Nashik-Based Cancer Research Firm Gets US FDA Nod For Breast Cancer Detection Blood Test

The United States of America Food and Drug Administration ( FDA) has granted 'Breakthrough Designation' to a Nashik-based cancer research company for its breast cancer detection blood test.

The Datar Cancer Genetics has developed a blood test which uses propriety technology to detect circulating tumour cells and clusters specific to breast cancer with accuracy. The clinical trials data show that the test can detect stage 0 (DCIS) and stage 1 breast cancer with 99 per cent accuracy without false positives, as per a report by the Indian Express.

The trials were reportedly done on more than 20,000 women including both healthy and cancer patients. The test only requires five milliliter blood and does not expose the patients to any radiation or discomfort associated with mammography. According to the report, more than one lakh women in India are detected with breast mostly at third and fourth stage. The treatment after that gets toxic and expensive with minimum chances of success. Experts have said that breast cancer if detected early and cure 99 per cent cases.

The chairman of the research firm, Rajan Datar said, "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."
He added, “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."

The said test is already being used in Europe and will be shortly available in India as per reports. The blood test will be called EasyCheck and will not be expensive. 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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