July 2026—Roche’s new Cobas Mass Spec solution will be on display this month at the ADLM meeting, as will Diasorin’s new Liaison Nes, Siemens Healthineers’ Atellica DT 250, and much more. CAP TODAY publisher Bob McGonnagle spoke online in late May with representatives of Roche, Diasorin, Sebia, and Siemens Healthineers about how their instruments will solve some of laboratories’ pressing problems. The conversation follows.
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Instrumentation is an ever more critical variable in the equation for clinical laboratories. We have a shortage of senior laboratory technologists, scientists, and pathologists, and the onus to help people optimize efficiency and service is on what manufacturers offer in their instrumentation—automation, ease, convenience. Breakthroughs are going to be important for the future of labs. We also know laboratory work is increasingly done within large commercial labs or integrated delivery networks. Greg Stock, do you agree that the contribution of instrumentation is increasingly important for laboratories?
Greg Stock, MBA, senior vice president, Americas, Sebia: Yes. Automation continues to be more critical every year for the reasons you mentioned. We’re seeing in the market both centralization and decentralization at the same time. Given reimbursement cuts, staffing shortages, inflationary pressures, and aging expertise, the role of fully automated scalable solutions has become increasingly important. Labs continue to consolidate, so the big labs are getting bigger and midsize labs are increasingly challenged to survive. At the same time, simple benchtop solutions are moving closer to the patient for time-sensitive testing, while high-throughput systems are critical for centralized labs performing high-volume routine and specialized testing. Artificial intelligence will be increasingly incorporated into instrument software to improve accuracy and expedite test results.
Aigars Brants, PhD, director of scientific affairs, Sebia: I agree. When laboratorians historically thought of electrophoresis, they typically visualized very manual processes including pouring gels, preparing buffer, setting up equipment, and waiting hours for results. Technology has evolved significantly by the introduction of semiautomated gel platforms and fully automated capillary electrophoresis systems.
We’re now moving toward interpretation assistance. Our tests require time for review because it’s not only numbers; you have to look at patterns and also clinical history. In the future, laboratorians will be able to not only automate the manual processes, but also interface the systems and leverage software assistance to interpret results.
Annanya Shetty, tests and instruments seem to be in a constant migration from the central laboratory to the point of care and back again. Some have been through two or three generations of moving back and forth; I’m sure you’ve seen that at Diasorin.
Annanya Shetty, PhD, senior product manager, global marketing, Diasorin: The strategy at Diasorin has been how to address patients where they present for care. Bringing testing closer to patients is critical. The overall strategy for testing, especially as it relates to respiratory or infectious disease testing, is how to address the current challenges of lab staff shortages, having a limited pool when it comes to reimbursement, and payers not willing to pay for large multiplex panels. How do we address these challenges by having targeted assays or tests you can do at a decentralized outpatient clinic, and then reflex tests to a central lab with the option of having a larger customizable or flexible panel. You don’t want to test for 20 targets if you don’t need to given that the reimbursement landscape has changed.
Also important is ensuring the decentralized test is reliable and trusted so you’re not having to repeat in a centralized lab the same targets or analytes you’re testing for. At Diasorin we’ve thought about testing along the continuum of care for the patient.
Sophie Belin, tell us about the new Atellica DT 250 and the solution it offers as it relates to what we’re discussing.
Sophie Belin, head of Syva drug testing, Siemens Healthineers: Automation is important, but we need to keep in mind that simplicity is everything and without simplicity the innovation doesn’t really matter. With the Atellica DT 250 analyzer, we’ve tried to simplify drug testing. We started this project a few years ago with the voice of the customer; we asked what we needed to improve. The first topic was simplicity. These instruments are in clinical and nonclinical settings, where users are not always scientists, so the instrument needs to be easy to operate and intuitive. The Atellica DT 250 is an intuitive platform; you can be trained in four hours. There are many guardrails, so errors are minimized. With drug testing you need to be knowledgeable about the different cutoffs—is it qualitative, semiqualitative? We tried to make the software user interface specific to that but easy to use.
We also wanted to build in features to improve efficiency. It’s all automated, and we designed it with modern cybersecurity and privacy regulations in mind so people can feel confident patient data are secure.
Will it be available for examination at the ADLM Clinical Lab Expo?
Sophie Belin (Siemens Healthineers): Yes. This year is the first time we are showcasing it as a commercial product in the U.S. We launched it with drugs-of-abuse testing, and we are launching now the therapeutic drug monitoring menu. Next year we plan to expand the menu beyond what we had on the legacy platform.
I mentioned at the start that we are interested in breakthroughs. Roche has a major entry in several categories, one of which is a sequencing solution unique to Roche. Donald Mason, tell us about the mass spectrometry instrument we’re so excited about.
