Bio-Techne Prostate Test Gets 'Breakthrough'

FDA has granted Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based liquid biopsy test to receive such a designation. The breakthrough program is designed to expedite the development, assessment and review of certain devices 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.

Bio-Techne says that by granting the designation, “FDA is acknowledging that there is a need to avoid unnecessary prostate biopsies and that our test helps address this concern. Additionally, the FDA is recognizing the benefit of our approach in analyzing exosomes to provide rapid, patient specific information to guide diagnosis and treatment decisions.”