EUROIMMUN has been a presence in the European market for years, but it has just recently established itself in the United States. We spoke to Silvana Costa, EUROIMMUN’s managing director of finance, sales, and marketing, and Kathryn Kohl, managing director of operations, scientific and regulatory, about the company’s plans for dominance in the US market, the challenges and triumphs it has encountered in the past, and some of the new products we can expect to be introduced.

CLP: EUROIMMUN is fairly new to the US market. What is your plan for introducing your products to the US clinical lab industry?

EUROIMMUN: Although new to the US market, EUROIMMUN has been a world leader in the autoimmune and infectious-disease market for many years. Established as EUROIMMUN AG in 1987, the company’s history and presence in the marketplace extends even further back. The company is known for its technical expertise and product innovation, which have been instrumental in the company’s success worldwide.

We have actually been in the US for close to 2 years establishing our infrastructure, and putting into place our business and marketing plans. Our Regulatory Department has been extremely busy handling clinical trials and submissions to the FDA for product clearances. To date, we have more than 20 product groups that are for in vitro diagnostic use with close to 40 in process, as well as an aggressive program for the remainder of 2006.

We have established a network of sales representatives, a technical support department, as well as in-house marketing. The company’s customer- and product-handling team has been cross-trained, and procedures have been put into place. Our advertising and educational mailing programs are now in full force.

Last year, we unveiled our company at the Association of Medical Laboratory Immunologists (AMLI) meeting to a targeted autoimmune group, which was a huge success for us. This year, we recently attended the Virology Symposium and will be participating in the AMLI Meeting in late August. These meetings serve as excellent conduits to introduce our products and technologies to the opinion leaders and end users.

Our products are now in a number of the major, prestigious laboratories, both large and small. This also is instrumental to our ongoing growth due to the amazing number of referrals we have received.

CLP: How does the US market differ from the international market? How does this affect your marketing efforts?

EUROIMMUN: Every country’s market has inherent differences and nuances. Euroimmun is acutely aware of this and is very responsive to its subsidiaries’ input and guidelines. The management group at EUROIMMUN US has extensive experience in this marketplace, which is utilized quite successfully in making any necessary “product specifications” and adaptations to US needs, wants, and requirements. Of course, in the US the FDA and CDC are important considerations; and we, therefore, work with our product-development team to tailor our products to these guidelines.

The US market is made up of a number of large customers with unique requirements of single lots, stocking issues, bulk packaging, pricing, and instrumentation needs that we must address. The flexibility here and in Germany allows us to effectively respond. In addition, the US also has a vast number of small- to medium-sized laboratories, as well as specialized testing centers. We are cognizant of this group’s needs and can offer a wide test-kit menu, multiple methodologies, and often difficult-to-find products to successfully market to this niche segment.

CLP: What changes/trends have you noticed in the clinical diagnostics market, and how will EUROIMMUN address these changes?

EUROIMMUN: Over the years, the amount of validation and justification required by a laboratory’s governing bodies and regulatory groups has increased dramatically when making changes. The impetus for change, therefore, must be extraordinary—time saving, cost saving, technical advantages, and so forth. The EUROIMMUN product line is uniquely able to provide such innovation and opportunity.

Our IFA product is truly revolutionary in the industry. Our own Biochip™ Mosaic Technology allows from one to as many as 12. These substrates are optimally fixed and then brought together into a single well, producing a slide that is technologically superior to anything available in the market. Our ANCA assay, for example, allows the laboratory to choose from one to four substrates in each well—ethanol-fixed granulocytes, formalin-fixed granulocytes, with control Biochip™ HEp2 cells and primate liver. In infectious-disease testing, we can offer a respiratory panel with up to 20 preparations on one slide. The Biochip™ Mosaic allows IFA Multiplexing of patient profiles and rapid turnaround time, as well as cost efficiency. The TITERPLANE™, our innovative method of running IFA tests, results in standardization, semiautomation for greater efficiency, and time savings. A laboratory can literally run IFA slides faster than if using an automated slide processor.

