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

Leica Biosystems

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


VISTA, California, May 11, 2017 /PRNewswire=KYODO JBN/ --

The digital pathology industry just took another step forward, with the FDA

clearance of a whole slide imaging (WSI) system (Philips IntelliSite(TM)

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

Linkoping, 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


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(TM) HER2.  

About Leica Biosystems

Leica Biosystems (LeicaBiosystems.com) 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.

Media Contact(s): Kristin O'Neill, Manager, Global Brand Marketing,

LBS-GlobalMarketing@leicabiosystems.com , +1-847-821-3537

SOURCE: Leica Biosystems