The results of TriNetra™-Breast will be compared with the results of mammography and/or histopathology for performance estimation of the test. Study participants will be followed for clinical outcomes for maximum duration of 2 years.
"Datar Cancer Genetics...announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™' blood test to detect early-stage Breast Cancer...TriNetra™ uses a proprietary technology developed by the Company to detect Circulating Tumor Cells (CTCs) specific to Breast Cancer. Studies have shown that TriNetra™ can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy. The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician's prescription."