www.fdanews.com/articles/205472-datar-breast-cancer-blood-test-named-a-breakthrough-device
Datar Breast Cancer Blood Test Named a Breakthrough Device
November 23, 2021
Datar Cancer Genetics has been granted the FDA’s breakthrough device designation for its TriNetra blood test to detect early-stage breast cancer.
The test uses a proprietary technology developed by the Boston-based company to detect circulating tumor cells specific to breast cancer. Studies have shown that the test can detect even stage 0 and 1 cancer with high accuracy, the company said.
The prescription-only test, which is indicated for asymptomatic women over 40, has already received CE mark certification.