Luminex and PerkinElmer Ink Licensing Agreement

Company known for high-volume systems will explore applications in clinical diagnostics

CEO SUMMARY: PerkinElmer’s interest in the multiplex capabilities of Luminex’s xMap technology led to this new licensing agreement. PerkinElmer’s instrument systems played a major role in accelerating the work of the Human Genome Project. Now, besides bioresearch applications, PerkinElmer wants to look for opportunities to develop high-volume, multi-analyte assays for in vitro diagnostics.

IN RECENT MONTHS, Austin, Texas-based Luminex Corporation has licensed its xMap® multiplex testing technology to some interesting companies.

Probably the most noteworthy licensing pact—and the one with potential to make a big splash in clinical diagnostics—is the deal announced last week between PerkinElmer, Inc. and Luminex. PerkinElmer has licensed the right to use xMap technology to develop high-volume screening applications in life science research and in vitro diagnostics.

Pharma Biomarkers

In the research sector, PerkinElmer wants to develop uses for xMap technology in pharmaceutical biomarkers and ADME/Tox. The term “ADME/Tox” describes a fast-growing research discipline which specifically looks at how drugs are adsorbed, distributed, metabolized and eliminated from the body, along with any harmful or toxic properties of either the drug or its metabolites.

In the field of in vitro diagnostics, PerkinElmer intends to explore how xMap technology can be adopted for maternal, neonatal and prenatal health. PerkinElmer says it wants to standardize its multiplex assay development on the Luminex xMAP platform.

Laboratory administrators and pathologists may recall that PerkinElmer anchored the private sector effort that raced with government-funded researchers to complete the map of the human genome. Both PerkinElmer’s money and its DNA sequencing instruments sup- ported C. Craig Venter, Ph.D.’s company, Institute for Genomic Research, in its effort to map the human genome. That was in May, 1998. THE DARK REPORT was first to alert the clinical laboratory industry to this partnership and predicted that, by using PerkinElmer’s newest generation of high-volume genetic sequencers, this group was likely to beat its own estimates. (See TDR, June 15, 1998.)

PerkinElmer and Venter estimated it would take them less than $300 million and no more than four years to accomplish the task. By contrast, the government-funded Human Genome Project, launched in 1990, was budgeted to spend $3 billion and not complete its work until 2005.

It was on April 14, 2003, that a press conference was held to recognize that the human genome had been sequenced and this phase of the Human Genome Project was completed ahead of schedule. One major factor in this acceleration of the timetable was the use, by government-funded researchers, of PerkinElmer’s fastest genetic sequencing instruments.

Diagnostic Applications

This background on PerkinElmer is relevant because of the disclosure that the company intends to develop high-volume, multiplex instruments for diagnostic testing applications. PerkinElmer is a credible competitor in bioresearch. Thus, its interest in Luminex’s multiplex diagnostic technology and its stated goal of developing in vitro diagnostic tests signals the possibility that the company might one day become a significant sup- plier of clinical diagnostic technology to the lab industry.

Another Luminex licensing agreement involved Charles River Laboratories International, Inc. of Wilmington, Massachusetts. It was announced on January 5. The Charles River Research Animal Diagnostic Services division will use xMap technology to create a “multiplexed fluorometric immunoassay (MFIA) that will be the platform for screening laboratory animal serum samples for infectious disease.

This connection is interesting because Charles River is a supplier of animals for medical testing. It also produces eggs for vaccine production. The company’s interest in a multiplex assay for infectious disease testing indicates pressures in the research market for more sensitive assays that cost less money.

New Diagnostic Tests

Many IVD companies have licensed Luminex’s xMap technology and are introducing diagnostic tests based on this technology into the clinical market. Just last November, Tm Bioscience Corp. announced the release of an upper viral respiratory panel that detects all of the major human respiratory viruses. This includes SARS Corona and the Avian Flu (H5N1).

Tm Biosciences has mated its Tag- It™ chemistry with xMap technology to create this new diagnostic panel. Tm Biosciences is probably best-known for its Tag-It™ Cystic Fibrosis (CF) Assay. This test was cleared by the FDA in Spring, 2005 and Tm Biosciences holds supply agreements for this test with
Laboratory Corporation of America and Genzyme Corporation.

The business strategy at Luminex is to offer non-competitive licenses for xMap. As its licensees bring products to market, Luminex earns revenues from the sale of the instrument and consumables, and royalty payments based on test volume. It is the Microsoft–Intel open platform strategy.

Steady Revenue Growth

For 2005, Luminex will generate an estimated $36 million in revenues. It has licensed its technology to major pharmaceutical companies, bioresearch firms, and IVD manufacturers.

As noted earlier, PerkinElmer’s interest in acquiring and developing Luminex’s xMap technology may have long-term consequences for clinical diagnostics. If the company succeeds in marrying its high-volume processing technology with xMap’s multi-anolyte capability, the result may be a breakthrough diagnostic system.

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