Leica Biosystems’ Aperio ePathology™ System Awarded Health Canada Clearance for Routine Diagnostic Use

| May 10, 2013

In grade school we were taught that nearly all Canadians lived within 50 miles of the United States – Canadian border. We sent them baseball players and they sent us acid rain.  They sent us hockey players, cold fronts and oil.  We sent them football players.  Now Canada is paving the way for the safe and effective use of whole slide imaging in pathology.

For the second time in less than two weeks comes news from a whole slide manufacturer obtaining Class II Medical Device Licensure from Health Canada.  News from Omnyx with their own license came late last month. Another sign the industry is being recognized for the value, quality, effectiveness and safety the technology brings to medicine, specifically, pathology, the foundation of the practice of medicine.

I Survived Toronto 2003Dr. Sylvia Asa, Pathologist-in-Chief and Medical Director at  University Health Network (UHN) Laboratory Medicine Program in Toronto recognized this value proposition a decade ago when I visited the Department of Pathology then to speak about the promise and perils of digital pathology.  My visit then came on the heels of SARS in Toronto and a blackout and a few other things.  

I bought this T-shirt as a souvenir of the visit (click image to enlarge).  

Thank you Canada for Hull, the Esposito brothers, Orr, Gretzky, Toews and validating digital pathology for surgical pathology.


VISTA, CA – May 9, 2013 – Leica Biosystems announced today that its Aperio ePathology solution has obtained a Health Canada Class II Medical Device License.

This important clearance enables pathology professionals to use Aperio ePathology solutions as a diagnostic tool for viewing and managing whole slide images (eSlides) that can be easily shared with others. The ease with which images can be shared helps aid in the interpretation of results.

Now, Canadian healthcare organizations can optimize their pathology operations for consistency and efficiency to support patient care, personalized medicine and research.

“We understand the role that pathology plays in cancer and other diseases, and we believe improving access and transparency of pathology expertise will improve health outcomes,” says Jared Schwartz, MD, PhD, Chief Medical Officer, Leica Biosystems. “We have been working with leading centers in Canada to support the transformation in their practices to ensure easy adoption, which ultimately benefits patient findings and treatment.”

With Aperio ePathology in use and integrated within 60 institutions’ laboratory systems throughout Canada, eSlides are immediately available anywhere for review by a Pathologist. This technology can make a dramatic difference in quality of life for many thousands of people in rural and remote locations in Canada, as well as around the globe, in places where remote populations are without easy access to pathology services.

The University Health Network (UHN) Laboratory Medicine Program in Toronto, one of the largest diagnostic labs in Canada and a recognized leader in the emerging field of digital pathology, has used Aperio ePathology solutions since 2006.  “We are pleased that Health Canada has embraced this technology, as we have done over the past seven years,” said Sylvia Asa, MD PhD, Pathologist-in-Chief and Medical Director at UHN.

The Royal College of Physicians and Surgeons of Canada, in partnership with Aperio ePathology, have implemented the use of eSlides to replace microscopes during the oral component of the Anatomical Pathology examination.  The technology, tested by the Examination Committee and introduced during the 2012 examination, was found to be practical and dependable for use during examination situations.

The adoption of ePathology in Canada has been accelerated as healthcare organizations face even greater regional imbalances of pathology expertise available for patient care.  Aperio ePathology has raised the bar in patient care by enabling very quick access to pathology expertise. The patient has access to pathology expertise and the pathologist has peace of mind.

About Leica Biosystems

Leica Biosystems is a global leader in laboratory workflow solutions for anatomic pathology, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Recognizing there is a shortage of pathology expertise worldwide, as well as increasing subspecialization, Leica Biosystems expanded its capability in pathology imaging with Aperio ePathology Solutions enabling greater access for pathologists through market leading whole slide scanners, Network solutions that enables remote, real-time viewing and easy distribution of images for collaboration and Precision solutions that provide pathologists with easy-to-use quantitative image analysis to improve clinical and research productivity, reproducibility and consistency. Leica Biosystems is represented in over 100 countries. It has manufacturing facilities in 6 countries, sales and service organizations in 19 countries, and an international network of dealers. Further information can be found at www.LeicaBiosystems.com.

Category: Case of the Month, Current Affairs, Device Manufacturers, Digital Pathology News, Education, Government, Laboratory Informatics, Medical Research, TeleHealth

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