Early-Stage Prostate Cancer Detection Blood Test Granted FDA Breakthrough Designation

Datar Cancer Genetics Inc. (Surrey, UK) has been granted 'Breakthrough Device Designation' for its 'TriNetra-Prostate' blood test to detect early-stage prostate cancer. The test can identify individuals who are more likely to harbor cancer in the prostate and aids clinical decision making such as the need to undergo a biopsy for confirmatory diagnosis. The test has previously received CE certification and is already available in Europe as 'Trublood-Prostate'.

Studies have shown that TriNetra-Prostate can detect early-stage cancer with high accuracy (>99%) 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 CTCs in the blood.

"The breakthrough device designation is a recognition of the potential benefits of TriNetra-Prostate in the clinical setting. 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 of the Company.

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Datar Cancer Genetics Inc.