The Clinical Benefits and ROI in Digital Pathology Start Here

Change can be painful. For medical laboratories, which are built to avoid any sort of deviation, it can be excruciating. It should not surprise us, then, that pathology’s multi-decade flirtation with digital technology has been, so far, disappointingly non-transformative. Despite the hype and the billions invested, few anatomical pathology labs have made the “digital leap.” Clearly, getting laboratories to go digital is harder than it seems. Economic circumstances haven’t helped the situation, either. Lab managers, already stressed by reduced reimbursements and staff shortages, struggle with the added cost and complexity of digital technologies. In regards to digital transformation, they all seem to be asking the same question: “Where is the return on investment?” Under the circumstances, who can blame them for resisting change?

But what if I told you we found a better way? What if I told you that there is a way to go fully digital, simplify your workflow, all while reducing cost? Yes, it still involves change – lots of it – but if you’re not afraid of the “c” word and read with an open mind, I’ll share a few insights gained from my lab’s journey into the digital realm.

This year marks 10 years since I stepped away from my role as Department Chair in a large health system medical center. Looking back, it was a crazy thing to do, but even though I loved my hospital-based practice, I was becoming increasingly uneasy as I contrasted the pace of tech-driven change outside the hospital, with the resistance to change within. Around that time, my older brother, Mike, analogized my situation to that of a beach-goer, hearing word of a major earthquake hundreds of miles away. He said: “When seismic shifts trigger a tsunami of change, people take one of three paths. Those deeply entrenched in their spot on the beach resist reality and perish in a flood of change. Most beach-goers watch to see what everyone else is doing. Those who pack up their beach chairs and move to high ground soon enough, may survive. Meanwhile, those who recognize the inevitable, and respond appropriately – they are the ones who prosper when the wave changes everything.”

I was growing increasingly aware of the different ways that technologies were unleashing violent change in other fields. “Surely, it was only a matter of time,” I thought, before the wave would hit us in the hospital laboratory. Tectonic shifts in IT were upending where and how people work. “Big data” and cross-modality analytics were everywhere, rippling into every corner of life. Finally, an explosion of computational power was beginning to enable new applications of machine learning that would clearly rock our world in ways we didn’t understand. I realized that these seismic shifts in digital technologies were capable of triggering waves that could fundamentally alter what it means to be a pathologist. Sitting there at my microscope in the hospital, I figured I had a decision to make. My brother’s voice rang out in my head: “Three paths: resist change, and you perish… wait for others, and maybe you survive… lead the change and prosper.”

By virtue of the fact that I’m writing this story, it’s probably not surprising that I chose to embrace the path of change. Thankfully, I haven’t been alone on this journey. I convinced my pathologist partner, Jared Szymanski, to join me along the way. Our first foray into digital pathology began like many others’ at the time – we went right out and bought a really expensive slide scanner. Since we couldn’t convince our hospital administrators to shell out the money for the scanner, Jared and I sold our spouses on the idea that this would one day turn out to be a great investment. However, we quickly learned the same sad lesson so many others have since learned: glass was both faster and cheaper than digital. More disturbingly, we actually liked working with microscopes more than monitors. It was a tough, but important admission, and thankfully, both of our wives forgave us for our foolish investment.

The turning point

As our high-throughput digital-dinosaur sat gathering dust, we asked ourselves why the digital workflow was so inefficient for the lab and what made signing out digitally so unappealing for us as pathologists. Though painful to face those questions, it was a pivotal moment. We realized that a digital pathology workflow only makes sense economically if the entire process, whether patient to bedside, tissue to block, image-acquisition to diagnosis, report-building to ancillary-test-ordering – it all had to be digital pathology. Realizing that digital pathology transformation was more than just scanning and viewing slides on a monitor opened our eyes to the fact that histopathology as we knew it has been an innovation desert for decades. We realized that if we could integrate next-generation tissue handling technologies with digital imaging systems, we could vastly improve quality and efficiency and achieve the digital dream.

We pulled together a small team of engineers, software developers, and histotechnologists to reimagine how we might improve the entire workflow. Together, we designed a process that would eliminate paper requisitions, hand-labeled specimen jars, and the various inefficient ways of fishing tissue-flecks from formalin jars. Realizing that we lacked sufficient resources to redesign workflows for all specimen types, we decided to focus our efforts on one specimen type at a time. We started with prostate needle-core biopsies – we chose prostate because these biopsies are generally a pain for labs, and have significant variability in quality.

BxBoard

We started at the patient’s bedside aiming to improve the quality of the tissue arriving in the lab, while improving ease of use for the clinic. The BxBoard, a replacement for formalin bottles, is a six-lane tissue transportation device that fixes tissue on a special formalin-soaked sponge. A surgeon or assistant carefully transfers tissue cores directly from the biopsy needle to the BxBoard. The Board’s design establishes and maintains tissue orientation (without ink) and enables tissue to fix on an even geometric plane. Clinics love the efficiencies during the biopsy procedure, and labs have universally reported significant increases in tissue on the slide. Preservation of molecular biomarkers also appears to be enhanced as quantity not sufficient rates dramatically fell when compared to formalin jars.

BxChip

Once in the lab, the tissues are transferred from the BxBoard to corresponding lanes in the BxChip. The BxChip is a clinical tissue array holding up to six cores in a tissue-like matrix that processes and cuts just like tissue. The BxChip was invented by members of our Romanian research team led by Sorin Musat. The chip maintains tissue orientation, holds the tissue on an even plane, and significantly reduces slide and block count for labs. Labs who have used this technology have reported a 76 percent decrease in tech time per prostate biopsy, a 136 percent reduction in biohazard waste, an 83 percent reduction in cassettes and glass slides, and an 83 percent reduction in stain costs.

The power of standardizing pre-analytic workflow

But what does this all have to do with digital pathology? By standardizing the way specimens are transported, documented, processed, and embedded, we have been able to translate gains in physical lab efficiency into massive gains in digital workflow efficiency. Combining AI tissue detection with Lumea’s artificial tissue fiducial has created massive efficiency gains for pathologists. The algorithms recognize and track each tissue in the different BxChip lanes, which enables the computer to accurately measure and keep track of each specimen. As the pathologist annotates digital slides, the system automatically calculates tumor size and percentage involvement, auto-filling the pathology report in real-time as they review the case. Lumea also partners with many different AI companies, enabling users to pick and choose from a list of vendors if they’d like to use AI for quality control checks or to automate other tasks.

We have seen a 50 percent reduction in diagnostic time per case for the pathologist. Among the many labs adopting the system, we have seen significant increases in biopsy core length, and, most notably, an increase in prostate cancer detection rates. It is rare to find anything that increases quality while improving efficiency. And yet, harmonizing standardized tissue handling with our digital imaging tools has achieved this remarkable improvement in value.

I’m very proud of what our multidisciplinary team has been able to create. Over the last 10 years, these tissue handling technologies have touched hundreds of thousands of patients all around the world. In many labs where digital transformation is not yet ripe for adoption, the tissue handling technologies stand by themselves. However, when the inevitable waves of change push every lab to make the digital leap, those labs that have already adopted these tissue handling tools will be able to seamlessly transition into a digital workflow with an actual return on investment.

It is my hope that other pathologists and labs who adopt these next generation tissue handling systems will not need to question the wisdom of their decision to go digital. Rather, for them, the seismic change brought about by digital technology should be totally evident.

For more information visit: LumeaDigital.com