French microbiology company BioMérieux has decided to take a stab at in vitro diagnostics, and soon plans to market a diagnostics platform to primary care physicians worldwide, a company official told SNPtech Reporter.
Ali Laayoun, director of molecular diagnostics R&D for BioMérieux, said the platform will be an internally developed version of a system that is currently available to researchers in two European countries.
The move will deposit BioMérieux into a market dominated by a handful of large pharmaceutical companies and well-known tool providers. It will also divorce the 40-year-old company from the two firms whose technologies are currently part of its existing system: Roche Diagnostics and Affymetrix. BioMérieux forged an agreement with Affymetrix in 1998 to develop applications of the company’s GeneChip technology for HIV genotyping and microbial contamination tests on a BioMérieux instrument platform, and BioMerieux and Roche Diagnostics have licensed one another’s diagnostic technology. But the decision to enter the space will make these two erstwhile technology providers de facto competitors.
However, Laayoun said the company’s new interest in clinical molecular diagnostics does not represent a departure for BioMérieux, but rather 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 last week.
“We know the future will be in molecular diagnostics.”
Vive la Difference
According to Laayoun, BioMérieux’s platform will 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.
Currently, the system is a standard — if expensive — genotyping 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 an Affymetrix GeneChip-brand microarray and scanned, physicians are sent results that help them determine a therapy.
But Laayoun said 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. (Interestingly, BioMérieux subsidiary OrganonTeknika licensed this technology to Roche in 1999.) The company will also use an in-house labeling fragmentation system called LDC. And while BioMérieux will continue to use Roche’s PCR and Affy’s fluidics station for target hybridization, the firm will eventually market its own chip reader.
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 significantly less expensive than existing platforms because BioMérieux’s chip reader will be 10 times less than Affy’s $120,000 chip analyzer. He also said the entire process, from DNA extraction to chip analysis, takes 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 who BioMérieux’s biggest competitor will likely be, Laayoun, with a theatrical glance over each shoulder, said that it was Roche. (Chris Chamberlain, a medical genetics specialist at Roche, chaired the first day of the two-day meeting. Chamberlain gave the opening remarks at the meeting and was the first presenter of the first day. Chamberlain called Laayoun’s presentation “tremendous.”)
“The competition in microbio- logy 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.”
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 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.
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,” said Laayoun. “But it will grow.”