As a leading multiplex solution developer, Luminex Corporation’s unique, proprietary xMAP® technology is used globally in the clinical diagnostics, pharmaceutical drug discovery, biomedical research, biodefense, and specialty markets. Currently, Luminex has more than 50 strategic partners worldwide, 32 patents issued, 60 pending patents and 30 FDA-cleared partner products. We spoke with the president and CEO of the company, Patrick J. Balthrop, about Luminex’s xMAP technology and the company’s position in the marketplace.

CLP: Please tell me a little bit about your background and your history at the company.

Balthrop: Prior to joining Luminex, I served as the president of Fisher Healthcare, a Fisher Scientific International company.  Including my years of experience in Abbott’s Diagnostic Division, I have more than 25 years experience in the diagnostics and life science industry, including R&D, manufacturing, sales and marketing, intellectual property and technology management, and international operations.

I came on board as the president and CEO of Luminex 2 years ago and introduced some sweeping changes to address serious business challenges the company was experiencing. Infrastructure and quality changes were made in 2004 and financial planning and resource allocation for 2005 ensured spending would prioritize Luminex R&D investment to accelerate new product flow, including a new content strategy. Strategic sales and marketing programs were initiated to drive market adoption and favorable product mix. The results of the changes have been most favorable, with tremendous financial progress for the company in 2005 which has continued into 2006.

CLP: Tell me about Luminex’s history and how the company has come to where it is in the market today?

Balthrop: Luminex was founded in 1995 and has been public for 6 years. Luminex introduced its xMAP technology-based multiplexing platform in 1999. After a rough early few years, I was hired in 2004 to re-engineer the company. In late 2004, we implemented a new business growth strategy and refocused the company on the customer and end-user. Luminex’s growth and profitability has accelerated. In that short time frame, Luminex’s xMAP technology has moved to the leading edge of innovative technology across multiple markets and industries.

In 2005, Luminex launched our first new product in several years, the new Luminex 200 instrument system. We established a biotech leadership position in cytokines, transplant medicine, and microRNA. Luminex earned the Frost & Sullivan Clinical Diagnostics Technology of the Year award and we were named in the 2005 Deloitte Fast 500 of Fastest Growing Technology Companies in North America. In that year of many new milestones, 2005 was the year Luminex partner Tm Bioscience became the first company to receive FDA clearance for a multiplexed cystic fibrosis (CF) screening assay, built on Luminex’s xMAP technology.

Today, more than 3,500 Luminex systems have been placed in large clinical and public health laboratories, academic institutions, major pharmaceutical companies, bio-defense facilities, and major medical institutions as well as community hospitals.

CLP: What needs does the company satisfy within the clinical laboratory market?

Balthrop: Quality and performance have always been critically important in the clinical laboratory market as are the issues of cost and efficiency. The ability to make informed medical decisions is paramount, as is the ability to do so in a highly reliable, accurate, precise, and costefficient way. This applies to Luminex because what we deliver to the marketplace is a technology that addresses all of these points. Our xMAP technology delivers very high performance and does so in a way that impacts cost in real terms, especially in reduced labor costs. Our core xMAP technology delivers to laboratory professionals microsphere-based multiplexing that, in turn, provides a fast, reliable, and economical way to perform complex bioassays, yielding up to 100 reproducible results from a single sample. Additionally, xMAP technology is unique in its versatility to perform both DNA and proteinbased assays and in its flexibility to easily expand or reduce assay panels as needed to deliver fast, accurate, and cost-effective bioassay results.

CLP: What trends do you see impacting the industry? How is Luminex adapting and responding to these trends?

Balthrop: The promise of the molecular diagnostics market has finally begun to come to fruition. The development of reliable technologies that can deliver reliable nucleic acid based assays, both DNA and RNA, and that are also consistent with traditional good laboratory practice, has been elusive. But technologies such as xMAP technology are meeting these standards. That, combined with the research to establish the clinical utility of multiplexed nucleic acid assays, is creating—finally—a real molecular diagnostics market. The future will likely be panels of between 5 and 100 markers that can be used to aid diagnostics and guide therapeutic decisions. Luminex is uniquely positioned—much more so than two-dimensional arrays, so-called biochips—to take advantage of these trends.

We are responding to these trends by increasing our R&D investment—it went up by 47% in 2005, for example—to develop the platforms that the end user needs in order to perform these assays, and, with the new Luminex Bioscience Group, by working with our strategic partners to ensure that the assay menu available to the end user is consistent with their needs.

CLP: What products does Luminex plan to offer in the near future?

Balthrop: We are currently developing a multiplexed protein assay in the pneumococcal class, and a new life sciences product utilizing microRNA technology licensed through MIT. These will be the first new product introductions of the Luminex Bioscience Group. We anticipate that the new microRNA product will have broad applications. The planned product introduction is the fall of this year. In addition, we have several other new instrument products in development in the Luminex pipeline.

CLP: What challenges or obstacles has Luminex encountered and what has the company done to overcome them?

Balthrop: There was a lot of work to do when I arrived in 2004. Two years ago, like many companies with innovative technology, Luminex was technology-centric with an accompanying lack of focus on the customer and end-user. Since then, we have changed the organization from a technology-centric structure to one whose priorities are the customer, market and industry segments, and needs. This was accomplished by creating a new vision for Luminex. We initiated the CAPP (Customers, Accountability, Profitability, Performance) Program, which revolves around individual and company-wide goals using an objectives management system to drive performance and accountability. We also built on Luminex’s strengths, which include solid and dedicated employees and a sound technology. This has resulted in substantial progress for the company including our renewed commitment to growth through R&D investment, reflected in the 2005 increase in R&D by 47% over 2004. This year, Luminex achieved 1Q 2006 results of revenue growth of 39%, gross profit improvement of 12 percentage points, and the first profitable quarter in the company’s history.

CLP: What would you like CLP readers to learn about Luminex?

Balthrop: Multiplexing, especially focused multiplexing, is the future of the industry. Our xMAP technology is groundbreaking but built on proven principles. This gives laboratorians a high degree of confidence in the results generated. Microspheres have been used for a long time. The flow cytometry principle is well proven, very robust and very well known. The application of innovation and our proprietary xMAP technology, combined with these proven principles, positions Luminex very well to become the technology platform of choice, not just in molecular diagnostic testing, but also in multiplexed protein assays. We will be able to solve problems that so far have gone unsolved.

Michelle Said is associate editor of Clinical Lab Products.