INDUSTRY TRENDS

Curetis to Launch Multiplex MDx for Hospital Infections in U.S.

Molecular diagnostics firm Curetis (Germany) specializes in solutions to rapidly diagnose and profile antibiotic resistance for severe infections in hospitalized patients. The company currently has its Unyvero platform and four cartridge-based tests—for pneumonia, implant and tissue infection, blood stream-related infections, and intra-abdominal infections—commercially available in Europe.

DTET recently spoke to Curetis’ CEO Oliver Schacht, Ph.D., about the company’s plans in the United States, as well as the company’s comprehensive approach to defining test value.

Will the U.S. commercialization strategy be similar to that taken in Europe?

When we started the Unyvero endeavors in Europe, we started out one cartridge at a time with the pneumonia panel, the implant and tissue infections, eventually the bloodstream infections, and the intra- abdominal infections earlier this year. In the United States we do expect the clearance of the Unyvero system to coincide with clearance of the lower respiratory tract infection panel, which is basically very similar to European hospital pneumonia panel. The FDA has requested the label to say lower respiratory tract and we are subject to pending agreements with the FDA on label claim and clearance. We have guided towards up to 36 analytes in the U.S. version versus the 40 we have in Europe. The reality is that in the multicenter trial with more than 2,200 patients there are a few analytes with not enough cases to sufficiently validate them in a prospective trial. But, it does tell you that they are very rare and all of the important ones—the gram positive and gram negative bacteria and all of the key antibiotic resistance markers, the hospital superbugs—will be on there.

Similar to the European approach, the second U.S. product that we are planning is the invasive joint infection panel. It is a variant from the European implant and tissue infections panel. Basically, in the United States we are looking at a particular sample type, synovial fluid, both from prosthetic joints and from acute joint infections. It is not covering all of the sample types in Europe, which also covers diabetic foot ulcers, burns, and soft tissue infections.

The strategy here has been first-in-class products. Today there is no pneumonia or lower respiratory infection multiplex, polymerase chain reaction (PCR), sample- to-answer panel in the United States. Similarly on the invasive joint infection, there is currently not a multiplex PCR panel straight from synovial fluid.

It becomes a question of priorities, funding, and resources. We have not yet made a determination of what products three, four, and five will be, but it is safe to assume we will proceed with applications or assays we already developed and have some data from European trials. But, over time we can also have U.S.-specific offerings.

What is the timeline for commercialization in the United States?

For the first cartridge we are offering guidance that we currently expect an FDA clearance decision later in 2017. We have been in very close interaction with the FDA since submitting in January. It has been an interactive review and our goal is to deliver all answers to their questions in the coming weeks. For the invasive joint infection our goal is to complete trial enrollment and run the trial in 2018 with FDA-approval and launch more like 2019. Beyond that the question is how many trials can we run in a staggered fashion and that is about funding and resources.

What is the timeline for commercialization in the United States?

For the first cartridge we are offering guidance that we currently expect an FDA clearance decision later in 2017. We have been in very close interaction with the FDA since submitting in January. It has been an interactive review and our goal is to deliver all answers to their questions in the coming weeks. For the invasive joint infection our goal is to complete trial enrollment and run the trial in 2018 with FDA-approval and launch more like 2019. Beyond that the question is how many trials can we run in a staggered fashion and that is about funding and resources.

Will Curetis branch out from hospital infection testing?

There is so much more that these multiplex platforms can do—oncology, genetic testing, companion diagnostics, but as a small company you have to focus. From a clinical development and commercial standpoint strategically we have focused on hospital infections. There is a big enough problem in clinical hospital infections to keep us busy for years.

Aside from the technological feasibility what other considerations go into building out the company’s test pipeline?

Aside from the technological feasibility what other considerations go into building out the company’s test pipeline?

Just because a diagnostic is technically feasible, at the end of the day, that doesn’t mean it should be developed as a product. We are looking at unmet medical need and unanswered diagnostic questions that require testing for dozens and dozens of putative pathogens, whether bacteria, fungi, and down the road viruses, as well as the pattern of antibiotic resistance markers.

We are looking at things that suffer from the standard of care being microbiology culture that takes several days or sometimes weeks to complete. Of course, the markets need to be sizable enough and it has to answer a question that not only delivers medical benefit to patients and doctors, but it also has to deliver health economic benefit to the hospital customers to be a commercially viable product.

Curetis has been publishing comprehensive studies that assess tests’ impact from an economic point of view and recognize importance of sound antibiotic stewardship. Why is this strategy important?

From a European perspective, a hospital laboratory is often viewed as a cost center and not a profit center. Therefore, if we add any novel molecular diagnostic (MDx), especially tests that come at premium prices, they will be viewed initially as incremental costs into the system. However, you have to factor in extended length of stay or extra time in intensive care while taking broad-spectrum antibiotics.

From all of the data we have seen in Europe there is every reason to believe that modern MDx can contribute in a cost-effective way towards improving antibiotic stewardship and optimizing health economic outcomes for individual hospitals, while simultaneously delivering medical benefit to patients. One of our distribution partners ran a study in Europe showing that for the implant joint infection cartridge in prosthetic joint infections was able to achieve net savings, after the additional cost of the test, of more than €2,000 per patient.

Will you reexamine the economics case in the United States?

U.S. hospitals are aware of the publications, but we will be doing some of the same types of projects in leading U.S. health systems as well to make sure we generate U.S. data. But frankly, a day in a U.S. hospital or intensive care costs twice of that in Europe. I would anticipate the net health economic benefit would be even greater in the United States.

Why do other diagnostics companies not approach the value question with the same comprehensiveness?

These studies are not easy to do. These studies are complex, and take time and a lot of resources. Historically, diagnostics have been viewed as "cost plus" from a pricing and reimbursement perspective, while therapeutics are very often value- priced. By and large diagnostics are supposed to be cheap. With for example a sub-$100 screening test it is extremely hard to run these multiyear, multicenter million dollar clinical outcomes studies, that would be standard in the therapeutics world. It is not for lack of wanting to do it. The question is from a commercial standpoint can you justify the expense? I think ultimately, there is no avoiding it and we will see more and more of this type of data required.

How do you see MDx for infectious disease testing in hospitals evolving?

If you look at where we are today with infectious disease diagnostics in hospitals in the United States and in Western Europe, the gold standard, which is not so golden, is microbiology culture. We have been doing this for 130 years and it is still the de facto clinical standard of care. We are only beginning to see the advent of molecular tests in infectious disease. In many ways the MDx arena of infectious disease, is where oncology pathology was 15 years ago. Fast forward to today, every pathologist is still looking in a microscope, but they are all doing companion molecular diagnostic testing, too. We are going to see the same thing, hopefully in five years.

Whether BioMérieux, Luminex, GenMark, Accelerate, ourselves, we are all singing the same song—bringing infectious disease microbiology labs into the 21st century by adding molecular diagnostic weapons to the arsenal to combat the threat. Unlike climate change, there seem to be very few, if any, deniers that we have a massive antibiotic stewardship problem if we continue on the path we are on. There is no doubt we will run out of therapeutic options, whether that is in 10 years or 50 years. It will happen and it is broadly acknowledged.

We are not trying to replace culture. There is every reason to believe culture will still be around in the next decade because there are some things you can only do with microbiology culture, but the first line of defense will be much broader, rapid molecular diagnostic assays that give clinicians the answers they need to drive therapeutic decision making in 80 to 90 percent of cases.

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