FDA Grants Breakthrough Designation to blood test for detecting Early-Stage Breast Cancer
LONDON - The US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its blood test to detect early-stage Breast Cancer. The Breakthrough Designation is granted by the US FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer.
It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years.
The test uses a proprietary technology developed by the Company to detect Circulating Tumor Cells (CTCs) specific to Breast Cancer. Studies have shown that the test can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy. The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician's prescription.
Worldwide more than 2.3 million women are detected with Breast Cancer each year and early detection is considered critical for cure.If detected early, Breast Cancer can be cured in almost 99% of the cases.
The test has been validated on more than 20,000 women comprising healthy and cancer patients. The test requires only 5 ml blood and does not involve exposure to any radiation or discomfort associated with mammography.
"We are pleased that the FDA has recognized the potential of our test for the detection of early-stage Breast Cancer. We believe that the test will offer definitive advantages for Breast Cancer screening once it receives marketing authorization from the FDA," said Dr Vineet Datta, Executive Director of the Company. The Company believes that detection of CTCs is the most dependable and accurate method for early detection of cancer as it enables capture and characterization of functional components of a tumor rather than fragments of dead cells. In that sense, CTCs represent a true non-invasive micro-biopsy.
The test is already available in Europe as 'Trucheck™' and is CE marked.