Corporate Profile

Molecular analysis has become a critically important tool for medical research, clinical diagnosis, and other fields where insights into biological interactions and disease processes accelerate and enhance decision making. Luminex Corporation is a private company developing and commercializing a new molecular analysis technology exceptionally suited to satisfy the growing demand for efficient, cost-effective testing. Luminex's technology is unique in its ability to simultaneously perform hundreds of molecular tests simply, quickly and economically on a single patient sample. The Luminex platform couples existing technology with advanced digital signal processing and proprietary identification techniques to perform a full range of molecular tests in real time. The advanced capabilities of this technology provide Luminex with an opportunity to participate significantly in the large and growing markets for comprehensive and cost-efficient molecular information.

Luminex is focused on the research, clinical, and drug discovery markets where the need to analyze multiple molecular interactions simultaneously is well established and expanding rapidly. The company's first generation FlowMetrixä System, capable of performing up to 64 different tests on a single sample, was introduced to the research market in 1997. It is currently in use at major clinical and research laboratories, and at many large pharmaceutical companies. To maximize the value of the technology for its many potential markets, Luminex is developing it as an open system, utilizing both internal development and collaborative partnerships to develop assays and systems. The next Luminex diagnostic platform product, capable of performing up to 500 separate tests simultaneously, is scheduled for introduction in early 1998.

 

Business Opportunity

In 1996, the in-vitro diagnostic market exceeded $5.0 billion with a 12% annual growth rate. The dramatic increase in information related to metabolism and how changes in biological intermediates relate to normal physiology, aging, and disease are already contributing to a demand for more cost-effective methods to capture and use this information in medicine. In addition, as genetic information becomes more integral to medical diagnosis and treatment, the demand for molecular tests is expected to experience tremendous growth.

Luminex is focusing initially on developing its technology for research, healthcare diagnostics and drug discovery markets, using its own resources for initial development and commercialization. It will also seek partnership programs for the development of diagnostic kits integrating its technology with a line of complementary products. The Company intends to expand its business through product alliances and the accompanying sales of jointly marketed hardware, software and consumables. Luminex will be advancing initial core diagnostic assays, but plans to partner with others who lead in the development of clinically relevant assay panels similar to the way software applications are developed for a computer operating system.

Luminex plans to expand its technology to other applications within the healthcare industry and beyond. Potential applications of the Luminex technology platform are summarized below.

Research Gene, protein and antibody profile analysis applied to interpreting changes in specific biological pathways, drug discovery, and clinical research.
Healthcare Genetic profile analysis, infectious disease monitoring, drug testing, and clinical evaluation to support clinical diagnosis.
Pharmaceutical Quality control during drug production; potential new market in defining genetic profiles appropriate for various therapeutic options, particularly in cardiology and cancer.
Agriculture DNA and immunoassay methods to test for food-borne pathogens and analyze plant genomics.
Environment Analyze and characterize water, soil, and air for biohazards and to facilitate effective cleanup.

Luminex Technology

Because of the complexity of molecular and genetic interactions in living systems, the predictive and diagnostic value of molecular testing is greatly enhanced when interdependent parameters can be measured and analyzed simultaneously. In medical and drug discovery research, changes in DNA, RNA, and protein levels are critical to understanding and interpreting complex genetic and biological interactions. The advancement of this understanding is triggering the advent of pharmacogenomics resulting in gene-based therapeutic opportunities.

In diagnostic testing, the ability to simultaneously measure multiple markers of possible disease is increasingly important as more potential indicators are discovered. For example, a cholesterol test alone is inadequate for assessing the risk of heart disease. The FlowMetrix System allows complete heart disease assessment including high-density lipoprotein (so called "good" cholesterol), low-density lipoprotein ("bad" cholesterol), lipoprotein a, as well as other relevant markers. Luminex' technology can make this analysis accessible and practical in today's environment of constrained costs and limited time. Whether in a research or clinical setting, Luminex' technology offers unparalleled flexibility in designing, modifying, and conducting multiple molecular analyses.

Existing Technologies

FlowMetrix

One sample is sub-divided into the number of tests One sample, up to 64 tests (soon to be over 500)
Sample size increases as number of tests increase Constant sample size
DNA, immunoassay or enzymatic DNA, immunoassay and enzymatic
Manual handling for each test Manual handling once for all tests
Automated test selection in complex, expensive, programmable handlers Automated test selection in simple, liquid phase packaging.
Specific lengths of DNA strands Flexible lengths of DNA strands
Radioactivity No Radioactivity

Luminex Technology: Color-Coded Microspheres

Luminex technology combines advances in computing and optics with a new concept in color coding to create a simple, cost-efficient analysis system. Color-coded microspheres identify each unique reaction. Hundreds of microspheres sets can be identified at once in a single sample. Advanced computer and optical technology recognizes each microsphere and provides a precise, quantitative measure simply and in real time.

Because Luminex' technology depends on advancements in computing and optics, improvements in processors and laser diodes will continue to enhance the power of the technology. Today, up to 64 microsphere sets are recognized. The current FlowMetrix System is compatible with the Becton Dickinson FACScanâ and FACSCalibur , the most widely used flow cytometers for cellular analysis. Luminex is currently developing a more powerful, independent system for release in early 1998 that is capable of measuring over 500 molecular reactions simultaneously.

Because the Luminex technology requires fewer steps to assess multiple parameters with a high level of sensitivity and accuracy, it is significantly more cost-effective than current methods of analysis. Substantial savings in labor, time, expensive reagents, and consumables are realized in a wide variety of testing formats. Additionally, the comprehensive nature of the test results can enhance the decision-making ability of researchers and clinicians by allowing for the optimal course of research or treatment, respectively, to be quickly and efficiently determined.

Management

Luminex was incorporated in May 1995 and is privately held. The company has 27 employees and is headquartered in Austin, Texas.

Mark B. Chandler, Ph.D., Chairman and CEO

Dr. Chandler has over 15 years of experience in business leadership within the scientific and biotechnology industries. In 1982, he founded Inland Laboratories, Inc and in 1987, was honored with the KPMG Peat Marwick, High Technology Entrepreneur of the Year Award.

Van S. Chandler, Vice President, Instruments

Mr. Chandler has a broad range of management experience in hardware and software engineering and algorithm development. He was responsible for the software development of Tandy Corporation’s first personal computer in the late 1970s and designed the first commercially successful word processor for a PC. As Founder, President, and CEO of Concept Communications from 1985 to 1990, Mr. Chandler developed the first commercial desktop video-conferencing system for personal computers.

R. Jerrold Fulton, Ph.D., Vice President, Research

Dr. Fulton served as Director of the Immunochemicals Division of Inland Laboratories and as Assistant Professor at the University of Texas Southwestern Medical School.

Ralph L. McDade, Ph.D., Vice President, Development

Dr. McDade served as Director of Research and Development at Inland Laboratories and as Assistant Professor at Louisiana State University Medical Center.

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