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DATE

Thursday, May 7, 2026 at 9:30 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Thierry Bernard
  • Vice President, QuantiFERON — Nadia Albrecht
  • Chief Executive Officer, Inpeco S.A. — Riccardo
  • Head of Product Portfolio and Innovation — Nitin Sood
  • Head of R&D Applications, QuantiFERON — Parampal

TAKEAWAYS

  • Latent TB Testing Market Size -- The addressable latent tuberculosis (TB) testing market is estimated at approximately 75 million tests annually, with a 4%-5% annual growth rate and a projected market value of $1.6 billion in 2026.
  • Skin Test Conversion Rate -- 40% of global latent TB tests have shifted from traditional skin testing to modern IGRA (interferon-gamma release assay) solutions, leaving 60% of the market available for further conversion.
  • Automation Partnership -- Qiagen N.V., DiaSorin, and Inpeco are developing a purpose-built, fully automated QuantiFERON IGRA testing platform, with expected laboratory deployment in late 2027.
  • CLIA 2 Chemistry Launch -- The new LIAISON chemistry (CLIA 2) increases lab throughput by up to 75% and reduces turnaround time by 25% versus the prior version, launched in Europe in November 2025 and in the U.S. after FDA approval in February 2026.
  • AI-Enabled Risk Stratification -- Qiagen N.V. is building an artificial intelligence tool for patient-level TB progression risk, leveraging a data set of 13 million de-identified longitudinal clinical records, targeting a release in 2027.
  • QuantiFERON CD4/CD8 Platform -- The only latent TB test combining CD4 and CD8 T-cell immune response detection, designed for higher sensitivity, especially in immunocompromised populations.
  • $600 Million 2028 Revenue Target -- Management reaffirmed its €600 million QuantiFERON revenue goal for 2028 but cited a $30-$35 million headwind from the loss of the U.S. immigrants testing market.
  • Customer Transition Feedback -- Adoption feedback on CLIA 2 chemistry has been described as "overwhelming" and no customer has expressed dissatisfaction with its efficiency gains.

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RISKS

  • Management identified a $30–35 million revenue shortfall from the loss of the U.S. immigrants latent TB testing market, specifically impacting growth.

SUMMARY

Qiagen N.V. (QGEN 2.70%) detailed an expanded automation strategy through a joint platform with DiaSorin and Inpeco, purpose-built for QuantiFERON testing and targeting late 2027 implementation. The company introduced a new CLIA 2 chemistry in both Europe and the U.S, designed to increase patient throughput and reduce turnaround time, with customer adoption progressing according to plan. An AI-enabled risk stratification tool is in active development, leveraging proprietary longitudinal data to enhance individualized latent-to-active TB progression prediction, with a targeted 2027 launch. Management acknowledged a tangible revenue headwind from the U.S. immigrants testing segment but remains committed to long-term growth targets amid market expansion opportunities and further conversion from legacy skin tests.

  • Nitin Sood said, "only we can build this intelligence into the test—this risk-based progression score—because only we have access to these 30 million patients that have longitudinal data," positioning the AI solution as unique to Qiagen N.V.
  • An estimated 2 billion people globally have latent TB, highlighting extensive market potential not yet fully addressed.
  • The new automation platform is tailored directly to QuantiFERON workflows and will not be compatible with competing latent TB blood-based tests, supporting exclusivity and differentiation.
  • Management noted adaptability, maintaining offerings through existing Tecan and Hamilton partnerships for lower-volume users while the new Inpeco solution favors high-throughput labs.

INDUSTRY GLOSSARY

  • IGRA (Interferon-Gamma Release Assay): A blood-based diagnostic test to detect latent tuberculosis infection by measuring immune response to TB antigens.
  • CLIA 2 Chemistry: The next-generation LIAISON laboratory chemistry enabling greater patient throughput and shorter turnaround for QuantiFERON testing on DiaSorin analyzers.
  • QuantiFERON: Qiagen N.V.'s proprietary blood-based test for latent TB infection, notable for its CD4/CD8 T-cell dual-detection capability.
  • CD4/CD8 T-cell Response: Immune markers measured in certain TB assays, with their combination increasing diagnostic sensitivity, especially in immunocompromised patients.

Full Conference Call Transcript

Thierry Bernard: Thank you, Dominica, and good morning, good afternoon, good evening, to all of you. Thanks again for your attention and interest in Qiagen N.V. A year ago, and I hope and I think that most of you attended that event, we organized an investor relations deep dive session on QuantiFERON. And we wanted to leave you with three main messages. One, tuberculosis is still the main infectious disease killer in the world. Remember, tuberculosis continues to kill more than HIV and malaria every year. About 1.6 million people die every year of tuberculosis. But the reservoir of latent tuberculosis is an even greater health care challenge. Two billion people in the world are estimated to be impacted by latent tuberculosis.

