PR93188

LONDON, November 20, 2021 /PRNewswire=KYODO JBN/ --

   - It is the first blood test able to detect early-stage Breast Cancer with

high accuracy in women above the age of 40 years

   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 'Trucheck[TM]' and is CE marked.

   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.  

   Media contact:

   Dr Vineet Datta

   drvineetdatta@datarpgx.com  

   Website: datarpgx.de [https://www.datarpgx.de/]

   Photo: https://mma.prnewswire.com/media/1572837/Trublood_Prostate_Cancer.jpg

   Logo: https://mma.prnewswire.com/media/1572835/Datar_Cancer_Genetics_Logo.jpg

   Source: Datar Cancer Genetics