Datar Cancer Genetics has received the US Food and Drug Administration (FDA) breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer.

TriNetra-Prostate is designed to identify people who are most likely to harbour prostate cancer and supports the clinical decision making on a biopsy for confirmatory diagnosis.

The test requires 5ml blood and works based on the detection of prostate adenocarcinoma specific Circulating Tumor Cells (CTCs) in the blood.

It is indicated for males aged 55-69 years with serum PSA of 3ng/mL or higher.

Datar Cancer Genetics executive director Vineet Datta said: “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.”

TriNetra-Prostate is the company’s second test to receive the FDA breakthrough device designation, following its early-stage breast cancer detection test.

In the studies, the test has confirmed its capability to detect early-stage cancer with high accuracy of 99%, without any false positives.

TriNetra-Prostate has previously received CE certification and is already being commercialised in Europe under the brand name Trublood-Prostate.

Datar Cancer Genetics is an oncology research and applications company focused on non-invasive technologies for improved detection, treatment, and management of cancer.

The company’s advanced facility is NABL, ISO, CAP, CLIA accredited and serves cancer patients and suspected cases worldwide.

It is pursuing large clinical studies in the US to cover early detection of multiple cancers with plans to have multiple test centres in the US and worldwide.