This is an incredible number. Second, Qiagen N.V. is the undisputed leader for more than 20 years now for latent tuberculosis testing. But despite being a leader, we have never been complacent or arrogant, and we have continuously invested into the development of our solution. First, if you remember, back in 2016, the front-end automation and the unique partnership with a leading company in immunodiagnostics, DiaSorin. Second, the continuous improvement of our test itself, the kit and its chemistry, bringing the only combination—I repeat, only combination—on the market of CD4 and CD8, which is so critical to be able to manage specific populations of patients, for example immunocompromised patients. Think about HIV patients, hepatitis patients.

QuantiFERON latent TB testing is by far the most sensitive test on the market. Third, after the automation of the back end of the test with DiaSorin, the automation of the front end of the test with partners like Tecan and Hamilton, two leading companies again. The third message we wanted to leave you with a year ago was the market potential is still significant, especially the market conversion of skin tests, an antiquated technology. And we told you that the best estimation today is that we still have around 50 million skin tests in the world ready to be converted to a more modern approach like Qiagen N.V. QuantiFERON.

Just in the U.S. alone, it is 15 to 16 million skin tests to be converted. But we do not want to stand still. Today, we are coming to you to announce that three leading companies are either strengthening or creating new collaborations to bring an even better set of solutions to our customers. First, DiaSorin, our partner for almost 10 years now. Second, a leading company in full engineering and automation, Inpeco, and we will have their CEO, Riccardo with us today. Third, Qiagen N.V., of course, continuously investing into our solution. First, new innovation—and you heard about it, at least in Europe—an unprecedented improvement of the efficiency of our current test. Turnaround time is of use.

We call it CLIA 2. Already available for some months in Europe, now available as well in the U.S. Second innovation: today the first and probably only end-to-end automation—sample in, result out—automation for QuantiFERON. For the first time, two companies together with DiaSorin are bringing the first full automation workflow where a technician will just need to put a tube into the system and wait for the result. And third, a unique and clearly only possible for Qiagen N.V. because of 20 years of test data, a unique AI investment to help doctors determining tomorrow who in the whole population of latent TB patients has the highest score to move to active TB. This is tremendously exciting.

This is innovation at its best, but it is also confirming that Qiagen N.V. does not take our leadership with complacency.

Unknown Speaker: Thank you, Thierry. Innovation clearly does not stop here. And with that, let me hand over to Nadia Albrecht, who is going to tell more about our unique QuantiFERON ecosystem.

Nadia Albrecht: Hello everybody, it is great to see you at this QuantiFERON Spotlight event.

Nadia Albrecht: WHO has announced that by 2035, they would like to eliminate tuberculosis. You can only eliminate tuberculosis by working on your active TB cases and treating your patients, but you should also look for the reservoir. And this reservoir is latent TB or TB infection. Twenty-five percent of the world population, or about 2 billion people, are infected with latent TB. Qiagen N.V. estimates the global latent TB testing market at approximately 75 million tests annually, growing about 4–5% per year. Only about 40% of this market has been converted from traditional skin tests to modern blood-based interferon-gamma release assays or IGRAs.

Patients that usually get tested are immunocompromised, healthcare professionals, people that live in close relationships with an active TB patient, but also other groups. All of this together makes a market potential of $1.6 billion in 2026. During our deep dive of QuantiFERON last year, we told you that we would continue to invest in our QuantiFERON portfolio. And this is indeed what we have done. From the beginning of the acquisition of Cellestis, Qiagen N.V. has non-stop invested in making our QuantiFERON assay better, more specific, more automated, and more reliable. When we launched our fourth generation, we added a patented CD4/CD8 antigen technology.

And this has allowed us to have a more reliable assay for critically ill patients like immunocompromised and HIV. The magic happens in the tubes. But we never stopped looking at how we can further improve the test. Today, we are proud to present our next-step workflow enhancement and the creation of a QuantiFERON ecosystem for improved automation and patient management. The first improvement is the launch of a new LIAISON chemistry together with our partner, DiaSorin. The new chemistry is designed to improve speed, throughput, and workflow efficiency by enabling labs to test up to 75% more patients per hour and achieving a 25% faster turnaround time compared to the previous version.

