The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Datar Cancer Genetics’ 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.

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, according to the company. The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician’s prescription.

In the United States, more than 250,000 women are detected with breast cancer each year and early detection is considered critical for cure.

“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,” says Vineet Datta, MD FRCP, FRCP, MRCEM, FIMSA, executive director of the Datar Cancer Genetics.

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. 

The test is already available in Europe and is CE marked.

Featured Image: Blood test to detect early-stage Breast Cancer. Photo: Datar Cancer Genetics