Nashik firm gets US FDA’s ‘breakthrough designation’ for breast cancer detection blood test

The blood test, a first for detecting cancer in women over age 40 at home, uses a proprietary technology developed by Datar Cancer Genetics to detect circulating tumour cells with very high accuracy.

A Nashik-based cancer research company has announced that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Designation’ for its blood test to detect early-stage breast cancer.

The blood test uses proprietary technology developed by Datar Cancer Genetics to detect circulating tumour cells and clusters specific to breast cancer with very high accuracy. Data from clinical trials has shown that the test can detect stage 0 (DCIS) and stage I breast cancers with accuracy of over 99 per cent without any false positives.

The test has been validated on more than 20,000 women comprising healthy and cancer patients. It requires only 5 ml blood and does not involve exposure to any radiation or discomfort associated with mammography.

In India, more than 1.7 lakh women are detected with breast cancer, mostly at stage III or IV, which makes the treatment toxic and expensive besides having minimal chances of success. If detected early, breast cancer can be cured in almost 99 per cent of the cases.

“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 for our test. It underscores the potential of the test which we believe will revolutionise the early detection and cure of this dreaded disease worldwide,” said Rajan Datar, chairman of the research firm.

“Moreover, it is a matter of great pride that our scientists and clinicians from India have put the country at the centre stage of global cancer research and this is an example of the Prime Minister’s ‘Atmanirbhar Bharat’ mission,” he added.

The test is already available in Europe and will be available in India shortly as ‘EasyCheck’ and it will be reasonably priced. The company is in discussions with several leading healthcare providers for ready accessibility.

The firm has also validated a blood test to detect multiple cancers, including several extremely lethal malignancies, such as in the lung, pancreas and ovaries. It will be available next year.

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