Datar Cancer Genetics has received the US Food and Drug Administration (FDA) breakthrough device designation for its blood-based test to detect early-stage breast cancer.
The test, which requires only 5ml blood, is indicated for prescription use in asymptomatic women aged 40 years above for early detection of breast cancer.
The Nashik, India-based cancer research company designed the test leveraging its unique technology to detect Circulating Tumour Cells (CTCs), which are specific to breast cancer.
In the studies, the test has shown its potential in detecting even Stage 0 (DCIS) and Stage 1 cancers with superior accuracy.
The test has already received CE mark approval, and the company is commercialising the test in Europe under the brand name ‘Trucheck’.
According to Datar, it is the first blood test capable of detecting early-stage breast cancer with high accuracy, in women under the indicated age-group.
Datar Cancer Genetics executive director Vineet Datta said: “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.
“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 tumour rather than fragments of dead cells.”
Datar Cancer Genetics is a cancer research firm focused on non-invasive techniques for diagnosis, treatment decisions, and management of cancer.
The company’s advanced cancer research centre in Guilford, UK and India has been accredited with ISO, CAP and CLIA certifications, said the company.
Furthermore, Datar is planning for large clinical studies in the US and Europe to cover multiple cancers which have the potential of cure with early detection.
