FDA Grants Breakthrough for Early-Stage Breast Cancer

FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics

TriNetra is a Circulating Tumor Cell detection blood test which is able to identify early-stage Breast Cancer with high accuracy in women above the age of 40 years.
Datar Cancer Genetics Inc, a leading cancer research company focussed on early detection of cancers today 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. The Breakthrough Designation is granted by the FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The objective of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices granted such designation by expedited development, assessment, and review.