US FDA Grants the Coveted Breakthrough Designation for Early-Stage Prostate Cancer Detection

It is the first blood test able to detect early-stage Prostate Cancer with high accuracy in men aged 55 years and above MUMBAI, India, Feb. 14, 2022 /PRNewswire/ -- 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 the Company that has received the Breakthrough Device Designation from the US FDA. Late last year, the Company's 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. 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.

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