FDA Grants Breakthrough Status to TriNetra-Prostate Blood Test to Detect Early-Stage Prostate Cancer

The FDA has granted a breakthrough device designation to the TriNetra-Prostate blood test for use in the detection of early-stage prostate cancer.

The FDA has granted a breakthrough device designation to the TriNetra-Prostate blood test for use in the detection of early-stage prostate cancer, according to an announcement from Datar Cancer Genetics, Inc.1

The non-invasive, blood-based liquid biopsy, which has previously received CE certification and is already available in Europe (Trublood-Prostate) can be leveraged for the diagnostic triaging of individuals with prostate-related symptoms who may be referred for a prostate biopsy.2 The test was designed to detect prostate-specific circulating tumor cells (CTCs) and CTC clusters and requires 5 mL of blood.

Specifically, the test is indicated for those with elevated prostate-specific antigen or suspicious findings on digital rectal examination who have been advised to undergo an invasive prostate biopsy to check for cancer, those for whom a recent biopsy has been either inconclusive or inconsistent with clinical observations, and for those with known prostate cancer who are suspected of having experienced a metastatic relapse.

“The breakthrough device designation is a recognition of the potential benefits of TriNetra-Prostate in the clinical setting,” Vineet Datta, MD, MCEM, FRCP, FIMSA, CMQ/OE ASQ, executive director of the global oncology research and applications company. “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 not 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.”

This designation is given to devices that showcase a potential for more effective diagnosis of life-threatening diseases, like cancer. The program for breakthrough devices was designed with the goal of providing patients and providers with rapid access to novel medical devices. With breakthrough device status, the product is prioritized for review to expedite its development and assessment.

The test was developed based on data from 2 observational studies (CTRI/2019/01/017219; CTRI/2019/03/017918). In detecting prostate cancer (n = 90) vs benign prostate conditions (n = 289), the sensitivity rate with the test was 100.00% (96.41%-100.00%), the specificity rate was 99.33% (97.60%-99.92%), the positive predictive value was 98.03% (92.58%-99.50%), a negative predictive value of 100.00%, and an accuracy rate of 99.50% (98.20%-99.94%).

In detecting prostate cancer (n = 90) vs asymptomatic individuals (n = 3765), the sensitivity rate was 100.00% (96.41%-100.00%), the specificity rate was 100.00% (97.90%-100.00%), the positive and negative predictive values were both 100.00%, and the accuracy rate was 100.00% (99.90%-100.00%).

The test does not differentiate between ductal and acinar subtypes of prostate adenocarcinoma, nor is it intended for use in determining Gleason score or grade. Although the test can identify an underlying squamous cell carcinoma or a neuroendocrine tumor potentially linked with prostate or another primary organ, appropriate rule-out investigations would be needed to confirm.

Moreover, the test has not been validated for use in the detection of rare subtypes of disease, like basal cell carcinomas. The product is intended for use in conjunction with standard diagnostic workup for prostate cancer, and the findings yielded need to be interpreted and used by a physician in conjunction with other clinical findings, according to Datar Cancer Genetics, Inc.


  1. FDA grants breakthrough designation for Datar Cancer Genetics early-stage prostate cancer detection blood test. News release. Datar Cancer Genetics, Inc.; February 14, 2022. Accessed February 15, 2022. https://prn.to/3I4YciU
  2. For non-invasive diagnostic triaging of suspected prostate cancer patients. Datar Cancer Genetics, Inc. website. Accessed February 15, 2022. https://bit.ly/3gKjRBf