Datar wins FDA breakthrough nod for brain tumor-detecting blood test

[Image courtesy of Datar Cancer Genetics]Datar Cancer Genetics announced that it received FDA breakthrough device designation for its TriNetra-Glio blood test.

TriNetra-Glio aids in the diagnosis of brain tumors. It represents the third test from Datar to receive the FDA’s breakthrough device designation. The test joins Datar’s early-stage breast and prostate cancer detection tests.

According to a news release, the liquid biopsy detects cells released in the blood from the brain tumor. Datar said these cells are “extremely rare and hard to detect.” It requires 15 mL of blood. Its indication covers patients where a brain biopsy, although necessary, can’t be performed or proved unsuccessful.

“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…

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FDA grants breakthrough nod for Datar’s early-stage prostate cancer detection blood test

[Image from Datar Cancer Genetics]Datar Cancer Genetics announced today that it received FDA breakthrough device designation for its cancer-detecting blood test.

Boston-based Datar designed its TriNetra-Prostate blood test to detect early-stage prostate cancer. It follows the company’s early-stage breast cancer detection test, which garnered a breakthrough nod in November 2021.

The company said in a news release that studies show that TriNetra-Prostate can detect early-stage cancer with high accuracy (>99%) without any false positives. The test requires 5 mL of blood and has the indication for males of age 55-69 years with serum PSA of 3 ng/mL or higher.

Datar Cancer Genetics based its test upon the detection of prostate adenocarcinoma-specific Circulating Tumor Cells (CTCs) in the blood. The test already holds CE mark and is already available in Europe as “Trublood-Prostate.”

“The breakthrough device designation is a rec…

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