Mumbai, November 19, 2021 – Datar Cancer Genetics, a leading cancer research company
today 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.
