Oncology diagnostics developer Datar Cancer Genetics has secured breakthrough designation from the U.S. Food and Drug Administration (FDA) for its early-stage prostate cancer blood test.
TriNetra-Prostate identifies early-stage prostate cancer in men between the ages of 55 and 69 with more than 99% accuracy, the company said. It requires 5 ml of blood and is indicated for men with a serum prostate-specific antigen (PSA) measure of 3 ng/mL or higher, according to Datar.
