Bio-Techne Prostate Test Gets FDA Breakthrough Designation

Bio-Techne today announced that the U.S. FDA has granted breakthrough device designation to its ExoDx Prostate IntelliScore (EPI) test.

• Program is intended to speed the regulatory review process for certain medical devices and device-led combination products that provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
• “By granting our EPI test Breakthrough Device Designation, the FDA is acknowledging that there is a need to avoid unnecessary prostate biopsies and that our test helps address this concern,” said CEO Charles R. Kummeth

Link to Statement: FDA Grants Breakthrough Device Designation To Bio-Techne’s ExoDx™ Prostate IntelliScore™ ...