A blood test developed in India by Datar Cancer Genetics that can detect breast cancer in the early stage was granted breakthrough designation by the US Food and Drug Administration.
It was claimed by the company that this new blood test would provide about 99 per cent accuracy in detecting the early stages of breast cancer.
Reviewing of drugs comes under the process of breakthrough designation, which is designed to expedite the development and is intended for treating serious conditions.
The initial clinical pieces of evidence indicated that over available therapy and treatments, the drug might demonstrate considerable improvement.
New technology was developed by the company, which detects tumor cells circulating and cluster-specific to breast cancer with high accuracy.
The clinical trials conducted were promising and showed that Stage 0 (DCIS) and Stage-1 breast cancer can be detected by the test and without any false positive, an accuracy of over 99 per cent, the Datar Cancer Genetics said in a statement.
Datar Cancer Genetics further added in the statement that over 20,000 women were diagnosed under the clinical trials, which comprised healthy as well as cancer patients.
The test is conducted with a mere five ml of blood, plus there is no risk of exposure to any kind of radiation or discomfort associated with Mammography, as stated categorically by company officials.
Datar Cancer Genetics Chairman Rajan Datar said in a statement that women over 40 years of age could obtain a cancer-specific blood test from the privacy and convenience of their workplace or homes in consultation with their physician.
Chairman Rajan Datar further added that the US FDA’s approval of this test underscores the potential of this blood test which could bring a profound change in the cure and early detection of this dreadful disease worldwide.
In the European market, this test is already available in the market and would arrive in the Indian market shortly under the brand name ‘EasyCheck.’
As the company has not disclosed any price range for this test, the pricing of this test is under discussion with a number of leading healthcare providers to increase its accessibility for the people.
Chairman Rajan Datar said that it is a matter of pride that the scientists and clinicians of India have put the country at the core of global cancer research, setting a great example of ‘”Atmanirbhar Bharat” envisioned by Prime Minister Narendra Modi.