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.
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