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Non-Invasive, Micro-Biopsy Breast Cancer Test Granted Breakthrough Status

November 20, 2021 • 5:43 am CST
(Vax Before Cancer)

India-based Datar Cancer Genetics Inc. announced on November 19, 2021, that the U.S. Food and Drug Administration (FDA) had granted 'Breakthrough Device Designation for its 'TriNetra™' blood test to detect early-stage Breast Cancer.

The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician's prescription.

The test is already available in Europe and is C.E. marked.

TriNetra uses a proprietary technology developed by the Company to detect Circulating Tumor Cells (CTCs) specific to Breast Cancer.

Studies have shown that TriNetra can detect even Stage 0 (DCIS) and Stage 1 cancers accurately.

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, says the Company.

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.

Datar Cancer Genetics serves cancer patients in the U.K., European Union, U.S., GCC, and India and is pursuing extensive clinical studies to cover multiple cancers which have the potential of cure with early detection. The Company proposes to have various test centers in the U.S. and globally by 2024.