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 recognition of the potential benefits of TriNetra-Prostate in the clinical setting,” Datar Executive Director Dr. Vineet Datta said in the release. “The test can help reduce the number of biopsies among individuals with benign conditions of the prostate and it can also improve detection rates among those who do have prostate cancer. With our proprietary CTC-enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer.”