The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Datar Cancer Genetics’ 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. In the United States, prostate cancer is the third most common type of cancer, and is associated with more than 32,000 deaths, annually.
Studies have shown that TriNetra-Prostate can detect early-stage cancer with high accuracy 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 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,” says Vineet Datta, MD, executive director of Datar Cancer Genetics.
The test has previously received CE certification and is already available in Europe as Trublood-Prostate.
The Breakthrough Device Designation is granted by the FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical devices granted such designation by prioritized review to expedite development and assessment.
Last year, the company’s early-stage breast cancer detection test also received the FDA Breakthrough Device Designation.
For more information, visit Trublood Prostate.
Featured image: U.S. FDA Grants the Coveted Breakthrough Designation for Early-Stage Prostate Cancer Detection Blood Test Developed in India by Datar Cancer Genetics. Photo: Datar Cancer Genetics