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


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Datar Cancer Genetics Inc., a global company developing blood-based diagnostics for cancer, has received the U.S. Food and Drug Administration’s breakthrough devices designation for TriNetra-Glio, the company’s non-invasive test to help diagnose brain tumors.

This is the company’s third breakthrough device designation. The FDA grants breakthrough designations for devices that demonstrate potential for more-effective diagnosis of life-threatening diseases. The program aims to provide patients and health care providers with timely access to devices.

The company’s first two designations were for early-stage breast cancer and prostate cancer detection tests—the first liquid biopsies granted the FDA designation, the company said. Liquid biopsies are fluid samples from patients versus tumor tissues that have been surgically removed. The Datar liquid biopsies use small samples of patients’ blood to look for tiny, rare cells released by cancerous tumors into the blood, known as circulating tumor cells, or CTCs.

“This latest 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,” said Datar Executive Director Vineet Datta, M.D. The company says with its proprietary CTC-enrichment and detection technology, a diagnosis of otherwise inaccessible cancers will become possible through a low-risk and patient-friendly blood test.

The American Cancer Society estimated more than 18,000 adults would die of brain and central nervous system cancers in 2022. Datta noted diagnosis of brain cancers is risk-prone and brain biopsies are impossible to perform in almost 40% of advanced cases. No blood test is available currently for diagnosing brain cancers, he added, and doctors must rely on complex surgical procedures to obtain tumor tissue to determine whether cancer is present.

With a new facility in Morrisville, Datar Cancer Genetics joins the state’s rapidly growing liquid-biopsy marketplace. “North Carolina has played a key role in the advancement of liquid biopsy-based screenings since the emergence of this promising technology,” said NCBiotech Vice President of Life Science Economic Development Laura Rowley, Ph.D. “The success of companies like Datar brings hope to patients worldwide and is a natural extension of our state’s exceptional research, medical, technology, and venture partnerships”

From its North Carolina facility, Datar plans to undertake necessary studies for market authorization by the FDA for TriNetra-Glio. The company already has advanced research and testing facilities in Guildford, United Kingdom, and Nashik, India.

More information is included in a news release recently distributed by the company.

Kathy Neal, NCBiotech Writer
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