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Leica Biosystems applauds FDA Primary Diagnosis Clearance as a Step Forward in Clinical Acceptance of Digital Pathology


The digital pathology industry just took another step forward, with the FDA clearance of a whole slide imaging (WSI) system (Philips Intelli Site™ Pathology Solution) for review of digital surgical pathology slides.

VISTA, CA–May 11, 2017 – The digital pathology industry just took another step forward,with the FDA clearance of a whole slide imaging (WSI) system (Philips Intelli Site™ Pathology Solution)for review of digital surgical pathology slides.Leica Biosystems congratulates both the FDA and the Digital Pathology Association (DPA)on this positive outcome from their ongoing collaboration.

A founding member of the DPA, Leica Biosystems pioneered the field of Digital Pathology. It was the first company to market commercial digital pathology solutions. In the U.S., Leica Biosystems has clearance from the FDA for Aperio eIHC, an in vitro diagnostic solution to aid pathologists in the interpretation of ER, PR, and HER2 breast IHC.

“Leica Biosystems is dedicated to providing the highest quality solutions for healthcare professionals,“ stated Jerome Clavel, Vice President and General Manager, Leica Biosystems Pathology Imaging. “In addition to its existing FDA clearance for Aperio eIHC, Leica Biosystems is committed to pursuing clinical solutions across its portfolio. Obtaining regulatory clearances has always been one of our central objectives. A multi-site validation study is currently underway in the U.S. This is one of our very highest business priorities.“

“A key goal of Leeds’ strategic partnership with Leica Biosystems is to accelerate adoption by demonstrating the value and return on investment of an integrated digital pathology workflow,” stated Dr. Darren Treanor, Consultant Pathologist, head of the Leeds Digital Pathology Group and Guest Professor at Linköping, Sweden. “However, regulatory clearances are a critical condition for widespread adoption of digital pathology in patient care. We are pleased to see the digital pathology industry continuing to work towards regulatory acceptance.“

IntelliSite is a trademark of Koninklijke Philips N.V. (Royal Philips).

The clinical use claims described for Primary Diagnosis have not been cleared or approved by the U.S. FDA for Leica Biosystems products. Any future capabilities will require FDA clearance before diagnostic use. Aperio eIHC system is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes in breast cancer, as an accessory to Dako ER, PR, and HercepTest™ HER2.

About Leica Biosystems
Leica Biosystems ( is a global leader in workflow solutions and automation, integrating each step in the workflow. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. 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 represented in over 100 countries and is headquartered in Nussloch, Germany.