- Datar Cancer Genetics Inc today announced that the US Food and Drug Administration (FDA) has granted "breakthrough device" designation to its TriNetra™-Glio, a blood test that helps diagnose brain tumors. This is the company's third test to receive breakthrough device designation from the FDA. The company's breast and prostate cancer screening tests became the first liquid biopsies to receive breakthrough device designation.

Worldwide, brain cancer is the 12th deadliest cancer, and each year more than 250,000 adults die from the disease. The diagnosis of brain tumors requires many resources and risks, and it is impossible to perform brain biopsies in almost 40% of advanced cases. Currently, there is no blood test to diagnose brain cancers, and clinicians have to resort to complex surgical procedures to obtain tumor tissue for histopathological evaluation. The TriNetra™-Glio liquid biopsy is intended to detect cells released into the blood by the brain tumor; these cells are extremely rare and difficult to detect.

A prospective, blinded study by a research team from Imperial College London showed that the test is highly accurate. The test requires 15 ml of blood and is indicated for patients in whom a brain biopsy, although necessary, cannot be performed or has not been successful.

"In my opinion, a non-invasive blood test that detects circulating tumor cells (CTCs) would help solve many of the problems associated with the complex diagnosis of brain tumors. As a surgeon working on other technologies to define the tumor and the border functional during surgery with a level of molecular precision and to shorten the diagnostic pathway that would inform surgeons, I find this technology of great interest.In particular, the intended indication to provide a liquid biopsy diagnosis from a simple analysis Testing blood when 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 innovative technology has true diagnostic utility by detecting cells rather than capturing molecular markers of disease, on which liquid biopsies have relied until now," said Dr. Kev in O'Neill, a consultant neurosurgeon, chair of the Brain Tumor Research Campaign and principal investigator of the Brain Tumor Research Charity's Center of Excellence at Imperial College London, who led the blinded study to evaluate the test.

"The breakthrough designation is recognition of the potential benefits of TriNetra™-Glio in the clinical setting. The test may help people in whom brain biopsy or surgical resection of the tumor is not possible due to location or other limitations. With our proprietary CTC detection and enrichment technology, it will be possible to diagnose inaccessible tumors with a safe and patient-friendly blood test," said Dr. Vineet Datta, CEO of the business. The test has previously received CE certification and is now available to patients as 'Trublood™-CNS'.

Breakthrough device designation is granted by the FDA after rigorous evaluation indicating a reasonable expectation of analytical and clinical success for devices that demonstrate potential for more effective diagnosis of life-threatening diseases, such as cancer. The Innovative Devices Program is intended to provide patients and healthcare professionals with timely access to medical devices and tests that have received such designation through a priority review that accelerates development and evaluation.

About Datar Cancer Genetics

Datar Cancer Genetics is a global cancer research and applications company that leads the development of non-invasive technologies to improve the detection, treatment and management of cancer. The company's state-of-the-art cancer research center is NABL, ISO, CAP and CLIA accredited. The company cares for cancer patients and suspected cases in the United Kingdom, the European Union, the United States, the GCC and India. The company has state-of-the-art cancer research facilities in the United States, the United Kingdom, and India.

Contact: Dr Vineet


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