Tuesday, Aug 11, 2020

Digital Pathology is No Longer the Future of Medicine—It’s a Necessity of Today


The COVID-19 crisis has created tremendous healthcare delivery challenges due to the difficulty of both doctors and patients to meet in person. These challenges have been increasingly addressed via digital and telehealth technologies to enable doctors and patients to connect safely and maintain continuity of care. Although digital and telehealth technologies have been available for years, historically these technologies experienced barriers of poor reimbursement and regulatory restrictions that led to low adoption rates. These barriers are increasingly being addressed due to the COVID crisis with additional support from payers and regulatory bodies.  

Although consumer-facing telehealth has received the most attention, there are other areas of medicine undergoing similar transformations. In particular, pathology has faced a unique challenge during the COVID crisis. Because pathologists practice in-person using optical microscopes to view tissue slides that are often handled by multiple individuals and are routinely shipped to other institutions for second opinions, pathologists have faced a personal risk during the COVID crisis. In fact, early in the pandemic, a prominent pathologist at the University of Washington tragically passed away from COVID-19.

Fortunately, the technology exists to support pathologists to work remotely and safely. High-volume digital slide scanners and digital pathology slide viewers enable both the digital transmission of slides and remote work. Despite the availability of technology, other challenges remained including the low adoption of digital pathology infrastructure prior to the crisis and regulatory barriers that restricted pathologists to performing primary diagnoses only in a lab certified by the Clinical Laboratory Improvement Amendments (CLIA). The College of American Pathologists advocated CMS for the flexibility to work remotely and in March, CMS waived those requirements as a public health emergency response.

Even before COVID-19, there was a strong case for adopting digital pathology in hospitals and labs. Digital pathology increases the availability and efficiency of pathologists and improves response times to patients, streamlines second opinion processes, and makes querying archives far easier.

The need for a digital pathology solution will only become more acute as the increase in demand for tests is amplified by a decreased pathologist workforce. According to the Journal of the American Medical Association, the number of active pathologists decreased by about 18% in the last decade. At the same time, the WHO estimates that the number of new cancer cases will rise by ~60% over the next two decades. This increase in cases with a decrease in the workforce is leading to pathologists who are struggling to keep up with their workloads, impacting patient outcomes, value-based payments, and creating overall conditions of workplace burnout. 

Paige technology offers solutions to both problems. Our digital pathology enterprise imaging solution includes a digital slide viewer, FullFocusTM, that was recently FDA-cleared for primary diagnosis. It is designed for high performance and offers increased interoperability across scanners and monitors (for now, the initial clearance is in conjunction with Philips Ultra-Fast scanners). Our digital pathology technology offers pathologists the ability to safely work and collaborate while enabling hospitals and labs to maintain business continuity during this crisis. Furthermore, our upcoming digital diagnostics portfolio will provide actionable information to pathologists during diagnosis leading to enhanced diagnostic confidence, productivity and faster results for patients across multiple cancers and biomarkers. 

COVID-19 has challenged pathologists, hospitals, and labs to provide continuity of quality care while maintaining safety for pathologists. Fortunately, the technology to meet this challenge exists today and is rapidly being adopted by hospitals, labs and pathologists around the globe. Paige is excited to support this critical practice in medicine today and bring many more breakthroughs to the field in the future.

About Leo Grady:

Leo Grady joined Paige as CEO in early 2019, bringing with him leadership experience and expertise in cutting-edge clinical software. He has more than 15 years of experience in prototyping, developing, and bringing to market some of the industry’s most advanced machine learning, computer vision, and medical imaging technologies and products. Since joining Paige as CEO, Leo led the company to receive FDA Clearance and Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). Prior to joining Paige, he was the Senior Vice President of Engineering and Product at HeartFlow, a leading computational diagnostics company. Previously, Leo served in a variety of scientific and leadership roles at Siemens. The author of two books, over 100 peer-reviewed journal and conference papers, and the owner of 300 issued or pending patents worldwide, he was inducted as a Fellow in the American Institute for Medical and Biological Engineering in 2014. In 2012, he was the recipient of the Edison Patent Award in medical imaging. Leo received a B.Sc. degree in Electrical Engineering at the University of Vermont and a Ph.D. in Cognitive and Neural Systems from Boston University.

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