US FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics
It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years
London, November 19, 2021 – Datar Cancer Genetics, a leading cancer research company focussed on early detection of cancers today announced that 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. The objective of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices granted such designation by expedited development, assessment, and review.
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.
“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 ‘TrucheckTM’ and is CE marked.
The Company has also validated a blood test to detect multiple cancers including several extremely lethal malignancies such as Lung, Pancreas and Ovaries and will be available next year.
About Datar Cancer Genetics
Datar Cancer Genetics is a leading cancer research corporation specialising in non-invasive techniques for better diagnosis, treatment decisions, and management of cancer. The Company’s state-of-the-art cancer research centre is ISO, CAP and CLIA accredited with facilities in Guilford, United Kingdom and India. The Company serves cancer patients in the UK, European Union, United States, GCC and India. The Company is pursuing large clinical studies with more planned in the United States and Europe to cover multiple cancers which have the potential of cure with early detection. The Company proposes to have multiple test centres globally by 2024.
Dr Vineet Datta