July 2025—What’s new from Roche, Hologic, and Siemens Healthineers, and how they aim to lighten for labs the burden of the workforce shortage. CAP TODAY publisher Bob McGonnagle spoke about these and other things with three company representatives in an online roundtable, and Stan Schofield, Compass Group managing principal, told them what three questions companies must answer to get a laboratory’s business. Their June 2 conversation follows.
Jim Richter, tell us about Roche’s product introductions for the summer and fall trade shows.
Jim Richter, MD, pathology liaison in medical and scientific affairs, Roche: You’ll continue to hear into this year about our mass spectrometry instrumentation and solution, which was first announced last fall and will be featured at ADLM, and about our growing menu of companion diagnostics, most recently c-Met IHC, among others. People will be talking about the FDA clearance for our digital pathology solutions and our growing number of partnerships with third-party digital pathology algorithms and tools.
Alex Cameron, you’ve had important product introductions recently. How are those coming along and what might we look for from Siemens in the next three or four months?
Alex Cameron, MBA, VP and head of Atellica Solutions, Siemens Healthineers: Sustainability is a core focus across the company, and we are proud to be the first IVD vendor to have clinical lab instruments that have earned the My Green Lab ACT Ecolabel. A lot of work went into how we design our systems to use less water and produce less waste.
At ADLM this year the certified Atellica Solution will be introduced. This allows us to repurpose Atellica instruments from the field. They’re sent to our factory in Swords, Ireland, where they’re stripped down, rigorously restored, and then placed back in the field. With this we’re able to reduce scrap by up to 100,000 kilograms a year. The instruments are certified and have the same warranty, useful life, and operability as a new system. After earning this label and rethinking our manufacturing process across the board, sustainability is something you’ll see from us.
Sarah Harrington, what can our readers and your customers expect to see from Hologic in the coming months?
Sarah Harrington, PhD, director of scientific affairs, Hologic: Digital cytology is a big focus of ours. Last year Hologic received FDA clearance for the Genius Digital Diagnostics System, or Genius Dx. It is the first and only digital cytology system with assistive AI for cervical cytology review cleared by FDA. This is an important innovation because Pap testing is a high-volume test in the United States but we are seeing laboratory workforce shortages that make it difficult to maintain turnaround time. Adding Genius Dx improves efficiency in several areas of the lab, allowing efficient and accurate Pap test reviews. Genius Dx was launched in Europe in 2020, and we started rolling out in the United States last year.
There’s a lot of excitement about this, that it’s going above and beyond the boundaries of what we might think of as a narrowly defined side of the pathology and cytotechnology markets, correct?
Dr. Harrington (Hologic): Exactly. Cytology has been challenging to image using traditional digital pathology scanners in the past due to the three-dimensional nature of cells. The images were either in focus with long scan times and large file sizes or were out of focus. The Genius Dx was built specifically for cytology, using volumetric scanning technology. This allows the full depth of focus to be captured in a single pass of the slide and the most in focus pixels are merged to create a two-dimensional image where the entire cell spot is in focus. As a result, the image is captured quickly and the file size manageable—two things that are critical to widespread clinical use.
Beyond our Genius Dx for gynecological cytology, we are looking to add additional functionality as we go forward.
Stan Schofield, can you give readers of CAP TODAY advice on what people should think about as they evaluate new offerings?
Stan Schofield, managing principal, Compass Group (formerly of NorDx/MaineHealth): As you know, I do not represent a single brand or company. Going into ADLM, 50 percent of hospitals are still losing money, and the personnel shortage is still critical.
There are three questions a company must answer to get my business: How does your solution improve my service, enhance my quality, and reduce my expenses? If you can answer two, we’ll have a nice visit but you’ll be on your way. Three out of three, we can sit down and consider what you have.
The background on this is around what the lab needs are today. Staffing is critical, and automation is the solution, but most solutions are costly. There’s not much of a return on investment. In microbiology, it takes 10,000 cultures a month to break even. In phlebotomy, it’s not a refined or defined technology today, but it’s our most critical need. We need people-to-people contact. It’s an entry-level position, not a career path most people aspire to, and a huge problem. In anatomic pathology in the past two or three years, histotechnologists have hit the traveling market, so more automation on embedding and tissue processing, microtomes—they’re all starting to come together. Expensive solutions with mediocre results.
