August 2025—Werfen launched in July 2024 its Gem Premier 7000 with iQM3 blood gas testing system. One year in, CAP TODAY publisher Bob McGonnagle spoke with Werfen’s Kristina Powell, Ken Huffenus, and Sofia Afonso for the latest on that and about what Werfen showcased at the ADLM meeting last month.
Kristina Powell, tell us how acute care diagnostics is going and in particular about the adoption of the Gem Premier 7000 with iQM3 since its release last year.
Kristina Powell, director, worldwide marketing, acute care diagnostics: The Gem Premier 7000 is the first and only blood gas system with integrated hemolysis detection at the point of care. This is truly a breakthrough in blood gas testing, helping to uncover the “hidden problem”: Hemolysis, which is prevalent in acute care settings that utilize whole blood testing, has largely gone undetected until now. Since last year we’ve had an incredible amount of interest in the Gem Premier 7000, which has resulted in impactful research, such as recent publications from Prof. Giuseppe Lippi of the University of Verona, Italy, on the potential impact of the Gem Premier 7000 on blood gas testing and the improved patient safety derived from the timely identification of hemolyzed samples and spuriously elevated potassium values in point-of-care settings [Pighi L, et al. Clin Chem Lab Med. Published online May 22, 2025; Pighi L, et al. Clin Chim Acta. 2025;574:12035; Pighi L, et al. J Med Biochem. 2025;44(4):915–918]. Additionally, a key multicenter study from our early adopters in the U.S. has confirmed that hemolysis is common in point-of-care settings and the prevalence rates in emergency departments, ICUs, and NICUs shared in the literature are applicable to whole blood specimens referred for blood gas testing [Farnsworth C, et al. Clin Biochem. 2025;138:110955].
At ADLM this year we hosted an educational event on the impact of hemolysis in the emergency department and the partnership that’s needed to prevent it and ensure continuous quality. We are creating advocacy and have solutions to not only acknowledge the problem, but also to help enact change to address the problem and improve the situation.
With the variety of users of the Gem Premier 7000, there is usually an identifiable champion. Are they coming more from the laboratory or the ED or elsewhere?
Kristina Powell: Champions are coming from all over. The laboratory has been vocal about hemolysis at the point of care for a long time. Decades ago laboratorians did not want to have electrolytes, particularly potassium, reported at the point of care because they understood the prevalence of hemolysis and that there were no safeguards at the point of care, until now. We have heard from early adopters of the Gem Premier 7000 in EDs, NICUs, and other clinical settings that their clinicians are becoming key champions because they recognize its importance for patient management, the impact of hemolysis on potassium results, and the need to have quality results or understand when quality is potentially compromised. This is fundamental to the way they work.
Ken Huffenus, what in the hemostasis area was emphasized at the ADLM meeting?
Ken Huffenus, director, worldwide marketing, hemostasis: We presented the ACL Top Family 70 Series, a new generation of the ACL Top Family, at the ADLM meeting this year. It takes the quality and efficiency of the original ACL Top and ACL Top Family 50 Series systems and expands its ability to connect across a network of multiple sites and hospitals. With the ACL Top Family 70 Series, we’re reintroducing HemoHub Intelligent Data Manager, specialized for hemostasis. The combination of the two creates a powerful new product offering that expands connectivity across the network. With each new generation, we’ve added new and unique features to continuously improve our legacy, market-leading, standardized ACL Top family we introduced two decades ago.
Are there tests or features of the instrument itself that distinguish the ACL Top Family 70?
Ken Huffenus: Yes. First, one model in the ACL Top Family 70 Series, the ACL Top 970 CL, brings chemiluminescence testing to the ACL Top Family for the first time. We’ve had the ACL AcuStar with important chemiluminescence tests for many years, but now we have an integrated system that offers chemiluminescence testing along with all the traditional clotting, chromogenic, and latex immunoassay hemostasis testing on the same platform. The first assay we’ll introduce on that platform is the anti-PF4/heparin IgG antibody testing for heparin-induced thrombocytopenia, which was recently FDA cleared.
