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# Prostate Cancer Blood Test Gets Breakthrough Status
- URL: https://www.fdaweb.com/prostate-cancer-blood-test-gets-breakthrough-status/
- Published: 2022-02-14T12:00:00.000Z
- Updated: 2026-09-14T17:32:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151149

FDA has granted Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer. The designation is based on studies showing that the test can detect early-stage cancer with high accuracy (greater than 99%) without any false positives, according to the company, adding that to process the test, it requires 5 ml blood and is based upon the detection of prostate adenocarcinoma-specific circulating tumor cells in the blood. The test is indicated for men aged 55-69 years with serum PSA of 3 ng/mL or higher.