The second area is more digitization. Pathologists want digital pathology mostly for convenience. It costs a lot of money and adds cost to existing baselines. Convenience is nice, but critical need is still not well proven or well demonstrated. And you’d better pick the right brand because several digital pathology companies have had their share of problems.
Digitization in the lab is around less paper and more diagnostic support, which is where the next element of this is—AI. AI is everyone’s buzzword, but practical, real-life operational improvements in the lab haven’t materialized. Labs have to compete for these resources. And it’s a tough argument to sell for funding given the poor track record. Early adopter labs are paving the way, but it has not been smooth.
The final aspect is faster, cheaper, better patient experiences. Where does the one-hour turnaround time from a fingerstick for chemistry and hematology panels fit into the equation? Is it an urgent care center? An emergency department? What’s the cost? Is it waived?
These elements all have to answer the three questions around improved service, enhanced quality, and decreased cost. And when I say decreased cost, it’s not per unit. If you can demonstrate reduced length of stay and it’s not pie-in-the-sky fluff, you’ll get an audience. Stick to the basics, answer the three questions—not two—and people will give you the business.
Jim Richter, what is your reaction to what Stan said? What efforts have you seen at Roche to answer his three questions?
Dr. Richter (Roche): I love Stan’s questions for their clarity and succinctness. I would add that in the world of digital pathology, particularly when we think about specific use cases or early adoption, there isn’t clear data or a business case for reimbursement and return on investment, which means we might not get to have that conversation with Stan because I may be able to answer only the first two questions. However, our customers are also telling us they are changing how they evaluate ROI for digital pathology. They are widening their scope to consider how the technology can bring them more customers, grow business with existing customers, and how it can retain and recruit pathologists in this tight market, which is only expected to get more difficult.
A visionary approach to digital pathology is not just the digitization of images and the FDA clearance of primary diagnosis, although that is an entry point. Roche continues to evolve and improve on our digital pathology system—scanners, image management systems, and monitors—as well as the larger digital enterprise with offerings like Navify Clinical Hub, which is about data management within a health care environment. So it’s not just about pathology images but also a focus on clinical laboratory data, analytics, and data management.
Roche’s perspective is this is a growth enterprise and we’re looking for scalable digital solutions that are in an open and interoperable environment that goes beyond glass and slides and toward the larger laboratory management of clinical data.
Digital pathology goes hand-in-hand with your efforts in companion diagnostics—we’re talking about solving service issues for patients and for their physicians, correct?
Dr. Richter (Roche): Yes. Stan made a point around service and acknowledging we are woefully understaffed with pathologists and other laboratory professionals in clinical laboratories. That ship is not going to turn around soon. There is going to be a dependence on digital and AI solutions, perhaps despite the expense, as a way to fill a growing need. AI also has the potential to be much faster, opening the door for laboratories to do more with a smaller staff than they may have had in the past. As the companion diagnostics and biomarkers world gets even more complicated, if the capacity is not coming from trained pathologists, it will need to come from digital and AI solutions if we are to continue to meet the growing needs of patients and providers.
Alex Cameron, Siemens understands that systems are at the service of the patients’ physicians and has worked to make it easier on a health system to operate its gear, regardless of where it is. Can you elaborate on what that means?
Alex Cameron (Siemens Healthineers): Yes. Stan’s challenge to industry is service and quality at lower cost. For our Atellica portfolio, our goal from an engineering and service standpoint is simply to require less from the laboratory. One of the best embodiments of that is our Atellica Integrated Automation. Labs need automation, but not all labs can fit it in and most can’t afford it. So we decided to take the components of automation that most impact service, quality, and cost and shrink the footprint, make them lower cost and more attainable, and build them into a wider range of workflows. When it comes to having an impact on the things Stan mentioned, we’ve seen a 25 percent reduction in emergency department turnaround time with the integration of our Atellica Integrated Automation, an 84 percent decrease in risk for error with onboard automated QC, and a 54 percent decrease in manual steps required for QC each week, meaning less labor. It’s a sort of inverted thought process that has come to dominate how we think at Healthineers. It’s about the need for a lab to do less to achieve its goals when it’s under more pressure and in more demand than ever before.
Sarah Harrington, what are your thoughts on what you’ve heard so far?
