FDA has granted the breakthrough device designation to Datar’s TriNetra Prostate Blood Test

TriNetra Prostate Blood test is developed to detect early-stage prostate cancer by a simple blood test without an invasive biopsy.   Circulating tumor cells are rare cells which are shed from the original tumor and enter the bloodstream.  The test is designed to collect and enrich circulating tumor cells in the blood, so that they can be used to diagnose prostate cancer for the individuals who have elevated levels of PSA or for those with suspicious findings on rectal exam.  According to two studies, TriNetra prostate Blood test can diagnose early-stage prostate cancer with almost 100 % accuracy without false positivity.  Thus, the test will make it possible to reduce the numbers of an invasive biopsy among those who have benign prostate conditions.  This test is already approved and readily available as TruBlood-prostate in Europe.

The FDA breakthrough designation is a process to expedite the development and review of drugs or devices which are intended to treat life-threatening diseases, so that patients can access life-saving treatments in a timely manner.