Q. Now that both bloodstream infection panels are FDA-cleared, what does this complete portfolio allow QIAGEN to offer US laboratories that they couldn’t get from the platform before?

The big change is that U.S laboratories can now use QIAstat-Dx for a much broader range of bloodstream infections. The two complementary panels cover 33 pathogen targets and 28 antimicrobial resistance markers, delivering results in about one hour.

This enables laboratories not only to diagnose the cause of an infection but also to deliver information that is increasingly important to optimize treatments and manage bloodstream infections better. 

Bloodstream infection testing is now part of a broad infectious disease testing menu that also includes respiratory and gastrointestinal infections as well as meningitis and encephalitis.

From a laboratory perspective, this means being able to perform a wider range of infectious disease testing on a single platform with a standardized and familiar workflow. From a clinical perspective, especially with bloodstream infections, speed matters as these infections can become serious very quickly. Getting relevant and more comprehensive information about a patient’s infection faster can support clinicians to make more informed treatment decisions.

Q. For a clinician dealing with a suspected bloodstream infection, how could getting a result in about an hour change the way they approach treatment?

For patients with bloodstream infections, and especially those at risk of sepsis or septic shock, time is a critical factor. Sepsis can progress rapidly to organ dysfunction and death if effective therapy is delayed, making early access to actionable diagnostic information extremely important.

The QIAstat-Dx BCID panels are designed to provide clinicians with this information quickly and shorten the diagnostic gap by identifying pathogens and detecting key antimicrobial resistance markers directly from positive blood cultures in approximately one hour.

Clinicians get relevant information about an infection earlier in the process, allowing them to make more informed treatment decisions sooner. When a resistance mechanism is detected, therapy may be escalated more rapidly to ensure appropriate coverage. On the other hand, in situations where broad-spectrum treatment is being used empirically, a rapid result may support earlier de-escalation to a narrower therapy. In both cases, the goal is to move from uncertainty toward more informed treatment decisions sooner.

This can be especially meaningful among vulnerable patient groups such as intensive care unit patients, transplant recipients, oncology and hematology patients, and neonates. These patients often have ahigh risk of severe infection and may benefit most from rapid identification of both pathogens and important resistance mechanisms.

A single diagnostic test does not determine patient management on its own, but identifying pathogens and resistance markers quickly can still accelerate the pathway from empiric treatment to targeted therapy. 

This is where the value lies: Giving clinicians actionable information earlier when time matters enormously to support better-informed patient care.

Q. What have you heard from laboratories and clinicians about the need for faster information on both the infection itself and possible antibiotic resistance?

We are hearing consistently from laboratories and clinicians that they are looking for three things: faster pathogen identification, earlier visibility into antimicrobial resistance, and solutions that are practical to implement in real-world healthcare environments.

We saw this in our Early Access Program in Europe that allowed select sites to evaluate how the BCID panels could fit within routine laboratory workflows. One of the recurring themes was speed. Laboratories and clinicians need to receive actionable information fast Traditional microbiology workflows provide highly valuable information, but they often require multiple sequential steps before a complete result is available. During that period, clinicians may be managing critically ill patients without yet knowing the specific pathogen causing the infection or whether important resistance mechanisms are present.

Another strong message was ease of use. Laboratories want a solution that can be implemented into laboratory routine easily and used outside traditional laboratory operating hours when highly specialized expertise may not be immediately available.

Participants also highlighted the value of combining pathogen identification and resistance marker detection within a single test. If clinicians deal with a serious bloodstream infection, knowing what pathogen is present is important, but knowing whether it carries a resistance marker that could affect treatment adds another piece to the puzzle that supports more timely clinical decision-making.

Customers also raised the question of accessibility. Many healthcare institutions do not have advanced microbiology capabilities on site, send samples to central or reference laboratories once a blood culture becomes positive. This can add time when it is the most critical factor. So, customers are interested in bringing clinically relevant pathogen and resistance information closer to the patient, supporting earlier treatment decisions while conventional microbiology workflows continue.

