Vista, California (ots/PRNewswire) –
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
“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
IntelliSite is a trademark of Koninklijke Philips N.V. (Royal
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 (http://www.leicabiosystems.
com/digital-pathology/digital-pathology-management/imagescope/)) 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,
Media Contact(s): Kristin O’Neill, Manager, Global Brand
Marketing, LBS-GlobalMarketing@leicabiosystems.com , +1-847-821-3537
ots Originaltext: Leica Biosystems Ltd
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Original-Content von: Leica Biosystems Ltd, übermittelt durch news aktuell