Digital Pathology: The Future is Here

Our rapidly advancing world has been unfolding in high fidelity for years now. The digital transformation of life is happening so fast that it has become harder for even the most technically savvy individuals to keep up with it all. New concepts like Quantum Internet, Qubits, AI, autonomous vehicles, Web3, the Metaverse, and more are making breakthroughs daily. However, despite these advances, efforts to integrate digital pathology workflow into clinical diagnosis continue to experience resistance. 

Although digital pathology was developed decades ago, it wasn’t until April of 2017 that the U.S. Food and Drug Administration (FDA) permitted the marketing of the first whole slide imaging (WSI) system, the Philips IntelliSite Pathology Solution (PIPS). PIPS was revolutionary because it was an automated digital slide creation, viewing, and management system that enabled pathologists to review and interpret digital images of surgical pathology slides. These slides were prepared from formalin-fixed paraffin-embedded (FFPE) tissue. 

With PIPS, pathologists gained a digital option as an alternative to looking directly under a conventional light microscope at a tissue sample mounted on a glass slide. Although this represented a big step forward in the pathology community, continued innovation of digital pathology hasn’t kept pace with overall technological advances in other healthcare sectors.

“Unique circumstances are stunting the growth of digital pathology,” said Tony Oganesian, LigoLab’s Chief Technology Officer. “This includes a combination of overregulation, tight reimbursement, and a lack of investment within the healthcare system. However, pathology's dwindling workforce and increasing caseloads have made complete digitization inevitable.”

How the Pandemic Opened the Door for Digital Pathology Solutions

Over the years, pathologists in the U.S. have pondered what it might take for digital pathology to become the industry standard. Many small steps were made, but real momentum was always on the distant horizon. That was until the COVID-19 pandemic arrived in 2020 and changed the landscape.

“At first, when the pandemic hit and stay-at-home orders were enacted, it seemed that pathology would suffer from a slowdown,” said Oganesian. “As hospitals closed their doors and non-essential medical treatments were halted, pathologists began to worry. But then the FDA loosened its grip and started issuing waivers and emergency use authorizations for advances that until then had been stuck in the review pipeline. From that, digital pathology experienced an innovation boom.” 

An example of this notion is when the FDA loosened restrictions on work-from-home arrangements for pathologists. In April 2020, the FDA granted a waiver allowing the use of readily available consumer monitors at home, specifically with the Philips digital pathology solution. Pathologists who had been unable to work on-site, due to the pandemic, were now allowed to review anatomic pathological cases from home. This played a huge role in helping pathologists prevent delays in critical patient care.

Less Digital Pathology Regulation Equals More Innovation

This was also a giant leap forward for digital pathology solutions in the U.S. In its essence, digital pathology was developed for this purpose - to allow pathologists to remotely collaborate on cases by sharing digital images across laboratories. 

Before the pandemic, the U.S. was decades behind other developed countries in adopting digital pathology solutions and realizing the benefits of digital pathology. Strict regulations by the FDA and the Clinical Laboratory Improvement Amendments (CLIA) from the Centers for Medicare & Medicaid Services (CMS) effectively stunted digital pathology advances. Thankfully, the FDA relaxed some of its requirements to approve digital pathology-related technology and meet the immediate needs brought on by the pandemic. 

Similarly, CMS waived restrictive CLIA rules, allowing pathologists to use digital platforms from home and accelerating the broader adoption of digital pathology solutions for remotely rendering diagnoses. This paradigm shift has accelerated how digital pathology systems can be utilized and gain approval for diagnostic usage. 

“Now that our healthcare system has experienced the benefits of digital pathology and rapid innovation, there is hope that some of the legacy roadblocks that slowed progress will continue to be a thing of the past,” said LigoLab CEO Suren Avunjian. “Technologies that enable pathologists to work more efficiently and effectively will ultimately lead to better patient care and reduce healthcare costs.”

The Role of the Laboratory Information System in Digital Pathology Solutions

LigoLab’s pathology lab software (laboratory information system software) provides an end-to-end laboratory workflow management solution for molecular, clinical, and anatomic pathology labs. The LigoLab LIS & RCM Laboratory Informatics Platform supports all whole slide imaging systems, and that’s been the case for well over a decade.

“An ideal digital pathology ecosystem is one where all of a lab’s systems are interoperable, connecting as an integrated digital workflow,” said Oganesian. “For example, the LigoLab platform, specifically the platform’s interface engine, can interface with every laboratory software system a lab works with, including all digital pathology solutions.”

LigoLab provides a foundation for the digital pathology ecosystem, which consists of three major components: a laboratory information system (LIS system), a digital pathology system, and digital pathology system tools. Digging even deeper, the primary components of a digital pathology system include a whole slide scanner, a software whole slide image viewer, and a display monitor. 

So how do all of these pieces work together? 

The scanner produces a digital copy of the traditional glass slide, to be stored on a local or cloud-based server, and then viewed anywhere via a computer and internet connection. Current scanners provide high-fidelity digital images, with a capacity of up to a thousand slides, and they promote fast, reliable operation with very little human intervention. Additionally, digital archives are more manageable than analog. Prior cases are easily available for comparative review, minus the shipping and storing of glass slides.

LigoLab’s Powerful Interface Engine  

A whole slide imaging (WSI) system like the Philips Imaging Management System (IMS) viewer works with the LigoLab platform, seamlessly connected via LigoLab’s powerful interface engine. To learn more about this integration and the benefits of digital pathology, we’ve included a real-life example/tutorial of how a longtime customer is leveraging LigoLab’s pathology lab software to create its digital pathology workflow. Video highlights include:

• Contextual launch of Philips IMS within LigoLab
• LigoLab LIS and Philips IMS user interfaces working in tandem
• Shared ascension numbers
• Using LigoLab LIS for case assignments
• Voice-to-text transcription and notes support
• Importing slide snapshots into LigoLab LIS
• Custom reports

As referenced earlier, the LigoLab platform brings all of the components of digital pathology together and into the broader health IT ecosystem through its interface engine, which enables seamless interoperability. The engine supports data transfer through all formats, including FHIR, HL7, XML, X12, CSV, PDF, Flat File, ASTM, and Restful API). Going even further, this engine is backed up by a talented interface department that intimately understands the pathology lab software and offers several levels of integration services for its customers.

“If an electronic device can be interfaced with, our team can connect to it,” said Oganesian. “Our interface engine supports any level of interface customization. Our core mission is to be a complete, all-in-one pathology lab software solution for laboratories and their partners.”

Today’s digital pathology transformation brings multiple advantages to pathologists and patients. Early adopters that utilize the LigoLab platform to support their digital pathology operations report many benefits, including efficiency gains, better case allocation across digital pathology networks, and improved scalability. 

LigoLab’s Award-Winning Pathology Lab Software 

LigoLab is an award-winning provider of innovative end-to-end pathology lab software for medical laboratories, servicing nearly 300 facilities nationwide. As a comprehensive enterprise-grade LIS software solution, the LigoLab LIS & RCM Laboratory Informatics Platform™ includes modules for anatomic pathology, clinical pathology, molecular diagnostics, laboratory revenue cycle management (lab RCM), and direct-to-consumer lab testing, all on one powerful and integrated laboratory information system that supports every role, every department, and every case. 

LigoLab empowers laboratories to serve patients better, differentiate themselves in the marketplace, scale their operations, and become more compliant and profitable.