It was launched in November 2025 in Europe, and recently launched in the U.S. after receiving FDA approval in February 2026. The feedback of our clients is very positive, and we are on track in our conversion plan between the old and the new chemistry. Latent TB testing is moving towards higher volume, more automated workflow, as the market increasingly shifts from traditional skin tests to modern IGRA-based detection. Qiagen N.V. has been investing in automation for several years, partnering with companies such as Tecan and Hamilton to streamline pre-analytical steps, with DiaSorin to automate the detection on the LIAISON platform.

But we felt as the market leader that we had to go a step further and aim for full automation enabling labs to scale with growing demand. This is why Qiagen N.V., leader in blood-based latent TB testing, and Inpeco, a leader in lab automation, and DiaSorin, leader in high medical value testing, have started the development of the first fully automated blood-based IGRA testing platform that we plan to launch by 2027. Lab technicians will only need to load the samples and all the other steps in the process will be done automatically, in the right sequence and at the right time.

This is the first and only blood-based IGRA test for higher volume testing that will be fully automated.

Unknown Speaker: Labs face growing pressure, limited resources, rising costs, and increasing volumes. Efficient scaling of latent TB testing is essential. Three leaders meet this challenge: Qiagen N.V. with QuantiFERON, the gold standard in modern blood-based latent TB testing; DiaSorin with its LIAISON system and chemistry; and Inpeco with deep expertise in laboratory automation. Together, they are creating a fully integrated QuantiFERON ecosystem from sample to insight. The workflow starts with one simple loading point. Whole blood samples can enter as a single tube or as a set of four QuantiFERON tubes. From there, the system creates a continuous flow from sample to result. Each sample is identified, processed in sequence, and tracked in real time.

This supports traceability, compliance, and stronger process control, while reducing manual touch points and the risk of handling errors. A key innovation is the dedicated QuantiFERON aliquoter. It is purpose-built to handle the four QuantiFERON tubes required for each patient's sample. By automating this step, the system supports consistent tube handling while preserving QuantiFERON's clinical performance, led by CD4 and CD8 immune response detection. Once blood is mixed with the antigen-coated tube, the science of QuantiFERON begins. T cells are activated, triggering the CD4 and CD8 responses at the core of QuantiFERON's clinical strength. Measuring both responses supports the most reliable results across patient groups. The tubes then move into a purpose-built QuantiFERON Intelligent Incubation System.

Connected directly to the track, it enables continuous incubation instead of batch handling. This supports timing, controlled conditions, and a more efficient workflow. After incubation, samples move directly to the LIAISON XL system for automated detection. The seamless integration of incubation and detection enables continuous processing, removes delays, and helps laboratories improve turnaround times and productivity. Testing efficiently scales up with less manual work, lower operational complexity, and scalable growth. More automation, greater scalability, faster access to reliable results. This is the next generation of blood-based latent TB testing. A continuous automated ecosystem built around the power of QuantiFERON.

Unknown Speaker: With this partnership, we are leading again the next generation blood-based IGRA testing. And we will have an automated proposal linked to the volume needs of our clients. Twenty years of experience, four generations of tests, multiple endorsements, and more than 2,700 publications. We are the only company that has this experience. Based on this, we are creating an AI-enabled risk stratification tool for TB progression with the goal of supporting stratification of patients at a higher risk of progression to active TB disease. With this tool, we are creating a real sample-to-insight QuantiFERON ecosystem.

This tool will use the values of our four unique QuantiFERON tubes, along with other parameters, to deliver a more complete view of the immune response to TB. The tool is built on one of the largest longitudinal TB clinical data sets, comprising about 13 million de-identified patient records, collected over the last 10 years, and is intended to support healthcare professionals in making more informed decisions, improving patient counseling, and supporting enhanced patient care. At Qiagen N.V., we non-stop continue to invest into QuantiFERON as we grow with our clients and we answer the needs of this growing business.

Unknown Speaker: Thank you, Nadia. And Nadia will also be here with us in the studio for the Q&A. Three topics: detection, automation, and AI-enabled risk stratification. Thierry, let us focus for now on automation. And for that, I would like to welcome the CEO of Inpeco, Riccardo.

Thierry Bernard: Yes. Indeed. We have Riccardo with us and it is an honor, Riccardo, to have you with us this morning. Let me start with the first question. You are a leading company in engineering and lab automation. Explain to us why end-to-end automation is so critical for customers these days?