Donald Mason, senior marketing manager, mass spectrometry, Roche: Mass spectrometry has historically sat at the perimeter of laboratory medicine and been largely relegated to reference laboratories and the largest academic medical centers primarily because of its operational complexity, the lack of a commercial solution, and the need for highly trained technologists to operate the systems. The clinical chemistry community has long called for a more highly automated and integrated mass spectrometry platform capable of behaving like a clinical chemistry or immunochemistry analyzer, where samples are placed on the analyzer and results are received on the other end, including data interpretation. The Roche Cobas Mass Spec solution aims to achieve integration of sample pretreatment, chromatography, and mass spectrometry and, importantly, data reduction and interpretation in an unattended, hands-free manner.
While the Cobas Mass Spec solution will bring many higher-volume tests to market, there will always be a complementary need for mass spectrometry in areas like urine drug testing, where the entry of new illicit drugs into our ecosystem will likely outpace an IVD manufacturer’s ability to keep up.
Can you comment on the features in the Roche offering that will overcome some of the worries about ease of automation that have lingered over mass spec for the clinical laboratory application?
Donald Mason (Roche): One of the bottlenecks in today’s mass spectrometry-based workflows is sample pretreatment. While efforts have been made to automate sample pretreatment, whether by solid-phase extraction on a liquid-handling robot, liquid-liquid extraction, or other sample-preparation technologies, it is still semiautomated at best. An innovation Roche is bringing to market is the use of paramagnetic particles in the sample pretreatment process, which allows us to produce, onboard the analyzer, a highly enriched and clean extract that is then moved automatically into the liquid chromatography portion of the instrument. The introduction of these paramagnetic particles, or super beads as they’re affectionately called, relieves the bottleneck.
Another bottleneck has been data reduction and interpretation—taking a raw chromatogram, producing a numerical result from it, and ensuring quality metrics for the sample have been met. Quality metrics are things like relative retention time in your chromatogram, the ratio of the qualifier ion to quantifier ion, and a variety of others that are measured. Reviewing each chromatogram has historically required a trained data interpretation or data analysis technologist. We’ve automated that process by using a combination of existing technologies and machine learning that allows us to confidently reduce those data to a numerical result and release them to the LIS automatically.
The third bottleneck has been the lack of standardization in mass spectrometry, which has led to a need to calibrate assays on a per-batch basis. In today’s typical workflows, a series of calibrators is run before every batch of specimens on the analyzer, which is not an efficient use of the instrument. Roche is dedicated to developing reference measurement procedures for every assay brought to market on the Cobas Mass Spec solution, which allows us to implement a radically simplified calibration procedure that mimics what is done on our existing clinical chemistry and immunochemistry analyzers. For each of our assays, we will supply a leading calibration curve that will be electronically loaded onto the system. That calibration curve is adjusted using a simple two-point calibration performed typically once a month by the end user. We’re going from customers running as many as 120 or more calibration samples per month to running two a month. It’s dramatically simplifying and reducing calibration overhead to allow the system to run more efficiently; be standardized across time, instruments, and patients; and operate in random access mode. There’s no need to gather samples and wait for a batch size that’s a sufficient number to run. Samples can now be analyzed as they come into the laboratory, and results can be reported in real time. And the system is designed to be integrated with Roche’s automation systems.
That’s an important point because people have asked me where this instrument is going to live. And will it be on the floor again at ADLM?
Donald Mason (Roche): It’s designed for use in a core clinical chemistry laboratory using existing clinical chemistry technologists in the lab.
Now that the Cobas Mass Spec system is available in the United States with a menu of seven tests, Roche will unveil the system at its booth during the ADLM meeting.
Sebia has a broad line of instrumentation and has acquired many companies. Greg Stock, can you summarize the range of your most important instrument solutions?
Greg Stock (Sebia): Sebia is a well-known leader in the multiple myeloma field, including reagents and instrumentation that are routinely used in labs globally. Over the past few years, Sebia has expanded into autoimmunity and infectious diseases through the acquisition of five companies—Arotec Diagnostics, Corgenix, Zeus Scientific, Orgentec, and Scimedx. These companies collectively add extraordinary capabilities and expertise to the Sebia organization and will position us well to compete in the growing field of autoimmunity diagnostics.
In the area of immunofluorescence technology, we’ve added full automation for liquid handling using the dIFine P30 instrument, along with AI-based assistance for result interpretation using the dIFine microscope. We have recently gained three new FDA clearances for IFA pattern recognition covering mixed connective tissue disorders, lupus, and vasculitis.
Another area of recent advancement is with random access instrumentation, such as Sebia’s Alegria Flash chemiluminescence-based system. With the Lean lab workflow concepts, labs want to get samples processed through their lab quickly, with fewer bottlenecks due to batch testing. Alegria Flash offers sample-in, result-out processing, helping labs quickly and accurately produce reliable results. We’ll display these systems at ADLM.