Additionally, we looked at overall lab workflow and found areas of opportunity for verification studies and lot management. As an example, labs can now run both lots onboard the ACL Top Family 70 Series—not possible in the past—and perform all required testing at once. With HemoHub Intelligent Data Manager, everything needed to perform analysis of lot-conversion data can be automated, and final reports can be generated automatically. Regarding accreditation and compliance, we hear from our customers that the burden of documentation almost dominates their work. They’re spending more time on that than on running samples and investigating patient issues, so the ACL Top Family 70 Series assists them in addressing this and have more time to focus on their patients.
I’m assuming one of the hotter issues in large core labs is what to do with coagulation. Some people want to put it on the general line, but that is not generally considered the optimal solution. So you’re increasingly making converts to your approach.
Ken Huffenus: Exactly. We started our journey years ago with a lab automation connection on the ACL Top Family, but we quickly understood the value of a specialized lab automation workcell for hemostasis to optimize workflow and quality. So HemoCell Specialized Lab Automation was developed and has gained tremendous traction, especially in North America recently, from people who were staunchly in the total lab automation camp. HemoCell meets not only routine but also specialized testing needs, and maintains platelet-poor plasma too. These are areas that TLA vendors don’t necessarily focus on. And HemoCell can meet tight turnaround-time goals with a level of specialization and customization, with both hardware and software, that focuses on complex rules and autovalidation for hemostasis, which TLA vendors also can’t offer.
Additionally, we have a suite of workflow analysis tools that allow a fully customizable and optimized approach, and even a virtual reality tool that allows our customers to visualize what their lab will look like with their custom-designed HemoCell workcell.
Sofia Afonso, you have an important autoimmune business. Can you tell us what was seen at the ADLM meeting in that area?
Sofia Afonso, director, worldwide marketing, autoimmunity diagnostics: One of the big highlights was our Aptiva multianalyte system, which now includes 18 FDA-cleared analytes, with antiphospholipid syndrome being the latest. Powered by PMAT [particle-based multianalyte technology], Aptiva delivers high-throughput, multiplexed testing with impressive precision, helping address the complexity of autoimmune disease diagnosis and giving labs and clinicians a more complete and reliable tool. We also showcased Integrated Lab+, our end-to-end solution that brings together advanced systems, novel assays, lab data intelligence, and specialized services. It’s designed to help labs run more efficiently, reduce turnaround times, and ultimately improve patient care.
A standout moment for us was hosting an educational event focused on the real-world impact of autoimmune diseases. Lupus patient and advocate Seda Bryant shared her powerful story of delayed diagnosis; she was followed by a panel of experts who explored how Aptiva’s PMAT technology can support earlier, more accurate detection. It was a meaningful reminder of why early diagnosis matters, and why we are committed to advancing innovation and awareness in specialized autoimmune diagnostics.
Is there anything you’d like to add that hasn’t come up yet?
Kristina Powell: As we’ve rolled out the Gem Premier 7000 and are introducing Werfen to new institutions for blood gas testing, we’re finding an interest not only in solving the hidden hemolysis problem, but also in solving unmet needs related to staff efficiency that we designed the Gem Premier platform to address—all-in-one, multiuse cartridge, no maintenance, and a quality management program designed to never need intervention from laboratory or clinical staff. And we’ve received amazing feedback on our outstanding customer support. These are basics that we, as an organization, have taken for granted because that’s how we live and breathe. But many institutions that haven’t worked with us before aren’t familiar with the myriad benefits of our blood gas testing systems and how we collaborate and partner with our customers, and that’s resonating.
Ken Huffenus: A final comment that also applies to all of Werfen is our focus on improving the cybersecurity of our instruments and digital solutions. We’re actively engaging with hospital IT directors to understand their needs and ensure our products address those needs and continue to do so, as cyber threats constantly evolve. This is of the utmost importance to us and our customers.