Riccardo: So first of all, Thierry, hi. And thanks for this invitation. I think we are all proud to announce this joint impactful innovation. So to answer your question, let me start from our vision. We as a company believe in a world where medical errors are eliminated through lab automation, software, and data traceability. We all know today labs are facing what is called a perfect storm: chronic shortage of skilled staff and a massive increase in testing volumes. End-to-end automation is, in our view, the best way to solve this. By removing manual touch points, we reduce the potential for errors and ensure full traceability from the moment a sample arrives until the final result.

This allows labs to scale their operations efficiently while guaranteeing the highest level of clinical integrity.

Thierry Bernard: That is very good. And Riccardo, if I may, I have a second question for you. Like us, like Qiagen N.V., you work every day with the biggest labs in the world, the Quest, the Labcorp, the Cerba in the world. Why do you think a purpose-built full automation for QuantiFERON would make sense for those kinds of customers?

Riccardo: Yes. Thanks, Thierry. I mean, it makes a lot of sense because, you know, laboratories today serve a massive spectrum of needs—from small specialized labs to large centralized facilities that you mentioned—with an increased sample volume. The challenge is how do they scale operations and reduce manual steps simultaneously. This is exactly where I see our partnership makes a difference. Inpeco is not just providing a track to Qiagen N.V. We are integrating a full automation for the entire diagnostic workflow through our flagship automation, the FlexLabX, with new dedicated modules and software.

So by combining Qiagen N.V.’s leading detection capabilities that we have seen with our DNA in automation, we are creating a truly integrated and fully automated solution for QuantiFERON latent TB testing.

Thierry Bernard: That is really exciting.

Riccardo: Output is increased, dependence on staffing is reduced, you know? And let me say, more importantly, it creates a super standardized, repeatable process that brings long-term value to the health care system and the labs across the globe.

Thierry Bernard: That is really exciting. I think, Dominica, that you had another question for Riccardo as well.

Unknown Speaker: So one last question from my end, Riccardo. From an investor's perspective, and I think they will be very interested in that, by when do you think the first systems will be up and running at our customers?

Riccardo: Nadia, it is our commitment to move with the greatest momentum to bring this next-generation system to the market. Our ambition is to have the solution fully up and running in laboratories in late 2027. And now we are in a phase where, obviously, we are also understanding if this can be anticipated. But the forecast is late 2027. Thanks for asking.

Thierry Bernard: And the good thing, Dominica, to leverage a bit what Riccardo just said is that we have already under CDA presented together with Riccardo, or sometimes separately, the solution to some key customers. And what I can testify today is that the reception and also the input from those customers have been fantastic.

Unknown Speaker: Thanks. So as you have seen, we now also are joined by Nadia in the studio. Welcome back.

Nadia Albrecht: Hello, Dominica. Hello, Thierry.

Unknown Speaker: So we are ready now for the Q&A. And taking your questions will be Thierry and Nadia from the studio. And we also have some more speakers for you today. Welcome back, Riccardo. And we also have as a speaker, Nitin Sood. You know him from our last events, Head of Product Portfolio and Innovation. And we also have for you ready to take your questions, Parampal, who is the Head of R&D Applications, QuantiFERON. Before we start, just as a quick reminder, if you have not done so, please type in your questions into the Q&A box in the web portal. And we are very happy to take them. And I think we are ready for the first question.

Right? So let us start with the first one. Are there any competitors currently offering end-to-end track-based automation for latent TB testing? And how differentiated is QuantiFERON's position in that area?

Thierry Bernard: Well, the answer is very simple, Dominica. It is no. First of all, even as of today, with the current workflow—Tecan or Hamilton, QuantiFERON and DiaSorin—there is no comparable automation. And tomorrow, this will be unique and really specific to QuantiFERON. So the answer is clearly no. It is, at the moment, unprecedented.

Unknown Speaker: So the next one—you expect, sorry, it jumped. Give me a second. There are lots of questions coming in, that is good. That is why it is jumping, so apologies for that. Do you expect an impact of AI-enabled decision support on testing volumes or market expansion?

Thierry Bernard: Well, I am going to ask Nitin that question because, obviously, you understand that we are taking a bet here. It is a very well-considered bet. It is a fantastic evolution because the holy grail in the fight against TB will be that ability to detect or to predict—predictive biology—who in the population of latent TB has the most risk to go to active TB. So what do you think, Nitin?

Nitin Sood: Yeah. I mean, I think, first of all, I just want to emphasize the fact that only we can build this intelligence into the test—this risk-based progression score—because only we have access to these 30 million patients that have longitudinal data. And, you know, again, just want to remind everyone that most people who have latent TB do not have active symptoms and may not follow through with their treatment. And therefore, providing this intelligence to the patient or to the physician will increase compliance to treatments. And that is a big differentiator, and we absolutely hope that will allow us to expand our leadership position in the LTBI franchise.

