Luminex Test Technology Entering Clinical Usage

Growing number of labs now generating patient test results from LabMAP™ system

CEO SUMMARY: Multi-analyte diagnostic testing is moving closer to widespread clinical usage. During the past 12 months, several of the nation’s largest laboratory companies have begun to use Luminex Corporation’s LabMAP™ system to generate patient test results. At the same time, the first diagnostic test kits based on LabMAP technology have been submitted to the FDA for review.

EARLY-ADOPTER clinical laboratories are rolling out the first versions of multiplex test assays using Luminex Corporation’s LabMAP™ system.

“Large clinical laboratories are now generating patient results on a regular basis with our diagnostic test system,” stated Randel S. Marfin, Vice President of Business Development at Luminex, based in Austin, Texas. “This is an important milestone for our technology, because it demonstrates that the LabMAP system is effective in clinical settings.”

Growing Sales Of LabMAP

Laboratory executives and pathologists should keep a close watch on Luminex Corporation and its multi-analyte profiling (MAP) technology. As of March 31, 2001, Luminex had sold more than 500 LabMAP systems to customers in the biomedical research, clinical diagnostics and pharmaceutical markets.

More telling, of the 27 strategic partnerships Luminex has developed, 17 are with companies primarily involved in clinical diagnostics. This is evidence that diagnostic vendors consider Luminex’s technology to be credible and want to incorporate LabMap into the diagnostic products they offer their clinical lab customers.

The most recent strategic partnership announced by Luminex involves ARUP Laboratories of Salt Lake City. “ARUP is developing a variety of immunoassay and molecular diagnostic tests that will run on the LabMAP system,” said Marfin. “These assays incorporate the multi-analyte capabilities of the LabMAP system.”

Luminex has similar strategic partnerships with Specialty Laboratories, Inc. and Dynacare’s esoteric division, Dynagene. The company has also sold LabMAP systems to most of the largest lab companies in the United States, including Laboratory Corporation of America.

Other strategic partners are developing diagnostic kits which use the LabMAP system. “Zeus Scientific has submitted an application for diagnostic test kits to the FDA,” noted Marfin. “One Lambda, Inc. and Lifecodes, Corporation have both released human leukocyte antigen (HLA) tissue typing kits for clinical use.”

Revolutionary Technology

THE DARK REPORT was the first in the lab industry to call attention to Luminex and its revolutionary bioassay technology. (See TDR, December 21, 1998.) Because of the relatively modest cost of the complete LabMAP instrument suite, called the Luminex 100 Integrated System (Luminex 100 IS, with a retail price of around $45,000), THE DARK REPORT believes a large number of clinical laboratories will be able to acquire this technology and benefit from it.

The transformational aspects of LabMAP derive from these facts:

  1. The total cost, including a royalty fee to Luminex, is lower for each analyte than conventional diagnostic testing methods;
  2. The current technology can support up to 100 assays per sample and Luminex is developing the capability to do 1,000 assays per sample;
  3. Each sample (with 100 assays) can be tested in just a few seconds;
  4. The sample size can be as small as 50 microliters, or about the size of a capillary tube draw; and,
  5. The LabMap instrument is compact and requires just a few square feet of counter space.

These five attributes illustrate why Luminex’s technology is considered to be a paradigm-shifting breakthrough in diagnostic testing and other bioassay applications in pharmaceutical, bioagricultural, and biomedical research.

Now that clinical laboratories are beginning to use LabMAP to generate patient test results on a daily basis, it is important for lab executives and pathologists to understand the market dynamics currently pushing LabMAP forward.

For diagnostic applications, Luminex has followed a two-pronged business strategy. It actively encouraged two types of customers to acquire LabMAP systems and adopt them for diagnostic purposes.

One class of customers includes the nation’s 10 to 20 largest clinical laboratories. Although Luminex will not disclose names of its lab customers, it is reasonable to assume that several of the large public lab companies own LabMAPs, along with the national reference labs which provide reference and esoteric testing to hospitals and other labs.

These five attributes illustrate why Luminex’s technology is considered to be a paradigm-shifting breakthrough in diagnostic testing…

Beginning in 1999, Luminex began selling LabMAP systems to the biggest laboratories. Luminex represented that these labs could use LabMAP technology in two ways. First, they could use LabMAP to “home brew” existing assays. Typically, “home brew” assays are performed because cost-effective kits are not available or the assay is proprietary to the clinical laboratory. Because only a modest effort and expense is required to set up a home brew assay, labs could quickly benefit from this business strategy.

Develop New Assays

Second, labs with the Luminex 100 IS could develop new assays for proprietary use and commercial sale. This is a longer-term business strategy that has huge profit potential.

For a high-volume laboratory, the “home brew” approach offers immediate and substantial benefits. Although LabMAP is designed to be a multi-analyte testing system, it can also be economically used to perform single assays from single specimens. That’s because it requires only minute amounts of both reagent and microspheres, resulting in a lower cost per test.

The economics are compelling. If a lab does 10,000 tests per year, with a kit cost of $20, and can do the same test on the LabMAP system on a “home brew” methodology at, say $5 per test (assuming marginal costs and the Luminex royalty), the lab would realize savings of $150,000 per year.

Luminex believes labs that follow this strategy would gain competitive advantage. These same labs, if they develop new diagnostic tests designed to run on the LabMAP system, could then market their proprietary tests, creating new revenue streams.

Different Business Strategy

With diagnostic vendors, Luminex has a different business strategy. It wants to license LabMAP as an open technology platform, leaving vendors free to create proprietary tests which run on that instrument.

“In November 2000, we submitted a device master file with information about the Luminex 100 IS (Integrated System) to the FDA,” stated Marfin. “Our strategic partners can reference the device master file in their premarket submissions of diagnostic kits. This permits the FDA to consider the Luminex 100 IS instrument as a component of the diagnostic kit.”

Zeus Scientific is using this process with the diagnostic test kits it has submitted to the FDA for review. It is the same process which ARUP, Dynagene, and Specialty Labs will use as they prepare to bring proprietary tests to market.

Bio-Rad Laboratories, Inc. was one of the first diagnostic companies to form a strategic alliance with Luminex. Bio-Rad, after learning more about the LabMAP technology, recently expanded its strategic partnership with Luminex to include drug discovery applications.

Bio-Rad’s New Product

Bio-Rad has announced a product built upon LabMAP technology. It is called the “Bio-Plex™ Protein Array System” and is designed to enable drug researchers to extract more data from smaller samples.

THE DARK REPORT believes that Bio-Rad is preparing a version of this product for diagnostic applications. The company is tight-lipped about its diagnostic plans. But if it developed a way to use the Bio-Plex system to do many existing diagnostic tests using much smaller specimen samples, that would certainly give it competitive advantage.

Taken collectively, during the past 24 months, Luminex has chalked up some impressive accomplishments. It has strategic partnerships with 27 companies, including 17 diagnostic firms. It has placed 500 LabMAP systems in a variety of labs and other companies. Its vendor-partners have diagnostic test kits now either undergoing FDA review or available for sale.

Compelling Economics

This rapid progress is a signal to early adopter labs. A new era of inexpensive, accurate, multiplex testing is almost here. Early-adopter labs are now generating patient tests results with the LabMAP system. As they accumulate knowledge and experience, it is only logical that these labs will find new ways to use LabMAP technology to improve the quality of clinical lab testing.

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