Maharashtra: Nashik co gets US FDA nod for liquid biopsy to detect early breast cancer | Mumbai News – Times of India

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MUMBAI: A Nashik-based cancer laboratory on Friday announced that the US Food and Drug Administration (US FDA) has granted a “breakthrough device designation” for its liquid biopsy test to detect early-stage breast cancer.
US FDA grants such a tag to devices (including tests) that represent breakthrough technology with no alternatives. Last month, it granted the tag to an American company for its liquid biopsy test for early detection of pancreatic cancer.

Usually a biopsy involves removing a piece of tissue or a sample of cells from a patient’s body to detect cancer, but in the past few years there has been increasing research on the non-invasive liquid biopsy method. As the term suggests, liquid biopsy is the process of analyzing tumor material—molecules or whole cells—found in bodily fluids such as blood.
On Friday, the Nashik company, Datar Cancer Genetics, said its TriNetra blood test could detect circulating tumour cells and cluster-specific to breast cancer with accuracy. “Our clinical trials with over 20,000 women have shown the test can detect stage ‘0’ and stage ‘1’ breast cancer with an accuracy better than 99% without any false positive,” said Rajan Datar.
He said the test, which requires 5ml of blood, is already available in Europe and will be launched in the US after it receives marketing authorization from the US FDA. The company’s press release said the test will be available in India shortly. “We are exploring tieups with various chains of laboratories to offer this test,” said Datar.
According to the release, “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 privacy of their home or office.”
Breast cancer is the world’s most widely prevalent cancer. In 2020, there were 2.3 million women diagnosed with breast cancer and 6,85,000 deaths globally. As of the end of 2020, there were 7.8 million women alive who were diagnosed with breast cancer in the past five years. In India, too, it is the most common cancer among women; affecting 25.8 per 100,000 women and with a mortality of 12.7 per 100,000 women.
When contacted, leading breast cancer surgeon and director of the Tata Memorial Centre, Dr R Badwe said there is yet no solid evidence about the efficacy of liquid biopsy. Another doctor said that liquid biopsies are used as a “therapeutic guidance” to check if a treatment modality is working or if the disease has resurfaced.

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