Bio-Techne’s Prostate Cancer Test Grabs Breakthrough Device Designation

The FDA has handed Bio-Techne breakthrough device designation for its ExoDx Prostate Intelliscore test, a diagnostic used to assess a man’s risk of prostate cancer.

The non-invasive test uses a urine sample to perform a liquid biopsy for prostate cancer and is uniquely able to identify high-grade prostate cancer at the time of biopsy and surgery.

“This assay [has the] ability to give urologists a more precise, genetically informed understanding of a man’s risk for aggressive disease via a simple urine sample, without the need for an invasive prostate tissue biopsy,” said Charles Kummeth, president and CEO of Bio-Techne.