Unknown Speaker: So the next one is on the partnership with Inpeco. The development of end-to-end automation solution—is it purpose-built for QuantiFERON?

Thierry Bernard: It is, but I would like to invite also Riccardo to give his vision here.

Riccardo: Yeah. Thanks for this one, Thierry. So while our history is completely rooted in open automation, this project has been ideated and will be developed with and for Qiagen N.V.’s specific workflow. So we are developing a new aliquoter, which is specific to the testing as you have seen in the video, and an intelligent incubator that has been designed from the ground up specifically for the QuantiFERON test. So this level of specialization, which is incorporating Qiagen N.V.’s specific configuration and workflow design, is exactly what allows us to guarantee the high level of throughput and error reduction, which is also defining our mission.

So that is why we are prioritizing the integrity of the specific test to ensure the highest standard of patient care. And that is why this automation and workflow is specific for Qiagen N.V.

Unknown Speaker: Yeah. So the next one is on partnerships, right?

Unknown Speaker: So what drove the decision to partner with Inpeco versus Qiagen N.V.’s prior automation partners such as Tecan and Hamilton? What is the value? And this next one is on AI. Let us keep it for now on Tecan and Hamilton.

Thierry Bernard: On Inpeco, I think it was a choice that became very clear to us when we decided not to think about automation in terms of adding some different instrument, but thinking from scratch and saying, why do we not build something purposefully for our test? And therefore, Inpeco, a company that we have known for so many years—and we knew that, guess what, they were present where we are present, are present in our biggest customers, we see them every day—it was a natural partner.

Unknown Speaker: Let us now move to the AI question. So the value of AI-enabled risk stratification, and which segments of the testing market would this be most relevant for?

Thierry Bernard: I think first we should probably give a bit of science with Parampal on what we are trying to achieve, then I will ask Nadia to take that question on specifically the patient population that we are targeting. Parampal?

Parampal: Thank you, Thierry, and, well, hello, everyone. I want to say a few things. I am so excited to say this. Qiagen N.V. has acquired 13 million unique de-identified patient data sets, and Qiagen N.V. is the only company that has this breadth of testing, and these data span from 2017 onwards. So it is almost a decade worth of data. And the key here is the longitudinal data. That means that the patients have to be tracked over time, and we need to have full history of multiple QuantiFERON tests and all other patient parameters which go with the testing to diagnose the progression from latent TB to active TB.

And the value of CD4 and CD8 is so unique to Qiagen N.V. because it gives the comprehensive view of the immune response. These patients are already sick and they could be immunocompromised, and this is what advantage the QuantiFERON test brings to the table. So that being said, these data sets are spanning all geographic distribution of the U.S. It has pediatric to geriatric population, which is so important for the TB disease. And this will allow us to have a full comprehensive view of immune response for patients at the individual level.

We already know that these risk factors are determined at a CDC and WHO level at a population level, but the key is what about the patient level? And that is the beauty of this risk score, risk stratification tool which we are bringing to the table.

Thierry Bernard: Thank you, Parampal. Nadia, can you say a word about what kind of patient segments would be even more interested?

Nadia Albrecht: Yes. Thank you, Thierry. For the patient segments, according to the guidelines in the U.S., every latent TB patient needs to be treated. As Nitin already said, if you are not sick yourself and you need to start a treatment, sometimes it is difficult to convince the patient to be treated. So this is why we hope this tool can help a clinician to show to their patient the added value of getting a treatment and why it should be done. So, in principle, it is going to be done for all patients that a clinician sees.

We know that some people are very at risk—you know, if you take biologics and if you are immunocompromised, these very high-risk patients—but it is really to convince a patient: please follow your treatment and finish your treatment and do not stop it because this is surely not good.

Unknown Speaker: So we have a couple more on AI. Maybe we stick to that for a moment. Institutional organizations like WHO, migration offices, and so on will probably be very interested by the AI tool. Have we already started to discuss with them and what is the input on that?

Thierry Bernard: I would say that Qiagen N.V. is first and foremost a fact-based company. So we try to avoid making claims as long as we are not clearly sure that what we are seeing, what we are bringing to the market, is proven. And so before having those organizations—WHO, Stop TB—introduced, we prefer to have even better data, deeper data, and then we will engage them. But you know, those are partners of Qiagen N.V. for so many years. Remember back in 2015 when WHO stated that latent TB was a key asset in the fight against active TB, it was after discussion and work with Qiagen N.V.

