Indigenously developed blood test to detect early breast cancer gets USFDA breakthrough status

Hyderabad: A Nashik-based cancer diagnostic research facility Datar Cancer Genetics has announced that US Food and Drug Administration (FDA) has granted ‘breakthrough designation’ for its blood test to detect early-stage breast cancer. The proprietary diagnostic test, developed by the cancer genetics research facility, can ‘detect Circulating Tumor Cells and Clusters specific to Breast Cancer with very high […]

Hyderabad: A Nashik-based cancer diagnostic research facility Datar Cancer Genetics has announced that US Food and Drug Administration (FDA) has granted ‘breakthrough designation’ for its blood test to detect early-stage breast cancer. The proprietary diagnostic test, developed by the cancer genetics research facility, can ‘detect Circulating Tumor Cells and Clusters specific to Breast Cancer with very high accuracy’.

‘Data from clinical trials has shown that the test can detect Stage 0 (earliest stage of cancer) and stage 1 breast cancers with accuracy of better than 99 percent without any false positives. The test has been validated on more than 20,000 women comprising healthy and cancer patients. The test requires only 5 ml blood and does not involve exposure to any radiation or discomfort associated with mammography,” Datar Cancer Genetics in a release said.

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“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. We are pleased with the recognition by the US FDA of our test as a breakthrough technology. It underscores the potential of the test which we believe will revolutionize the early detection and cure of breast cancer,” Rajan Datar, Chairman, Datar Cancer Genetics, said.

The diagnostic test is already available in Europe and is CE marked, which means that it complies with all the regulatory legislations that are prevalent in the European Union (EU).  The test will be available in India shortly as ‘EasyCheck’ and will be reasonably priced. The company is in discussions with several leading healthcare providers for ready accessibility.  

The company has also validated a blood test to detect multiple cancers including several extremely lethal malignancies such as Lung, Pancreas and Ovaries and will be available next year. 

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