Dr. Harrington (Hologic): Hologic has been a leader in cervical cancer screening for several decades. This has allowed us to build strong relationships with our customers and design products to address their needs. Our Genius Dx was built as a solution to a problem that labs face. Many labs have a high Pap volume and there are fewer cytologists and the cytologist’s role is expanding beyond just screening. The Genius Dx takes the hundreds of thousands of cells on a Pap cytology slide and uses an artificial intelligence algorithm to create a gallery of clinically relevant images that can be signed out efficiently and accurately. In Hologic’s clinical trial, there was an increase in disease detection with Genius Dx compared to manually reviewed slides. There are also efficiencies to be gained in reducing the movement of glass around a laboratory. If a lab has multiple campuses or locations, they’re waiting for courier slides—all that goes away with automation. That’s why we started with a high-volume test with gynecological cytology, but as we expand our AI menu in the future, it becomes a platform for others.
Are we getting ever closer to an autonomous operation of basic Pap testing?
Dr. Harrington (Hologic): We’re not at the stage where it’s a black box into which you put the slide and it spits out the answer. Instead, we believe combining the expertise of the cytotechnologist and pathologist with the AI provides the best result.
Alex Cameron, does the staffing shortage, from phlebotomists to pathologists and PhDs who have to make important decisions for patients and counsel physicians, continue to be a driver of the innovation you are pursuing?
Alex Cameron (Siemens Healthineers): Yes. Innovation at Siemens Healthineers is not about just better instruments; it’s about reinventing the lab, because with this trend of reduced labor, in all disciplines and departments, we have to engineer the automation of routine tasks and free up folks to work on what matters most. To retain talent and attract new talent to the field, people have to be able to do things that directly impact patient care by providing value and meaning. That’s why within our automation and analyzer portfolios, we’ve looked at a family of solutions to find ways to automate routine tasks. In addition to the Atellica Integrated Automation, we also are a leader in total lab and task-targeted automation. Across a network and a variety of laboratories, we can tailor fit automation to solve the lab’s unique needs and help address its unique labor challenges. To address an issue of this magnitude, you must have tailor-fit solutions, which we focus on in our automation portfolio.
Stan Schofield, can you speak about what members of the Compass Group face? As the managing principal you have excellent insight into what they need. Tell us what you’ve heard and anything else you’d like to add.
Stan Schofield (Compass Group): The Compass Group just had a successful meeting and continues to grow—we added four health systems as members this week. The need is to solve the staffing problem through equipment and technology because the training programs are not working. Everything around where the specimen is that has a human who touches it is open for technology solutions. I saw an interesting example where blood is drawn from a patient in the emergency department and tubed directly to the analyzer in the core lab, where the instrumentation handles everything. No one picks up the tube, uses sneaker power to walk it across from processing to spin it, split it, and then load it on a machine.
You’re on the right track about solving personnel problems. We’ve been having shortages for 15 to 20 years, but they’ve continued to grow with no replacement cycles. And the technology being introduced is five years too late for what we need. We were talking about companion diagnostics 15 years ago and we’re just getting into them now. We have to move faster into more autonomous, less complex operational excellence.
The labs are struggling. Some proactive labs in the Compass Group are fine but almost everyone has shortages around anatomic pathology, cytology, and phlebotomy. Microbiology is getting there. Automation, more AI applications, fewer contacts, fewer decisions having to be made by people, and less maintenance will keep driving the laboratory to success because we don’t have the people.
Alex Cameron, automation and ease of use in high-volume settings must be a sine qua non in many cases as you look to develop new instruments and tasks, yes?
Alex Cameron (Siemens Healthineers): Automation is not just about high volume; it’s everywhere now. You need it across entire networks of labs, labs of all sizes. That’s why our focus on automation has been to think broadly across a family of solutions.
To the point about how we bring technologies to market now, instead of in five or 10 years, this is where we see the ability to impact labs through software. When we talk about artificial intelligence—at Healthineers it’s called enterprise intelligence—it’s about having data integration across workflows, instruments, and automation for more effective workflows, better analytics to understand what’s happening and how to improve the labs, and ultimately quicker and better decisions in the clinic.
Sarah Harrington, Hologic has an important line of tests for sexually transmitted infections. Can you tell us about developments in your assays?
Dr. Harrington (Hologic): We do a lot of customer research to ensure we’re making tests our customers need not only on the lab side but also on the clinical side. We rely on our customers’ feedback to best understand the current state of the market and what is needed from a clinical and laboratory perspective, and that applies throughout our entire diagnostic portfolio, whether it is STI or cytology.
