“May 9, 2005 Intelligence: Late Breaking Lab News”

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Tight-lipped executives at Meridian Bioscience, Inc. have yet to speak in public on any aspect of how live H2N2 influenza virus found its way into the virology proficiency test kits it shipped to thousands of labs on behalf of four lab proficiency testing organizations. Meridian, based in Cincinnati, Ohio, may be reluctant to speak publicly because it has a history of problems with the Food and Drug Administration(FDA). In 2001, FDA criticized Meridian for failings in the company’s manufacturing process for medical test kits. Meridian pulled 30 products from the market. It laid off 52 workers and absorbed a net revenue loss of $9 million from that incident. In March 2004, Meridian responded to an FDA finding by recalling certain production lots of a diagnostic test kit that was generating false results.

ADD TO: Meridian

Meridian’s revenues total about $80 million annually. It “manufactures and distributes…diagnostic test kits, purified reagents and related products.” Last year it sold about $3 million of products to the College of American Pathologists. Its stock symbol is “VIVO.”

CANON PREPARES TO ENTER MEDICAL DNA CHIP MARKET

Canon, Inc., the world’s largest manufacturer of office machines, announced plans to commercialize DNA chips for applications in medical diagnostics. Canon believes it can incorporate the bubble-jet technology it uses in printers to the mass production of DNA chips. It is targeting oncology and infectious disease testing. It believes it can apply its expertise in manufacturing to reduce the cost of DNA chips and make them more cost-effective to use in both research and clinical diagnostics.

ADD TO: Canon, Inc.

Canon becomes the latest company to announce major investments in bio-medical products. Currently the leader in “lab on a chip” production is Affymetrix, Inc., based in Santa Clara, California. The lure of the medical marketplace has encouraged companies like Toshiba Corp. and Toppan Printing Co. to develop similar types of DNA chips for use in drug development and similar medical applications. Canon’s interest in developing a “lab on a chip” business is more evidence that the market for molecular diagnostics is expected to be huge, fueled by new technologies in genetic medicine.

Microbiologists are seeing a growing proportion of drug- resistant staff infections occurring outside hospitals and nursing homes. CDC researchers reported their findings in a study published in the Journal of the American Medical Association (JAMA) recently. In communities studied, which included Baltimore, Atlanta, and parts of Minnesota, up to 17% of all drug-resistant staph infections were transmitted in the community and had no apparent links to healthcare settings like hospitals and skilled nursing facilities. The more resistant strains showed up among inmates, children, and athletes.

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