- Liquid biopsy was developed by Datar Cancer Genetics to help diagnose brain tumors where a conventional biopsy cannot be done.
- A blinded prospective study by a research team at Imperial College, London It showed very high accuracy in detecting malignant brain tumors.
- Datar Cancer Genetics now has three breakthrough classifications granted by the USFDA, including liquid biopsies for breast and prostate cancer detection.
Datar Cancer Genetics Inc. announced today that the US Food and Drug Administration (FDA) has granted a “Breakthrough Device Designation” to “TriNetra™ -Glio,” a blood test to aid in the diagnosis of brain tumors. This is the third test from the company that has received Breakthrough Device designation from the US Food and Drug Administration. The company’s early-stage breast and prostate cancer detection tests became the first liquid biopsies to earn a breakthrough device designation.
Worldwide, brain cancer is 12The tenth It is the most deadly type of cancer, and each year more than 250,000 adults die from the disease. The diagnosis of brain tumors is resource intensive and risky and brain biopsies are impossible to perform in approximately 40% of advanced cases. Currently, there is no blood test available to diagnose brain cancers, and doctors have to rely on complex surgical procedures to obtain tumor tissue for histopathological evaluation. TriNetra™– Glio liquid biopsy aimed at detecting cells released into the blood from a brain tumor; These cells are extremely rare and hard to detect.
A blinded prospective study by a research team at Imperial College, London, show that the test is very accurate. The test requires 15 mL of blood and is used for patients for whom 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) will help address many of the problems associated with diagnosing complex brain tumors. As a surgeon I am working on other techniques to define tumor and functional boundaries during surgery to a molecular level of accuracy and to shorten the path to diagnosis that Would inform surgeons, I find this technology to be of great interest.In particular, the intended reference to provide a liquid biopsy diagnosis from a simple blood test where tumors are considered inoperable or inaccessible would really address an unmet clinical need.I have found this test to be sensitive This advanced technology has real diagnostic utility by detecting cells rather than capturing molecular indicators of disease, on which liquid biopsies have until now relied. Kevin O’NealConsultant Neurosurgeon, Head of the Brain Tumor Research Campaign and Principal Investigator of the Brain Tumor Research Foundation’s Charitable Center of Excellence at Imperial College, LondonWho led the blind study to evaluate the test.
The breakthrough designation is an acknowledgment of the potential benefits of TriNetra™-Glio in the clinical setting. The test can help people in cases where a brain biopsy or surgical removal of a tumor is not possible due to the location of the tumor or other limitations. With our CTC enrichment and detection technology, the diagnosis of otherwise inaccessible tumors will be made possible with a risk-free, patient-friendly blood test.” Vineet DataThe company’s executive director. The test has previously been CE certified and is already available to patients as ‘Trublood™ -CNS’.
The breakthrough designation is granted by the US Food and Drug Administration (FDA) after rigorous evaluation indicating a reasonable expectation of analytical and clinical success for devices that show potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices program aims to provide patients and health care providers with timely access to medical tests and devices awarded this designation through priority review to accelerate development and evaluation.
About Cancer Genetics Datar
Datar Cancer Genetics is a global oncology research and applications company driving the development of non-invasive technologies to improve the detection, treatment and management of cancer. The company’s cutting-edge cancer research center is NABL, ISO, CAP and CLIA accredited. The company serves cancer patients and suspected cases in the United Kingdom and the European Union, United StateAnd GCC and India. The company has state-of-the-art cancer research facilities in the US, UK and India.
The source is Cancer Genetics Datar
