Home » FDA Grants Breakthrough Designation to Datar’s Prostate Cancer Test
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.
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