Autoimmunity seems to be a hot part of the market now. Are volumes expected to grow significantly?
Greg Stock (Sebia): Yes. Autoimmune disorders are disproportionately associated with women and the elderly. Given the aging population, we’re seeing an increase in autoimmunity awareness and testing. Enhanced diagnostic sensitivity and specificity are identifying cases that previously went undetected. Also, panel-based testing approaches are improving speed to clinical diagnosis, which is a major challenge especially in autoimmune disorders due to non-differentiated patient symptoms.
Annanya Shetty, customers have always had an appetite for solutions, but they face choppy seas in terms of approval for capital and expansion. Many customers sit in laboratories and don’t know if they are going to be a central laboratory or satellite laboratory. There’s also the ever-present concern around labor and in-house versus send-out testing. Tell us about the solutions at Diasorin that address some of these concerns.
Dr. Shetty (Diasorin): We have the Liaison Plex platform, which is our larger, customizable, syndromic panel that traditionally sits in a central lab.
In March we launched the Liaison Nes; we will have it on the floor at ADLM. It brings testing closer to patients. We’re seeing success with this product, especially in emergency departments within large IDNs, outpatient clinics, small physician office labs, and urgent care clinics. It is Diasorin’s first CLIA-waived product. Non-medical technologists can run the test. Training is minimal; we don’t have people go onsite to do training. It’s plug and play and integrates with a lab information system. Customers were saying they have a lab staff shortage, and physicians were saying they have 20 minutes or less with a patient. The turnaround time on the Liaison Nes is 18 minutes, and four targets can be identified with a single swab. Our customers are able to have an answer for patient treatment decisions while the patient is in the room.
Another ask from our customers was for a cost-effective solution with a mini panel and then to be able to do extended targets at a centralized facility where more trained professionals perform the testing. If we don’t have the targets you test for at the point of care—the targets on the Liaison Nes are COVID, flu A and B, and RSV—you can mask those four targets on the syndromic panel on the Liaison Plex and do extended targets for parainfluenza or Bordetella, for example.
The Liaison MDX platform is meant for niche assays, such as for tick-borne diseases. We thought about the continuum of care as well as what our customers were asking for in terms of speed, accuracy, and the diseases they wanted to test for.
Sophie Belin, Siemens Healthineers has similar initiatives to cover the spectrum of where testing needs to take place optimally. There was a wonderful presentation at the Executive War College on how millions of tests are never performed even though patients leave with a prescription for the test. Patients were being lost to follow-up because they didn’t get drawn and return. Can you speak to this, particularly in the area of drug testing?
Sophie Belin (Siemens Healthineers): Yes. The drug testing market especially is driven by local regulation, and it’s volatile in that substances are banned in some states and not others. There’s also mandates for testing in urgent care settings in some states. That’s why instrumentation is important—the whole solution we deliver to labs is key in supporting the health care system. We have a scalable solution to go from the rapid test, the cartridges, which is more at the point of care, so we can be close to the ED and can get results in three minutes once the sample goes into the cartridge.
Atellica DT 250 is for the midsize labs specialized in toxicology for drugs of abuse testing, therapeutic drug monitoring, or even immunosuppressant drug monitoring. For very high throughput, we have the Atellica Solution, Atellica CH, Atellica CI. We have the full spectrum of solutions from the point-of-care rapid test to those for midsize and high-volume labs that can be connected to automation, all with similar techniques and correlation among instruments.
Talk about what happens when hospitals, clinics, or doctors’ offices combine. They create a new network, and those networks continually develop—they get together, break up, find new partners. How do you as a company recommend customers think about standardizing equipment when these pairings come about?
Sophie Belin (Siemens Healthineers): We recommend they get standardized and run similar assays across the network to avoid discrepancy when the same patient goes into one hospital or facility and then into another. Correlation among the results is critical.
Another critical piece is the IT, because you need IT to orchestrate all of that. Standardization is key, but you cannot put the same instrument everywhere. It’s not one-size-fits-all. That’s why we are working on a solution that’s scalable from very low to very high volume. We have a site that does 130,000-plus samples in a day, and there’s still a place for the smaller benchtop instruments, especially when affordability of the solution is key.
Aigars Brants, we have systems and various labs getting together, breaking apart, founding new places. It could be difficult to stay standardized in those laboratory environments. What have you seen in your work at Sebia that helps address concerns for standardization?
Dr. Brants (Sebia): Within electrophoresis, we are dealing with different platforms, different needs, and different tests. Some assays are not available across all platforms. Networking and information sharing among laboratories and facilities becomes critically important.
I am often surprised by how disconnected, or perhaps fragmented, the health care system remains and how laborious it is to obtain relevant clinical and laboratory information. One example is therapeutic monoclonal antibodies. They are prescribed and administered, but laboratories are often unaware of their use, even though they can interfere with many ordered assays. Addressing this requires either specialized testing to exclude interference or direct follow-up between pathologists and ordering physicians.
