FDA Grants Breakthrough Device Designation to Blood Test for Detecting Early-Stage Prostate Cancer


Datar Cancer Genetics announced that its TriNetra-Prostate blood test, which was developed to detect early-stage prostate cancer, received breakthrough device designation from the FDA.

The FDA granted has breakthrough device designation to a blood test capable of detecting early-stage prostate cancer, according to a press release from developer Datar Cancer Genetics.1

The TriNetra-Prostate blood test is the second Datar Cancer Genetics’ test to receive this designation, following in the footsteps of an early-stage breast cancer detection test that was approved in November 2021.2

“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 [circulating tumor cells]–enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer,” Vineet Datta, MD, FRCP, executive director at Datar Cancer Genetics, said in a press release.

Data have indicated that the TriNetra-Prostate blood test detects early-stage prostate cancer with more than 99% accuracy. The test requires 5 mL of blood in which prostate adenocarcinoma–specific circulating tumor cells can be detected.

The blood test identifies men who are more likely to harbor tumors in the prostate and ultimately aids in the clinical decision-making process by determining whether a biopsy is necessary for confirmatory diagnosis. The test is indicated in male patients between the ages of 55 and 69 years who have a serum prostate-specific antigen level of 3 ng/mL or higher.

TriNetra-Prostate previously received CE certification in Europe under the name “Trublood-Prostate” and is currently available.

Breakthrough device designation is granted to devices that “demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer” and intends to “provide patients and healthcare providers with timely access to medical devices.”


  1. FDA grants breakthrough designation for Datar Cancer Genetics early-stage prostate cancer detection blood test. News release. Datar Cancer Genetics. February 14, 2022. Accessed February 16, 2022. https://tinyurl.com/2p8hezp3
  2. FDA grants breakthrough designation for early-stage breast cancer detection blood test developed by Datar Cancer Genetics. News release. November 19, 2021. Accessed February 16, 2022. https://prn.to/3uXm30A
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