FDA Grants Breakthrough Designation to Datar’s Prostate Cancer Test

Datar Cancer Genetics’ TriNetra-Prostate blood test to detect early-stage prostate cancer has received the FDA’s Breakthrough Device designation.

The test can detect early-stage cancer with greater than 99 percent accuracy, without any false positives, the company said, helping clinicians to decide whether it is necessary to take a biopsy for a confirmatory diagnosis.

The Boston, Mass.-based company previously received the FDA’s Breakthrough Device designation for its early-stage breast cancer detection test.