FDA Grants Designation For Early-Stage Breast Cancer Blood Test

FDA recently granted breakthrough device designation for Datar Cancer Genetics’ blood test to detect early-stage breast cancer.

The test, TriNetra, uses proprietary technology to detect Circulating Tumor Cells (CTCs) specific to breast cancer. In previous studies, the device detected Stage 0 and Stage 1 cancers with high accuracy. 

Specifically, TriNetra is approved for asymptomatic women over the age of 40 with a physician’s prescription. So far, the test was validated on over 20,000 women comprising healthy and cancer patients. 

“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,” Vineet Datta, MD, executive director of Datar Cancer Genetics, said in the announcement.

“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,” Datta continued. 

In the US, over 250,000 women are detected with breast cancer annually. Early detection of the disease is vital for a cure, as early-stage cancers are easier to treat than later-stage cancers and the survival rate is also higher.  

Previous studies have shown that women who have routine mammograms have a 10- to 25 percent lower chance of dying of breast cancer than women who do not have mammograms.

But TriNetra only requires five milliliters of blood and does not involve any exposure to radiation or discomfort associated with mammography. 

“This is for the first time that women above the age of 40 can obtain a breast cancer-specific blood test in consultation with their physician from the convenience and privacy of their home or office,” Rajan Datar, chairman of Datar Cancer Genetics, said in an official statement. 

So far, TriNetra is available in Europe and will be available in India in the coming weeks. Datar Cancer Genetics said it was in discussions with several leading healthcare providers for ready accessibility. 

The test is validated to detect multiple other cancers, including lung, pancreas, and ovarian cancer. The test will be available for those indications next year.