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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