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Affymetrix Deal May Symbolize BioMrieux s Initial Steps as Molecular Diagnostics Provider

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Analysis

The news that French biotechnology firm BioMérieux may soon commercialize a microarray-based in vitro diagnostic to detect the contents of animal feed and meat for human consumption may represent the company’s first steps in becoming a molecular diagnostic tool provider for primary-care physicians.

The move might also make BioMérieux and Affymetrix de facto rivals in one area — an ironic turn of events because the two companies have been collaborators since 1998, and that it is Affy’s GeneChip that will enable BioMérieux to launch its meat-content and animal-feed product over the next three months [see related story, above].

In June, a BioMérieux official told SNPtech Reporter that the company plans by the end of the year to develop a chip reader that will be faster and less expensive than the Affymetrix-based platform that has been available as part of a BioMérieux platform to at least two European nations as of this summer. The meat-content and animal-feed chips will likely be read by that scanner.

Ali Laayoun, director of molecular diagnostics at BioMérieux, said the company’s interest in clinical molecular diagnostics represents an “obvious” evolution from traditional immunoassay-based techniques and petri dishes to the era of microarrays and polymerase chain reactions.

“It is the right time for us,” Laayoun told SNPtech Reporter during the IBC molecular diagnostics and personalized medicine meeting in London in June. “We know the future will be in molecular diagnostics.”

This week, in a joint news release with Affy, Christophe Mériéux, vice president and director of medical affairs and research at BioMérieux, stressed: “The collaboration with Affymetrix is highly important in this field and demonstrates our determination to remain a major player within in vitro diagnostics and especially in molecular biology. Access to [the] GeneChip platform will allow us to introduce … diagnostic tests into clinical routine. …"

The animal feed and meat-content product, then, appears to be the first stepping stone to a molecular diagnostic product for clinical use. According to Laayoun, such an array-based platform would initially be used by physicians to determine which strains of a wide array of bacteria and viruses, such as HIV and hepatitis C, have infected patients. He said the company also plans to develop the platform to perform similar genotyping of parasites such as fungi.

As it stands now, the system, which has been available to pilot testers in at least two European countries, is a standard molecular diagnostics platform: A blood sample is drawn and sent to a lab where it is processed. There, the bacterial or viral DNA is extracted, amplified using PCR, and labeled. Finally, after the DNA is hybridized to a GeneChip array and scanned, physicians are sent results that help them determine a therapy.

But Laayoun told SNPtech Reporter that BioMérieux will by the end of next year have a mostly internally developed platform that will be faster and less expensive than the existing system. He said the new platform will comprise a DNA/RNA-extraction tool made by BioMérieux called Boom. The company will also use an in-house labeling fragmentation system called LDC. And while BioMérieux will continue to use PCR and Affy’s fluidics station for target hybridization, the firm will eventually market its own chip reader — which appears to be the product that BioMérieux hinted at in its Oct. 10 news release: The firm said the food and animal feed diagnostic will be “powered by Affymetrix technology, with a new instrument and software platform developed by bioMerieux.”

Laayoun would not say how Boom or LDC work, or how much the entire platform would cost, but said BioMérieux’s new system will likely be one-tenth the cost of Affy’s $120,000 chip analyzer. He also said the entire process, from DNA extraction to chip analysis, would take between five and eight hours.

BioMérieux’s new platform is currently being pilot tested at a handful of labs in Switzerland and Holland. Laayoun declined to disclose the names of the labs.

Asked in June who BioMérieux’s biggest competitor would likely be, Laayoun answered Roche. “The competition in microbiology is strong, but Roche doesn’t have its own [genotyping] tools,” said Laayoun. “That’s where the difference is, and that’s where we have the edge.”

An Affymetrix spokeswoman stressed that the desire by BioMérieux to develop its own chip reader is “not uncommon,” and, besides, BioMérieux will continue to use GeneChips in its molecular diagnostics applications. BioMérieux “obviously feels pretty strongly about this area in terms of using microarrays, because they reaffirmed their committment to us,” said the spokeswoman, Anne Bowdidge, referring to the extension by BioMérieux of a technology-provider relationship with Affy.

Jean-Luc Balzer, director of BioMériéux’s food and animal-feed program, declined to comment for this article.

BioMérieux was founded in 1963 by Alain Mérieux, whose grandfather was a student of Louis Pasteur. The company bills itself as a designer, developer, manufacturer, and marketer of reagents and automated instruments for medical analysis, including pathogen detection.

In 1986, BioMérieux acquired API, a reference in manual identification and susceptibility testing. Two years later it bought US-based Vitek, which allowed BioMérieux to “complete” its automated microbiological diagnostic range and get a “stronger foothold” in the United States. Finally, in 2001, BioMérieux acquired Organon Teknika, the diagnostics division of Dutch chemical and pharmaceutical giant Azko Nobel.

Today, BioMérieux, which is based in Lyon, has offices and manufacturing facilities in Chicago; Durham, NC; Rockland, Md.; Oklahoma City; St. Louis; and Washington, DC. The company, which employs around 7,000 people, also has bases in Florence, Italy; Boxtel, the Netherlands; and Rio de Janeiro.

The company currently sells products for antimicrobial susceptibility testing, blood culture chemistries, hemostasis, and a suite of immunoassays for HIV, allergies, hepatitis A and B, and thyroid tests, among other technologies.

Yet despite BioMérieux’s interest in the IVD marketplace, the move to create a new molecular diagnostics platform will occupy a decidedly modest corner of the company’s R&D budget, and will contribute “a small bit” to BioMérieux’s revenue. BioMérieux earned 799 million euro in 2001 and spent around 12 percent of that on R&D, according to the company’s web site.

“Molecular diagnostics does not represent a big percentage of BioMérieux’s revenue,” Laayoun said in June. “But it will grow.”

— KL

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