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FDA grants breakthrough designation to Bio-Techne prostate cancer test

The FDA has granted breakthrough device designation to Bio-Techne's ExoDx Prostate Intelliscore test, which is designed to evaluate a man's risk of developing prostate cancer. "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 Bio-Techne President and CEO Charles Kummeth.

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