Unknown Speaker: Then to stay also again with the AI tool, a question is when is the launch date? Let us be a bit more specific on the software for predicting tuberculosis, and also is it exclusively for QuantiFERON/DiaSorin customers who can benefit from that AI risk stratification tool that we are launching?

Thierry Bernard: I would invite Nitin to take that question. Nitin, on the approximate launch date and on which kind of workflow we want to adjust that tool.

Nitin Sood: Yeah. I mean, again, the tool is very specific to QuantiFERON because, again, it requires both CD8 and CD4. And it requires access to this longitudinal information that we have collected now through this 30 million data points over a decade. So very specific to us. I also just want to highlight that we have a very cross-functional team working on this. You know, we have experts in AI, experts in the QuantiFERON chemistry, clinicians or medical experts also working with us. So it is a very cross-functional effort. And the goal is to get the tool out as quickly as possible. We are targeting 2027 for the launch of this tool.

Unknown Speaker: So Nitin mentioned CD4/CD8, and we have a question around that. What advantages does a CD4/CD8-based latent TB test have?

Thierry Bernard: Nadia?

Nadia Albrecht: Yes. Thank you very much. So I am going to give the basics, and then afterwards, I am going to invite Parampal to continue. As a company, Qiagen N.V. decided to launch a fourth generation. We were already in the market for some time and we knew very well why we decided on this unique CD4/CD8 combination—because we wanted to improve and we wanted to put the standard again a little bit higher. So what we see today is, and we see this from all the publications that are out there, that with a combination between CD4 and CD8, you have a much more solid test and your results are much more reproducible.

So I do not know, Parampal, if you want to add something on the science part?

Parampal: Sure. Thank you, Nadia. So the CD4 T cells are available when there is a response against TB antigen. However, when there is a patient population which is immunosuppressed, their CD4 cell response could be impaired. In that situation, it is so important to have another T cell response marker, which is CD8, which allows us to look at more biologically relevant information in those patient populations which are high risk. And if you look at the TB case management, these are the groups who are more prone to progress from TB infection to TB disease.

This is why the combination of CD4 and CD8 allows us to have a more sensitive and specific test, which people can rely on, patients can rely on, clinicians can rely on, and the laboratories can rely on. So this is the uniqueness of CD4 and CD8, which has so much evidence available through publications, which allows us to really be proud as a culture to have a very strong test on the market.

Unknown Speaker: Thank you, Parampal.

Unknown Speaker: So now one question again on automation, which is, just to clarify, are we still offering—is there still a partnership with Tecan and Hamilton with the Inpeco system that we are going to launch?

Thierry Bernard: And we need to be clear. What is the power of automation? It is obviously ease of use, gaining time, gaining efficiency, cost efficiency, patient efficiency. But the power of automation is also in flexibility. It is not one size fits all. And therefore, we want to continue to offer the QuantiFERON as it is, the QuantiFERON on LIAISON—Nadia spoke about the conversion progressively to the CLIA 2 on LIAISON. Some customers are only sometimes interested in the front end. And they are used to work with Tecan; it is going to continue. The same with Hamilton.

Some customers will say, I will take care of the front end, I have the technicians for that, and I just want the LIAISON automation. That is perfectly fine. It depends on volumes. It depends on throughput. It depends on the countries. But something I would like to ask also Nadia to highlight is that even our full automation with Inpeco will be flexible.

Nadia Albrecht: Thank you very much, Thierry. Indeed. So we really need to give an answer to the needs of the smaller customer or to a higher-volume customer. And I think a lot of people, if they see Inpeco, we have different possibilities: the two—the aliquoter—and we have our incubator. An aliquoter will be needed if a customer works with a one-tube format. An aliquoter will not be needed if a customer works with a four-tube format. So this is already a tailor-made solution. You have an incubator; depending on the volume you are going to have a day, you can put in multiple incubators one beside the other.

And you could, in principle, also build on a current track that is already available in labs. So we really go for a tailor-made solution because when a customer wants to go for automation, we make a group, we sit down with the customer and we make, together with Inpeco, together with DiaSorin and us, a tailored proposal to the needs of the customer, also keeping in mind that sometimes customers can grow. So if a customer would grow in their volume, there is always a possibility to add an extra LIAISON instrument or to add an extra incubator.

Unknown Speaker: And on volume, customers who would benefit from an end-to-end workflow, from an end-to-end automation—is it more targeted to high-throughput customers? So just maybe a bit more color on that.

Nadia Albrecht: Yeah.

