The US FDA grants the coveted Breakthrough Designation for Early-Stage Prostate Cancer Detection Blood Test Developed in India by Datar Cancer Genetics

MUMBAI  : Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Designation’ for its blood test to detect early-stage prostate cancer. This is the second test from Datar Cancer Genetics that has received the Breakthrough Device Designation from the US FDA. Late last year, Datar Cancer Genetics’ breast cancer detection test became the first such test to receive the designation.

This is the first blood test for men which can detect early-stage prostate cancer with high accuracy. The test is available in India by the name of Easycheck. Men with serum PSA of more than 3 ng / mL can avail of this test in consultation with their physician. The test requires 5 ml blood and does not involve exposure to radiation or any of the discomforts of a digital rectal examination. The blood test is based on the detection of Circulating Tumor Cells (CTCs) specific to prostate adenocarcinoma. The test can detect early-stage prostate cancers with more than 99% accuracy without any false positives. The test has been validated in large clinical studies involving healthy males and prostate cancer patients.

In India, about 35,000 men were detected with prostate cancer in 2020 and this number is slated to increase every year, as is the case for all cancers due to various risk factors. Unfortunately, most prostate cancer cases are detected at late stages (III or IV) where it has spread to other organs. In such cases, curative surgeries that can remove the cancerous tissue are not viable options, and treatment involves long-term administration of anticancer drugs to manage the disease. If detected at early stages where cancer has not spread out of the prostate, prostate cancer has a very high (>99%) chance of being cured.

“About 75% of prostate biopsies are benign and with foreknowledge, these could be potentially avoided. The new blood test by the Datar team will help Doctors decide precisely the patients who need a biopsy and who do not. This is a very significant scientific advancement in the complex field of liquid biopsies coming from India. I congratulate the Datar team for their exemplary work and achievement,” said Dr. Sewanti Limaye, Director of Medical and Precision Oncology and Oncology Research, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai.

“It is a landmark acknowledgement that the US FDA has recognized the potential benefits of our ‘first in the world’ prostate cancer detection test. The highly coveted ‘Breakthrough Designation’ is granted after very rigorous evaluation. We take great pride in the fact that this test has been wholly developed in India and by Indian scientists and clinicians. This is our ongoing contribution to the Prime Minister’s ‘Atmanirbhar Bharat’ mission after the breakthrough breast cancer detection test and is further intended to augment the global fight against cancer,” said Mr. Rajan Datar, Chairman of the Company. 

Appreciably, getting the test does not involve having to go to any hospital or health centre and waiting for appointments. The blood collection for this test can be done in the convenience and privacy of one’s home or office after which the patient can go about their routine work. From the patient’s point of view, the whole process is very non-intrusive.

The test is already available in Europe and is CE marked. The Company is in discussions with several leading healthcare providers for ready accessibility in India.

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