Leica Biosystems Receives FDA 510(k) Clearance to Market a Digital Pathology System for Primary Diagnosis
VISTA, CA –May 29, 2019 – Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.
A multi-center study supporting this clearance was conducted with pathologists at 5 clinical study sites in the U.S.: University of California Davis, Pacific Rim Pathology, Dignity Health, TriCore Reference Laboratories, and Intermountain Healthcare. One of the largest clinical concordance studies ever completed on digital whole slide images, the participating pathologists read approximately 16,000 cases. The study compared reads of pathology slides under a microscope with on-screen digital reads.
“We are very grateful for the hard work of our clinical partners, including the adjudicators and advisors, as well as the pathologists and staff of our study sites,” said Colin White, Global Vice President of Leica Biosystems Advanced Staining & Imaging business. “This is a momentous step forward in the integration of digital pathology into routine patient care.”
The Aperio AT2 DX System is a high-throughput automated scanning and viewing platform. The platform will be launched commercially with clinical image management software for an integrated digital pathology workflow solution.
About Leica Biosystems
Leica Biosystems (LeicaBiosystems.com) is a cancer diagnostics company and a global leader in workflow solutions, offering the most comprehensive portfolio from biopsy to diagnosis. With unique expertise, we are dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is headquartered in Germany and operates in over 100 countries.