US FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed in India
It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years
Datar Cancer Genetics, a leading 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 a proprietary technology developed by the company to 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 (DCIS) and Stage 1 Breast Cancers with accuracy of better than 99% 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.
In India more than 1.7 lac women are detected with Breast Cancer, mostly at stage III or IV which makes the treatment toxic and expensive besides minimal chances of success. If detected early, Breast Cancer can be cured in almost 99% 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 of our test as a breakthrough technology which is a momentous milestone. It underscores the potential of the test which we believe will revolutionize the early detection and cure of this dreaded disease worldwide. 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.” said Mr.Rajan Datar, Chairman of the Company.
The test is already available in Europe and is CE marked. 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.