What are the major categories of solutions that bioMérieux provides for its customers? Now in our fifty-first year of operation, bioMérieux is a pure player in in vitro diagnostics, focusing on the diagnosis of infectious diseases. In particular, we are a leader in microbiology. We have pioneered many technologies that are used in clinical and industrial microbiology labs today.
Looking forward, a near-term focus for the company is to evolve the syndromic molecular testing market for infectious disease diagnostics. Our molecular diagnostics company, BioFire Diagnostics, specializes in a PCR-based automated diagnostic platform called FilmArray. In addition to optimizing workflow, FilmArray testing panels are based on this syndromic approach. This process involves defining a set of symptoms typical for common ailments, for example, respiratory infections or infectious diarrhea, and very quickly determining the infection that is to blame by using this fully integrated and very user-friendly multiplexing PCR (polymerase chain reaction) system. The system can simultaneously identify the most common bacteria, viruses, yeast, or parasites typically associated with the symptom-defined syndrome(s) and provide sample-to answer results in as little as one hour. We believe the syndromic approach will improve patient care thanks to the high medical value provided, reduce healthcare costs, and make our lab customers’ lives much easier. Our overarching goal is to help improve public health by making diagnostic tests for infectious disease both faster and more accurate.
How is the microbiology lab different today from what it was ten years ago? How might it be different ten years from now? How has bioMérieux accommodated the former, and how is it preparing for the latter? Automation revolutionized hospital clinical chemistry and hematology labs many years ago, but the degree of sophistication required to automate the microbiology lab has proven to be a much greater challenge. The microbiology lab is very complex, with significant variations in sample types, culturing requirements, and the final identification of an organism from among hundreds of potential microbes. Automating the microbiology lab has been one of bioMérieux’s goals over the last several decades, and we’ve made dramatic strides—most recently, via our strategic alliance with COPAN to automate clinical microbiology laboratories and enhance operation efficiency.
A trend we are also seeing is the decentralization of testing. As hospitals merge into larger systems, these systems have turned to core microbiology labs to manage the ever-growing demand for microbiology testing services. Automation plays a key role in this, but automated technology is only half the process. High performance is achieved through a combination of many processes working in collaboration. We are applying a holistic approach uniting automated technology, process, and personnel to maximize efficiency and help labs deliver sustainable long-term value.
How has the company led in the area of rapid testing? Our mass spectrometry platform, the VITEK MS, which identifies 193 bacteria and yeast, is having a truly dramatic impact by condensing the time it takes for labs to generate positive identification. The BioFire FilmArray platform—with cleared panels for blood culture identification, respiratory infections, and gastrointestinal infections—can collectively test for more than 100 viruses, bacteria, yeast, and parasites as well as antimicrobial resistance genes, all in about one hour.
It was major industry news when bioMérieux acquired BioFire Diagnostics last year. How is the marriage going? How has bioMérieux integrated molecular diagnostics into its product offerings? Integration is going very well and exceeding our expectations. The U.S. market was ready for FilmArray and eager for new panels. Organic growth stood at more than 60 percent in 2014; sales have exceeded expectations. We are working on the global rollout of FilmArray in Europe, Asia, Latin America, and the Middle East.
Salt Lake City, Utah, where BioFire is located, has become our North American molecular diagnostics center for expertise. bioMérieux’s European molecular hub is in Grenoble, France, and the two centers are joining forces to develop BioFire panels to meet demands.
This past February the FDA approved the FilmArray 2.0 system. What has been and will be the significance of this for bioMérieux’s customers? FilmArray 2.0 offers the same strengths of rapidity, ease of use, integration, and accuracy that characterize the current FilmArray. Each system accommodates one to eight FilmArray units operated by a single computer. The system is also capable of connecting to laboratory information systems. By compounding the diagnostic power of FilmArray with up to eight separate units, customers now can have random access processing of up to 175 samples in a day within a small footprint.
bioMérieux has been a leader in the battle against sepsis, both in terms of science and technology and raising public awareness. How will diagnostics reduce the incidence of sepsis in North American hospitals, or worldwide? Sepsis is a race against the clock, so we are focused on reducing the time it takes to positively identify a sepsis patient. We are particularly focused on demonstrating the benefits of our combined solutions for sepsis. By adding the FilmArray BCID panel to the VIDAS B·R·A·H·M·S PCT, procalcitonin biomarker for sepsis, and BacT/ALERT 3D, we believe bioMérieux now offers the most impactful suite of products for detecting, diagnosing, and managing septic patients.
You have executive experience in both Europe and the United States, and you hold both U.S. and European law degrees. How has this background prepared you for your current position? Different cultures are sometimes challenging, but this can also prove to be an immeasurable source of strength. We see cultural differences as competitive advantages, as we learn from our colleagues in different parts of the world. bioMérieux is a company with great people who genuinely care about advancing public health, and it is a privilege to be able to be part of this. bioMérieux is a public family company with values in the Pasteurian tradition, but also a true entrepreneurial the U.S.