Expert Opinion

Be the first to know with Philippe SansbioMrieux North Americas President & CEOCelia Stevens: In your view, what are the key trends that will drive the future of the clinical diagnostics industry?Philippe Sans: Diagnostic laboratories are under constant pressure to reduce costs and improve the turnaround time of test results while, many times, working with inadequate staffing. The challenge is for companies like bioMrieux to come up with solutions that enable laboratories to meet these demands. It is up to us to come up with economic solutions that reduce costs and improve patient outcomes for the healthcare system. In this day and age, usable, timely information is key to the success of any operation, and laboratory diagnostics should be no different. I believe the laboratory has a wealth of information which the hospital may be underutilizing. This opens up a whole new area where the lab can demonstrate to the hospital how much more value its information can be to the overall patient care and economic picture. Stevens: Nucleic acid diagnostics is one of your companys four major product lines. What impact will genomics and proteomics have on your future product offerings?Sans: We are seeing a definite trend in terms of greater acceptance of analyte-specific reagents for esoterics in university hospitals, due to the need for rapid, sensitive results that can affect patient care decisions.Our future product offerings depend on the adoption of molecular testing, and that will depend upon the cost/benefit ratios and ease-of-use features (real time, multiplex capability and sample preparation). If molecular testing allows laboratories to provide information that enables physicians to make management decisions during their shifts, the outlook can be very good. bioMrieux has solutions for customers who want easy-to-use molecular systems with quick turnarounds. One example would be our NucliSens EasyQ system, which provides real-time detection using nucleic acid sequence-based amplification (NASBA) technology with molecular beacons for the identification or detection of infectious diseases and viral agents. Another key example is the VIDAS probe amplification system, which will be launched this year. This dual platform system will offer fully automated amplification and detection by using TMA or Transcription Mediated Amplification. This will allow VIDAS users to utilize probe technology simply by adding an Amp station. This system is very easy to use; our first test launched will be chlamydia, with a planned menu expansion to include tuberculosis and gonorrhea, just to name a few. The tests will be both quantitative and qualitative. Stevens: The history of your company is marked by significant acquisitions, the most recent being your acquisition of Organon Teknikas diagnostics division in July 2001. How has the integration proceeded? Sans: We closed the transaction on June 29, 2001, and completed most of the integration by Dec. 31, 2001. We moved our U.S. headquarters from St. Louis, MO, to Organon Teknikas location in Durham, NC. The combined management team equally includes executives from both companies. The integration was made easier because both companies have European parent companies and similar corporate cultures. We are proud of our new customer service organization. We have made a significant investment to improve our customer care. We merged two excellent customer service organizations, and as a result, we are building a world-class team.All in all, this past year we grew U.S. revenue by double digits to about $250 million, exceeding our forecasts. By all measures, the integration has been a success.Stevens: The fit between the microbiology line of Organon Teknika and bioMrieux made a lot of sense. What is the future of the coagulation line?Sans: The future for the coagulation product line has never been better. We now have key contracts with Fisher, Allegiance and Premier. Coupled with our patented Waveform Analysis technology that provides more information from routine PT and APTT assays than just clot time alone, we have every reason to be very optimistic about our coagulation business. This patented technology is particularly exciting, as the first clinical application is identification of an abnormal APTT waveform pattern that has been shown to be an early indicator of sepsis. Once again, a perfect fit for the bioMrieux focus on improving the diagnosis and management of infectious diseases.Stevens: What impact will the threat of bioterrorism have on clinical microbiology products of the future?Sans: That is a very good question. In the long term, I believe you will see a movement towards field-based testing instruments. In other words, I mean hand-held, point-of-care testing that is easy to use and gives immediate results, but has a very narrow purpose. In the short term, however, many of the tests will require patient specimens to be sent to a laboratory for analysis. I believe you will see additional appreciation for current systems, as well as expanded menus and added flexibility. During the anthrax scare, our automated BacT/ALERT 3D played a major role in the initial detection of the anthrax cases, as the primary diagnostic test was blood culture. Stevens: How has the shortage of clinical laboratory personnel affected your business strategy?Sans: Because it is difficult for laboratories to attract and retain qualified people, we have developed easy to use instrumentation, such as our BacT/ALERT 3D and VITEK 2 microbiology systems. These fully automated systems free up highly trained laboratory personnel to do other tasks. For example, the VITEK 2 has software that assists technologists, regardless of experience or expertise, in the detection of antibiotic resistance. In addition, bioMrieux will research opportunities to develop service packages that will assist laboratories that use our products. The service packages will be designed to assist them in dealing with the shortage of laboratory personnel.Stevens: What is your strategy for Web-based activity?Sans: Our slogan is Be the First to Know. What that means to our customers is that we want to be a company that provides the latest information to help them. Therefore, on our website,www.biomerieux-usa.com, we provide information on our products and our company, as well as topics of interest via scientific posters, presentations and package inserts. One of the most popular features on our website are our knowledge forums and symposiums. Technology has made information easier to obtain, and bioMrieux has made a commitment to keeping the professionals we serve informed about issues affecting our industry. To that end, we are pleased to make available interactive presentations, free of charge. The presentations cover various popular topics regarding laboratory issues. People can either order the CD of the presentation or view the presentation on our website. Our goal is to continually update our website with important, useful information that will enhance our relationships with our customers and potential customers. Over time, we want our website to become more interactive, providing opportunities for Web-based learning, user group activities, and dissemination of information.Stevens: How does bioMrieux view the physicians office laboratory segment, which is among the fastest-growing laboratory segments? How has the emergence of these labs shaped your business strategies?Sans: We have set our company up to directly address this market by offering easy-to-use immunoassay testing with our VIDAS system. This will reduce physicians office laboratories costs by helping them avoid sending out for testing and provide quicker answers. This will allow physicians to provide better patient care and generate revenue. Additionally, we have put into place organizational changes to provide resources and a strategic focus on the unique needs of the physicians office labs of the market. Stevens: Do you believe that reimbursements will keep pace with costs as new diagnostic technology is introduced?Sans: As a diagnostics manufacturer, we need to perform economic studies to document the value of new diagnostic tools, thereby justifying higher reimbursement. Stevens: What will be other significant challenges facing the clinical laboratory in the next five years? How will bioMrieux help labs meet those challenges?Sans: At bioMrieux, we would like to enhance the information that laboratories generate to diagnose patients in other words, to provide actionable results and value, not just data. Data that can enhance economic and patient outcomes. We can provide the laboratories with the tools to show the physicians how the information they provide can add more value to the decision making process.There will be challenges to meet Occupational Safety and Health Act and JCAHO guidelines for employee and patient safety. bioMrieux will launch plastic bottles for the BacT/ALERT blood culture system in 2003, which enhance laboratory employee safety. We will also introduce a new method of technology to assist in detecting hospital-acquired infections (aka nosocomial infections). We have an agreement with MedMined [Birmingham, AL] and their data mining service, to launch a product that will quickly analyze patient data to detect these outbreaks. This, coupled with our TheraTrac pharmacy intervention system, which provides adverse drug monitoring for patient identification and intervention activities, should help increase patient safety.