It’s gone unremarked in surprising ways that almost every laboratory in North America of any size is now on an ocean of Epic installs and increasingly converting older lab information systems to Epic Beaker for integration into one large system. Fifteen years ago we would have been debating six varieties of LIS and how they fit your operation. That’s almost unheard of now. Stan Schofield, talk about what that means to a laboratory operator.
Stan Schofield (Compass Group): For 25 years, we had best-in-class LIS. It usually handled the billing and the blood bank. Over time Epic developed Beaker. Ten years ago, it was rudimentary—it worked great in a doctor’s office but not in a big regional lab. Five years ago, Epic enhanced the capabilities so it was hitting about 90 percent of the needs of a regional lab. We were asked why we didn’t use Beaker. It was a pretty easy argument—we didn’t want to put our sizable outreach program at financial risk because Epic doesn’t have what we considered a state-of-the-art billing module, they didn’t have the blood bank, and the hospitals and health system were busy optimizing and integrating.
During the pandemic, more consolidation of the system took place as well as single-signature governance of the health system. It became evident to the IT executives that there’s this $5-, $6-, $10-million bogey outside of the Epic charges. Then the real pressure began—“We’re not paying this extra money” and “We don’t want two systems; we won’t support extra platforms.” The IT people convinced the CEOs that one system was the best. That has driven rapid change. When that happens, you have to evaluate the figures, cost, and structure. And at the end of the day everyone said, Epic Beaker is free. You should switch. Well, it’s not free, but on a 10-year window it can be more cost-effective once you get it up and running. The problem is, you have to switch. No one has enough consultants and experts to switch to Epic Beaker, so you have to hire high-cost consultants. As a result, labs forced to go to Epic Beaker have tough decisions. Where are you going to get $6 to $8 million to do the transition and cost transfers and build the system? What are you going to do about your billing and blood bank systems?
Beaker and Epic have disrupted the LIS industry. Best-in-class companies for their LIS are cut in half, if not more. And the future is, it’s Epic and you’d better make it work. Even if it’s 90 percent effective, the health systems will say, “That’s good enough. You figure out the details.” And we are. Every lab I know that has to go to Epic drops everything except for day-to-day operations for two or three years because they don’t have the bandwidth to do anything else.
Alex Cameron, in an environment in which all eggs are increasingly in one basket, how do you account for that in your strategic planning?
Alex Cameron (Siemens Healthineers): When it comes to responding to labor shortages, adapting to the lab’s future needs and embracing automation and technology are crucial, but know-how—how you design, implement, and support—is just as important. As a vendor of automation, we think about how we do workflow design and health care consulting and how we provide service and support, just as much as we focus on the products. When you’re dealing with, for example, the challenges that may arise from a particular software system, we have the know-how to do that. You can’t dump these things on labs. It’s a partnership. That’s been a big differentiator for us.
Sarah Harrington, that’s one more task diagnostic companies have to take into account—you have to pay more attention to IT and middleware offerings than you might have had to 10 years ago. Is that true?
Dr. Harrington (Hologic): Yes—take LIS as an example. In anatomic pathology, there are still many different LIS vendors and customizations. Epic Beaker is a major player, but many still have their own homegrown LIS. This is particularly true in private reference labs. So it really comes back to being a partner across all aspects of the laboratory, whether it is IT, applications, service, et cetera, and being flexible to what your customers need. Before even implementing the Genius Dx at a lab, we work with the lab to ensure we have addressed all aspects of their IT concerns to ensure as smooth an implementation as possible.
As we go forward, there will be many more challenges with cybersecurity, LIS integration, things where the labs need us to help and we need to be a good partner and help find solutions and work together. One size never fits all.
Jim Richter, Roche has made a large commitment in the past few years to Navify. Tell us about that.
Dr. Richter (Roche): We are continuously looking to provide innovation, value, and utility. We take the approach of “doing now what patients need next” as a trusted leader in diagnostics. New technology, customer service, technical support, and hiring new talent for Navify digital pathology have been essential to responding to in-lab LIS technical challenges. Having a talented workforce and pivoting when customers and the market require it is essential to innovation. As a dependable partner with many touch points and connections within the pathology lab, we will continue to lead with tools and solutions that bring value to our customers.