The common issue is the fragmentation of data needed to interpret the results and the difficulty of consolidating that information. For many routine assays, interpretation is straightforward and relies on standard flags such as high or low values. However, more complex analyses, particularly electrophoresis interpretation, require integration of multiple data elements. These include historical results, free light chains measured on different platforms, and other complementary findings from other assays. We are working on solutions to help speed up interpretation.
Donald Mason, at Roche you have a long-established relationship with a great middleware company, Data Innovations. Will it be the middleware for the Cobas Mass Spec?
Donald Mason (Roche): The Cobas Mass Spec solution relies on the Navify suite of informatics products, formerly known as Infinity. A suite of Navify informatics solutions run on the system and allow it to integrate with the laboratory information system.
Greg Stock, as you oversee a big portfolio in North America, these must be pressing concerns as you seek to help standardize, automate, and harmonize the reporting of laboratory results for physicians and patients. It’s a daunting task. As Aigars said, we’re surprisingly disconnected. Can you give us your thoughts on this?
Greg Stock (Sebia): The integrated health networks do not have one standardized lab size for all their locations. For example, they may have many small labs, a couple of midsize labs, and one centralized lab. Manufacturers must consider offering scalability in automation, creating instrument families not only from a customer expectation standpoint, but also for regulatory reasons. The costs for clinical studies and clinically characterized samples are a high barrier to entry. When we gain regulatory approvals, we want to make sure we can apply those approvals across a family of automation, to provide scalable solutions for laboratories of all sizes.
Aside from the hardware, we must ensure software meets increasingly stringent cybersecurity requirements, offers a simple user interface, allows remote accessibility, and offers bidirectional interface to LISs to eliminate manual entries.
Sophie Belin, most laboratories want two of the same instrument because there is downtime and maintenance. Do you see that in your work in drug testing?
Sophie Belin (Siemens Healthineers): Yes, in drug testing and everywhere else in the laboratory. I agree with the stackability of instruments, but we don’t want to put in an army of instruments either because it brings more maintenance, staff, and cost. We need to find the right balance between redundancy and the number of instruments we place. But it is a trend we see.
A nonurgent care setting or facility that has drug program management, where it’s okay if same-day results are not provided, might go with only one system. This is why reliability is also important. With the Atellica DT 250, a top point on the drawing board was reliability with less than two unscheduled service visits per year.
Annanya Shetty, what is the situation for the IVD industry as we go into ADLM this year? Is it much clearer, much improved? Many of us remember how hectic it was as we came out of COVID. Can you give us a general view about where we stand today?
Dr. Shetty (Diasorin): I’ve been in the diagnostic space for more than five years, but I started as an academic and did a PhD in microbiology and infectious diseases. In the post-COVID world there has been an emphasis on the impact of the diagnosis on patient outcomes. IVD manufacturers have stepped up in thinking about what the health care needs are today. I think we’re going to hear a lot about automation and AI and how it plays into the diagnostics space.
Diasorin is thinking about how we ensure integration but in a way that does not break the workflow in today’s IDNs. We don’t want to have solutions in place that require a system to use something apart from Epic Beaker, if that’s where they see their analyzer agnostic information. We’d like to integrate into those instead of building something different and breaking their workflow. We’ve also thought about how we can partner with middleware solutions ahead of launch. With the Liaison Nes, we thought about building drivers ahead of the launch to make sure we enable the standardization of workflows.
We at Diasorin are putting emphasis on our digital strategy as it relates to diagnosis and what it means for physicians, customers, IDNs.
Donald Mason, your thoughts on where we are today in this journey post-COVID?
Donald Mason (Roche): I echo what Annanya said about AI. A high percentage of the talks at the Executive War College this year focused on AI. Health care system leaders are starting to think more about how AI is implemented into our life, including into the medical laboratory.
I’m looking forward to a return to innovation. We’ve spent many years responding to the pandemic; a lot of R&D dollars and resources were put toward our COVID response. I’m excited to see how innovation in laboratory medicine accelerates now so we can see some of these great new products come to market faster to better serve our patient population in all our spaces.
Greg Stock, give us a final comment and talk about what you feel you’ll be seeing at the ADLM meeting.
Greg Stock (Sebia): As Donald said, R&D investments shifting to something other than COVID diagnostics will be good for the future of health care. I have tremendous respect for the companies represented here that are changing the way medicine is practiced. On one hand, we compete, and on the other hand, we are 100 percent united in what we do and in our purpose. Competition is good for the market in raising the bar for clinical diagnostics. The vendors represented at ADLM are a perfect example of that. You see best practices, new innovations, and it challenges each of us to improve, not only in terms of clinical sensitivity and specificity but also in the way customers engage with our organizations.