If you were explaining Curetis to someone who is not familiar with the organization, how would you characterize its primary areas of expertise? Curetis’ Unyvero System helps provide a comprehensive diagnosis of severe infections in hospitalized patients much faster than conventional methods. This supports an early and informed decision on which antibiotic therapy is most suitable for the individual patient. The ultimate goals are to improve outcome for the patient, lower the treatment costs per patient, and prevent misuse of antibiotics.
What are the major categories of solutions that Curetis provides for its customers? Curetis’ Unyvero Solution allows complex molecular diagnostics with unprecedented ease of use, allowing for fast and precise diagnosis—for example, pathogens in close proximity to the point of need. Our current tests focus on pathogen panels and antibiotic resistance markers in severe pneumonia as well as implant and tissue infections.
With Unyvero, Curetis has developed a unique system that fully integrates and automates molecular diagnostics directly from native patient samples. What used to be done in a specialized laboratory with multiple manual handling steps or large pipetting robots, sometimes taking days, can now be done in a compact cartridge without expert knowledge in molecular biology methods—even outside the laboratory. Within a few hours, the patient sample can be probed for hundreds of different nucleic acids in parallel.
Curetis currently has two CE Marked diagnostic cartridges that are commercialized in Europe—the Unyvero P55 for the detection of pneumonia and lower respiratory tract infections and i60 ITI for implant and tissue infections. Because of Unyvero’s high multiplexing capabilities, the system lends itself to many further applications with high impact on clinical decision making—whether in infectious disease management with diagnostics currently in development or in other areas such as companion diagnostics, oncology and beyond, in the future.
What is the state of the art for the use of molecular methods to diagnose infectious disease today? Where might this technology be heading tomorrow? Currently, most molecular infectious disease testing, for viruses like HIV, HCV, and HPV, for example, happens in specialized molecular diagnostic laboratories using real-time PCR. While this technology is sensitive and can be applied in a quantitative way, the ability to multiplex is rather limited. Hence, while this technology is good for screening for a specific pathogen, it is challenging to obtain the full picture of a microbial infection that could be caused by numerous pathogens, some with acquired resistance to common antibiotics. Also, turnaround times in classical microbiology culture are usually two to three days—too slow if patients suffer from acute microbial infections and require immediate medication with adequate antibiotics. Driven by this medical need, the IVD industry is experiencing a strong trend toward developing solutions that allow for fast and easy-to-use molecular testing of larger test panels close to the point of need.
Beyond individual diagnoses, what implications does such testing have for population health management, response to pandemics, combating antibiotic resistance, or other broad health issues? There are several implications beyond the immediate medical benefit to the individual patient. Just to name two: treating a patient with the right antibiotic from day one likely results in shorter hospital stays and fewer complications. Thus, there is a potential to treat the patient in a more cost-effective way with economic implications for the hospitals as well as the entire healthcare system. Further, a more informed and targeted use of antibiotics earlier in therapy is one important measure to slow the increase of ever-growing resistance to antibiotics in the population as a whole—which is widely regarded as a major global health crisis.
Can molecular methods “coexist” with traditional culture-based microbiological testing? Do both have a role? Both approaches have their specific benefits. Traditional microbiology detects the presence of living bacteria and functionally assesses antibiotic resistance. Molecular testing is much faster and often detects additional pathogens that escaped the traditional approach. Also, if permitted by the multiplexing capabilities of the molecular method used, quite broad pathogen and resistance panels can be tested fast and efficiently. While the traditional microbiology culture will remain standard of care for some time, the clinical community has started to appreciate that molecular testing can provide early and additional information, allowing for more informed decisions right at the beginning of the therapeutic intervention. Nevertheless, most clinicians will want to confirm their therapeutic approach with culture.
With Curetis’ Unyvero System advancing toward FDA approval, the company seems poised to increase its footprint in the United States. What timetable do you foresee for its expansion into the U.S. IVD market? We are currently running the trial for a planned 510(k) submission of the Unyvero system and Unyvero LRT55 cartridge for lower respiratory tract infections. We expect to finalize patient enrollment by mid-2016 for a 510(k) submission in the second half of 2016. Without preempting the decision of the agency, we will likely start building the first U.S. commercial operations with the hiring of key staff around the time of submission. If successful with our 510(k) submission in the typical timeframe the FDA requires for review, we expect to launch the Unyvero System with the LRT55 application in the first half of 2017.
As Chief Commercial Officer, what do you see as your priorities going forward? We are still in the early days of leveraging the full commercial potential of Unyvero. I strongly believe direct interactions with customers are crucial when introducing innovative solutions into IVD markets.
Because of this, our commercialization strategy includes direct sales in German-speaking countries and selected European markets such as the U.K., France and BeNeLux. Our focus in these markets is on convincing the relevant medical communities of the advantages and merits of Unyvero, but we also seek to incorporate feedback from these early adopters and key opinion leaders, and broaden the evidence base for our product jointly with our customers. This will require a further building of our commercial capabilities in Europe in the coming months and years.
Beyond the markets we directly serve, another priority is to identify further appropriate partners to broaden global commercialization. We work with these partners to garner swift regulatory clearance and launch Unyvero in their respective geographies.
Beyond commercializing Unyvero for routine clinical use, we are experiencing an increasing interest by pharmaceutical companies with antibiotics in clinical development. To this end, we recently started to provide Unyvero Systems and P55 cartridges to clinical trial sites of an ongoing phase III trial of a novel formulation of the antibiotic amikacin to facilitate and speed-up patient enrollment. While we handled these requests rather opportunistically in the past, I believe that these partnerships hold great potential not only for creating a benefit for the pharmaceutical partner, but also introducing Unyvero into clinical routine.
Finally, I believe that Unyvero as a molecular diagnostics platform for highly multiplexed decentralized testing holds great potential for applications beyond infectious disease testing and even beyond human diagnostics. For now, Curetis is exclusively focused on commercializing applications for severe infections in hospitalized patients, but we plan to explore partnering opportunities in other areas.
