Datar Cancer Genetics announced today that it received FDA breakthrough device designation for its TriNetra blood test.
The company designed its TriNetra blood test to detect early-stage breast cancer using proprietary technology that detects circulating tumor cells (CTCs) specific to breast cancer.
According to a news release, TriNetra can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy, requiring just 5 mL of blood. Its indication covers asymptomatic women above the age of 40 with a physician’s prescription.
Datar’s test already holds CE mark and is available in Europe.
“We are pleased that the FDA has recognized the potential of TriNetra for the detection of early-stage breast cancer. We believe that TriNetra will offer definitive advantages for breast cancer screening once it receives marketing authorization from the FDA,” Datar Executive Director Dr. Vineet Datta said in the release. The company believes that detection of CTCs is the most dependable and accurate method for early detection of cancer as it enables capture and characterization of functional components of a tumor rather than fragments of dead cells. In that sense, CTCs represent a true non-invasive micro-biopsy.