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.“