Blood test for detecting difficult-to-access brain tumors receives breakthrough designation from the US FDA

Blood test for detecting difficult-to-access brain tumors receives breakthrough designation from the US FDA

Blood test for detecting difficult-to-access brain tumours receives breakthrough designation from the US FDA

Datar Cancer Genetics created the liquid biopsy to aid in the diagnosis of brain cancers when a traditional biopsy is not an option.

A research team at Imperial College, London, conducted a prospective, blinded investigation that demonstrated extremely high accuracy in identifying malignant brain tumours.

The USFDA has now given Datar Cancer Genetics three Breakthrough Designations, including those for liquid biopsies for the diagnosis of breast and prostate cancer.

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The US Food and Drug Administration (FDA) has designated Datar Cancer Genetics’ “TriNetraTM-Glio” blood test, which aids in the identification of brain tumours, as a “Breakthrough Device,” the company said today. The US FDA has designated this test as a breakthrough device for the third time by the company. The Company received the Breakthrough Device Designation for its early-stage breast and prostate cancer detection tests, making them the first liquid biopsies to do so.

More than 26,000 adults in India lose their lives to brain cancer each year, making it the tenth most deadly malignancy in the country. Brain biopsies cannot be performed in nearly 40% of advanced cases of brain tumours, making diagnosis difficult and dangerous. Currently, there is no blood test available anywhere in the world to diagnose brain tumours, thus surgeons must do difficult surgeries to remove tumour tissue for histological analysis. The TriNetraTM-Glio liquid biopsy is designed to find the exceedingly uncommon brain tumour cells released into the bloodstream.

The test was found to be quite accurate in a prospective, blinded investigation conducted by a research team at Imperial College, London. The test, which needs 15 ml of blood, is recommended for patients in cases where a brain biopsy is essential but either cannot be done or has been ineffective.

“In my view, a non-invasive blood test that finds circulating tumour cells (CTCs) will aid in resolving a lot of the issues related to difficult brain tumour diagnosis. I find this technique to be of great interest because as a surgeon working on other technologies to shorten the diagnostic pathway that would inform surgeons and to define the tumour and functioning boundaries during surgery to a molecular level of accuracy. It will specifically address an unmet clinical need to diagnose cancers that are thought inoperable or inaccessible using a liquid sample from a straightforward blood test.

This test is very sensitive and specific, in my experience. According to 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 at Imperial College, London, who oversaw the blinded study to assess the test, this ground-breaking 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.

“Indeed, the clinical study’s data are really impressive. The third and most important “breakthrough” test from Datar Cancer Genetics to date is this one. This has the potential to significantly improve clinical practise and benefit patients with difficult-to-access brain malignancies. It is a historic accomplishment for cancer research worldwide and a source of great pride for Indian science “the Sir HN Reliance Foundation Hospital in Mumbai’s Director Medical & Precision Oncology and Director Oncology Research, Dr. Sewanti Limaye.

The FDA’s designation of the test as a breakthrough represents a significant endorsement of the technology behind it, according to Dr. Darshana Patil, the company’s medical director. “The non-invasive test used to assist in the risk-free diagnosis of difficult cases of brain tumours is powered by our patented CTC-enrichment and detection technology. In Europe, the test has previously been CE-certified “explained she.

After a thorough assessment confirming a realistic prospect of analytical and clinical success for devices that demonstrate a potential for more effective diagnosis of life-threatening disorders like cancer, the FDA awards the Breakthrough Designation. In order to speed up research and evaluation, the Breakthrough Devices Program aims to give patients and healthcare professionals early access to medical tests and devices that have been given this designation.

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