Those are exactly the needs we had in mind when developing the BCID panels: speed, relevant resistance information and a workflow that can be used in a real laboratory environment.

Q. With antimicrobial resistance becoming a bigger concern, how important is it for QIAstat-Dx to provide resistance markers alongside pathogen identification rather than treating them as separate tests?

It is very important because this approach reflects how clinicians think about infections in practice. The critical question is often not simply, “Which pathogen is causing the infection?” but rather, “Which pathogen is causing the infection, and what resistance mechanisms might affect treatment?” 

The QIAstat-Dx BCID Plus AMR Panels were specifically designed with this objective in mind. While conventional microbiology workflows ultimately provide answers to these questions separately and sequentially, QIAstat-Dx panels look for pathogens and key antimicrobial resistance markers in a single test. This gives laboratories a more complete picture earlier in the diagnostic process.

However, I want to be clear about what this does and does not do. The BCID panels complement standard microbiology workflows rather than replacing conventional culture and susceptibility testing. But they can provide actionable information earlier and support earlier treatment optimization and antimicrobial stewardship efforts, while conventional tests continue. 

We expect this kind of information to become increasingly important over time. Resistance patterns continue to evolve, influenced by factors ranging from antibiotic use and regional epidemiology to healthcare practices and global mobility. That increases the need for diagnostic information that supports not only diagnosis but also treatment decisions and antimicrobial stewardship.

Q. QIAstat-Dx now has more than 5,200 placements globally. What are you learning from laboratories that are already using the system, and how is that feedback shaping the next stage of the platform?

One of the clearest lessons is that laboratories look at the whole testing experience, not only look at the assay itself. They care about how ease of use and time to result, but also about which additional insights a test provides, whether the menu can grow with their needs and how connectivity can help to share information across different stakeholders within the hospital or lab.

This customer perspective is important to us as we develop QIAstat-Dx further. One priority is to ensure performance and reliability as the platform and menu evolve. 

Another is continuing to expand and differentiate our testing menu and accelerate results reporting to better support patients, especially critically ill and immunocompromised groups. 

We are looking at how connectivity, Artificial Intelligence and clinical decision-making tools can help customers better interpret patient results and AMR determinations, in close connection with electronic health records.

Ultimately, this is how we see the next phase of QIAstat-Dx: ot innovation for its own sake but making the platform increasingly useful in everyday clinical practice.

Q. Looking beyond this latest FDA clearance, where do you see the biggest opportunities for QIAstat-Dx and QIAGEN’s infectious disease testing business over the next few years?

Looking ahead, I see the biggest opportunity for QIAstat-Dx in expanding the range of infectious diseases we can address and providing clinicians with more information about antimicrobial resistance.

One area we are building on We are developing an advanced panel for gastrointestinal infections with additional clinically relevant targets and enhanced reporting capabilities. 

We are also working on enhanced version of our meningitis/encephalitis panel for the U.S. market that enables the detection of additional viral targets. 

The third area, and an especially important one, is antimicrobial resistance testing. The bloodstream infection panels have brought AMR detection into the QIAstat-Dx portfolio, and we want to build on this approach and further expand this part of the testing menu. 

Our pipeline includes syndromic panels for complicated urinary tract infections (cUTI) and pneumonia that will combine pathogen identification with antimicrobial resistance information. There are currently no syndromic testing solutions available for complicated urinary tract infections, which are frequently associated with resistant pathogens. 

Our complicated urinary tract infection panel has received FDA Breakthrough Device Designation, reflecting the unmet need in this area. Our aim is to develop a panel that accelerates time to appropriate treatment for patients suffering from these infections. 

Overall, infectious disease testing is increasingly about giving clinicians not only a faster answer to the question “What is causing the infection?”, but also earlier information that can help them understand what they may be dealing with from a resistance perspective. For QIAstat-Dx, our focus is on expanding that type of clinically relevant information across a broader range of infectious diseases.