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Datar Cancer Genetics, with operations in the UK, Germany and India, has announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra-Prostate' blood test to detect early-stage prostate cancer. This is the second test from the company that has received the Breakthrough Device Designation from the US FDA.
Studies have shown that TriNetra-Prostate can detect early-stage cancer with high accuracy (>99 per cent) without any false positives. TriNetra-Prostate requires 5 ml blood and is indicated for males of age 55-69 years with serum PSA of 3 ng/mL or higher. TriNetra-Prostate is based upon the detection of prostate adenocarcinoma specific Circulating Tumor Cells (CTCs) in the blood.
"The test can help reduce the number of biopsies among individuals with benign conditions of the prostate and it can also improve detection rates among those who do have prostate cancer. With our proprietary CTC-enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer," said Dr Vineet Datta, Executive Director, Datar Cancer Genetics.