The EUROIMMUN EIA line offers screens, profiles, and single-antigen assays. We have CSF- and avidity-testing assays in our infectious-disease product groups. Instrumentation is also available as well as product validations on other instruments, and in some cases adaptation to our vial size.

Our Western blots and Immunoblots utilize native and recombinant antigens. Often, both are included on a single strip to provide the most comprehensive test possible. We have automated reading systems for small and large users as well as a computer program: EUROLineScan to archive the results.

CLP: What new products will soon be released by the company?

EUROIMMUN: There are a number of products that we are truly excited about that are in the process of release in the US. Our Lyme VlsE, which virtually eliminates false negatives as the IgM phase falls and the IgG phase has not actually reached normal-detection range, is set to launch just in time for Lyme season. We feel this will be embraced by the market as a huge benefit to patient care and management, and overall cost containment.

The EUROIMMUN HSV 1 and 2 test assays, pending FDA release, have been shown in recent studies to differentiate between the two types of infections. In our beta sites, we have found this to be of tremendous importance to laboratories. HSV 1 and 2 IgM are also available as an RUO at this time.

On the instrumentation forefront, we will be introducing an ELISA-processing system—EUROIMMUN Analyzer I—which is able to handle up to seven plates and allows for ongoing addition of tests and samples. Our unique time-management software allows for unmatched versatility.

A new blue-light LED fluorescent microscope has just now been launched. This saves the laboratory money and is more efficient, safer, and user-friendly when compared with mercury illumination.

CLP: Where do you see EUROIMMUN in the next 5 years?

EUROIMMUN: With the success we have enjoyed during the short period we have actually actively promoted our products in the US market, we can confidently project EUROIMMUN US will become one of the market leaders in autoimmune and in infectious-disease testing within the next 5 years.

Our company will evolve with the changes in the market and respond to the needs of the customers. The customer service and technical support philosophy at EUROIMMUN US will help us maintain and grow with our customers.

In addition to our core products, we have a broad number of niche products, including neurological and allergy tests, that will assist in our market penetration and brand recognition.

CLP: How does EUROIMMUN keep up its philosophy of continual growth, and how does this impact its business?

EUROIMMUN: Continual growth is fueled by a company’s responsiveness to the changes in the market as well as ongoing product improvement and new-product introduction. EUROIMMUN has an extensive product line—possibly the widest breadth and depth in this industry for our products. Innovation and improvements, resulting in a better product, and cost efficiency, are a way of life at EUROIMMUN. This philosophy, although challenging, empowers the company to effectively increase market share and penetration.

CLP: Company literature states that one of EUROIMMUN’s main strengths is its technical expertise. How does this affect its position within the clinical laboratory market?

EUROIMMUN: EUROIMMUN has assembled a tremendous network comprising scientific, technological, engineering, and logistics at our headquarters and worldwide between the large, highly trained, and specialized workforce, as well as affiliations and joint ventures. This group is poised and able to respond quickly to questions, suggestions, and customization to satisfy the ever-growing worldwide customer base.

The importance of technical expertise when supporting a diagnostic product line cannot be overemphasized. EUROIMMUN US sales and support groups are experienced seasoned product specialists well-versed in the technical and business issues facing our customers. We embrace a team approach to best support our customers. With our headquarters’ resources, EUROIMMUN US has laboratory training facilities as well as workshop and training capabilities utilized on-site at customers’ facilities or meeting venues.

We feel that the added financial expense in time, manpower, and dedicated facilities is a worthwhile investment, since it has the ability to set us apart from the competition, affording us a “value-added component.” EUROIMMUN US works with the laboratory to identify the best product combination in keeping with the laboratory’s own philosophy and goals. It then supports the product and the laboratory logistically, but also as a technical adjunct resource.

Michelle Said is associate editor of Clinical Lab Products.