Nadia Albrecht: So it is really targeted for what we call our high-end customers. But do not be blind, this is not only U.S.-based customers. Worldwide, we have quite a lot of customers that have a possibility to go into this automation process. These are customers that today we would like to serve in a way that is unique in the market.

Unknown Speaker: Okay. Now jump back to AI. We have a couple more AI topics. Why does risk stratification matter? And is it not the point to treat all patients, and just what is the added value for that?

Thierry Bernard: Because we tried to explain, especially also a year ago during our deep dive, that when you have such a reservoir of potentially active TB—we said 2 billion, a quarter of the world population, which means probably that in this room, there is someone who is latent TB positive—we like it or not, but that is the way it is. Two billion people.

It is clear that from cost management, from a personalized medicine standpoint, having the ability to detect or to predict who among those with latent TB has the highest score to go to active TB—therefore needing a specific follow-up, a longer treatment, a specific attention and a complete adherence, because that is the problem many times with the patient, they do not comply sometimes with their treatment—is key. It is key. Many companies have been trying, and Qiagen N.V. as well, with different technologies for many years to get there. With protein-based solutions, with genomic-based solutions. It failed all the time. And suddenly, we realized, wait a minute. This company has multi-years of multiple results.

And we have also acquired other health care data and now we are creating those algorithms.

Unknown Speaker: So now, let us see. Let us take a financial one in between. It is on our 2028 target of $600 million. What gives us confidence in that? And also, how are the new launches contributing to that?

Thierry Bernard: So that is a very fair question. Back at our Capital Markets Day in 2024, we set the target of €600 million, as we said, Dominica, for 2028. We were very transparent a week ago to the market as well that if all the other applications on QuantiFERON are growing in a healthy way, we suffered the loss of one market, especially in the U.S. and in some countries in the Middle East, but mainly in the U.S. It is the immigrants market. And we gave the market very clear indication: we believe it is between $30–35 million of impact.

We still believe that because of the potential of new applications, not only with what we are launching today, but existing immediate opportunities—testing for patients under dialysis, for example; extending the knowledge around, for example, the connection between diabetes patients and latent tuberculosis—that we have ways to mitigate. But at the moment, let us execute on our target for this year. Let us execute on coming back to growth we can confirm in H2. And we will come back with the appropriate target. What I keep in mind is that the market to convert is still significant. This market is still growing.

It is a good market to be in, and we have more and more solutions to address it completely.

Unknown Speaker: And, yeah, on the conversion rate of the market, we keep saying 40% already converted. What do we need to get this conversion rate above 50% and even higher? And how might new entrants impact this conversion dynamics?

Thierry Bernard: Nadia, do you want to take it? Yes. I will chime in after if you want.

Nadia Albrecht: So on the conversion rate, it is a combination between our sales teams, our clinical demand teams, but also our medical teams. Because Thierry just mentioned that there are new groups of patients that have the possibility to be tested. And this is really where our medical affairs does a huge, solid job. So our teams have strict criteria. We follow up, we go to patients, and we continue repeating the same message.

Key messages if you want to convert a skin test to a blood-based IGRA test are: everybody who is BCG vaccinated will quite often be false positive with a skin test, so you cannot really deal with it; secondly, when you do a skin test, people need to come back twice. So these are the messages that we continue saying, and we see year after year that a big part of the market is shifting. Some parts of the market have almost shifted 100%. If you look at biologics, biologics is almost using blood-based IGRA tests and QuantiFERON tests for all of their patients.

If there is a new company coming into the market, this new company together with us can move the 75 million that is today the market of latent TB up to 80 million, up to 90 million because, as Thierry just said, there are 2 billion people with latent TB. So the number of 75 is much higher because in some countries, not everybody is tested. In addition to that, I would like to add that back in 2016, when we deliberately chose DiaSorin as a partner, it was a very well-thought choice. DiaSorin is not just an immunoassay company. DiaSorin is a leading company in esoteric, added-value medical tests.

Their salespeople, like Qiagen N.V. salespeople, are used to spending five, six, seven visits to convert customers. We like it or not, health care is very prone to innovation, but there is a lot of conservatism. So for example, in the U.S., we have a tool, a marketing tool—and I discussed that with the market over the last three years—enabling us to know by ZIP code where the remaining skin test customers are. And then once we have the information, we look at what kind of population are they basically serving, immunocompromised or not, and we try to convert them. But it takes some time, up to six, seven visits.

It is fair to say that it takes on average seven visits to convert, not because they are not convinced—they are—but because they are comfortable with the way it works. “My technicians are trained,” and little by little, you go to medical value, you go to cost efficiency, and they move to you. That is a natural movement, but it takes time. It takes time. It takes medical, and it takes experience and mindset. This is why DiaSorin was not just an option among many, it was the option to partner efficiently with us.

