Mumbai: Nashik-based Cancer Laboratory on Friday announced that Food and Drug Administration (US FDA) has given “the appointment of a breakthrough device” to test the liquid biopsy to detect early stage breast cancer.
US FDA provides such tags to the device (including tests) representing breakthrough technology without alternatives.
Last month, he gave a tag to American companies for a liquid biopsy test for early detection of pancreatic cancer.
Usually biopsy involves removing a piece of network or cell sample from the patient’s body to detect cancer, but in recent years there has been an increasing research on non-invasive liquid biopsy methods.
As the term shows, liquid biopsy is the process of analyzing molecules-molecules or all cells – found in body fluids such as blood.
Friday, Nashik Company, Flat Cancer Genetics, said Trinetra blood tests can detect circulating tumor cells and clusters for breast cancer with accuracy.
“Our clinical trial with more than 20,000 women has shown tests can detect the ‘0’ stage and stage ‘1’ breast cancer with better accuracy than 99% without fake positive,” said Rajan flatly.
He said the test, which needed 5ml blood, was available in Europe and will be launched in the US after receiving the marketing authorization from the US FDA.
The company’s press release said the test would be available soon in India.
“We explored Tieup with various laboratory chains to offer this test,” said flat.
According to the release, “This for the first time a woman over 40 years can get a special breast cancer blood test in consultation with their doctor from the privacy of their homes or offices.” Breast cancer is the most common cancer in the world.
By 2020, there were 2.3 million women diagnosed with breast cancer and 6.85,000 deaths globally.
At the end of 2020, there were 7.8 million living women diagnosed with breast cancer in the past five years.
In India too, it is the most common cancer among women; Affect 25.8 per 100,000 women and with 12.7 per 100,000 women mortality.
When contacted, the leading breast cancer surgeon and Tata Memorial Center Director, Dr.
R Badwe said there was no strong evidence of the efficacy of liquid biopsy.
Other doctors say that liquid biopsy is used as a “therapeutic guide” to check whether treatment modalities function or if the disease has reappeared.