Full Press Release Details
MINNEAPOLIS , June 17, 2019 /PRNewswire/ -- Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical importance of Bio-Techne's EPI test, it also marks a milestone in the advancement of the company's patented technology platform.
The Breakthrough Devices Program is intended to accelerate 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. It is available for devices and device-led combination products that are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. The Breakthrough Device program is designed to expedite the development, assessment and review of these products through interactive and timely communication, pre/post-market balance of data collection, efficient and flexible study design, review team support, senior management engagement and priority review so that patients can have more timely access to these medical devices.
About Bio-Techne Corporation (NASDAQ: TECH )
Contact: David Clair Investor Relations [email protected] Phone: 646-277-1266
SOURCE Bio-Techne Corporation