Unknown Speaker: Let me bundle a couple of questions on the Inpeco system.

Unknown Speaker: So oh, it is moving again. So where do you find Inpeco systems, and what type of labs are these new call points for QuantiFERON? Are there customers that have seen this? How is the response of customers?

Thierry Bernard: So I will quickly say I am going to move to Riccardo because nobody can speak better about where Inpeco is in the world, but yes, obviously, the major labs in the world are all customers of QuantiFERON as we speak. Obviously, we have visited already some of them, a fantastic attention. They saw the workflow, also suggested some improvements. And it is work ongoing. It is very exciting to see the level of interest, the fact that they come back to us: when is it going to be available? We already have customers saying, I want to be the first one to implement it. But, Riccardo, what about the presence of Inpeco all over the world?

Riccardo: Yes. Thanks for this one, Thierry. So we are present almost in every country in the globe. We have currently around 3,000 automation tracks installed worldwide. I think the important message is that, you know, obviously, we are perceived as a company working in the high-end segment of the market—you mentioned Quest, Labcorp; all the biggest labs across the globe have our automation—but 80% of our automations are in the smaller type of labs. Because, I was hearing Nadia loud and clear, obviously you are now targeting the high-end segment. There is a huge portion of the market that is not only looking just for efficiency gains, they are also looking to really remove tedious manual operations.

So these kinds of labs are really in a search, in a quest, for end-to-end automation. This is where I see our partnership coming together. Global leader in lab automation, the global leader in latent TB testing, coming together with the, as you said, super-performant analytical platform like the LIAISON from DiaSorin—I really think we are bringing something really impactful fully to the market. And we have a huge market to target. As I said, 3,000 installations across the globe that can plug in this new solution from our three companies.

Thierry Bernard: Thanks, Riccardo.

Unknown Speaker: And on the DiaSorin chemistry: what is the feedback from customers? Are we seeing any faster adoption or transition to LIAISON? And how did this address any hesitation in conversion?

Thierry Bernard: So we have given numbers today. Nadia can repeat them. And yes, the reception in Europe is very good, but we just got approved by the FDA in the U.S. So we are currently introducing the test to the customers. But Nadia,

Nadia Albrecht: Thank you very much, Thierry. So the feedback of the customers is really overwhelming because we know it goes faster. We have a faster time to detection. We can do many more patients. And what is ongoing now is we are in a transition plan. This transition plan is really followed up extremely correctly. We have not had one customer that was not pleased with the results of CLIA 2. So we are following the conversion plan and we are convinced that it will be done on the timing that we have foreseen.

Unknown Speaker: And now the last one for today. So the full automation workflow—can it also be used with other blood-based latent TB tests, or is it really just available for QuantiFERON?

Thierry Bernard: I think we did answer, but it is a good question. It is a key question. We did answer—Riccardo and I—and Nitin said a word also about this. It is a purpose-built automation for QuantiFERON. I believe that if those partnerships want to be winning partnerships, there needs to be a kind of—call it exclusivity or call it special relation—but something very strong. Basically, we like the fact that Inpeco is so specialized in very precise automation. We like the fact that DiaSorin is so specialized in esoteric testing, and that makes that specialization and that depth of partnership—because we all have skin in the game—makes this partnership potentially successful.

Unknown Speaker: And with that, we are at the end. So any closing remarks?

Thierry Bernard: No. I would like to take advantage of Nitin being with us—he is heading our portfolio development—to give his vision as concluding words. And obviously, thank Riccardo, thank Nadia, thank you, Dominica, thank our IR team. But Riccardo, thanks a lot for being with us, and thanks also to DiaSorin and Ivette. If they are not with us today, thank them for this partnership. Nitin?

Nitin Sood: Yes. Thank you, Thierry. So I hope what all of you saw in today’s program is not just a product update. It is an ecosystem. That is what we are building, and we are building that from a position of strength. So three things. First, we are making the test faster—75% more testing with CLIA 2. Number two, we are making the test fully automated—no manual steps. And number three, we are adding intelligence to the test, on the basis of 13 million patient records that no one else on earth has. That is ecosystem leadership. That is what today is all about. Thank you.

Unknown Speaker: Thank you, Nitin. And with that, we are at the end of the spotlight. Thank you for your participation. Hope to see you soon again. And if you have any remaining questions, please always feel free to contact us. Happy to help you. So see you then. Bye.

Unknown Speaker: Qiagen N.V. Sample to insight.