Rapid Molecular Tests To Combat Healthcare-Associated Infections

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Detecting Disease

3M and Gen-Probe announced that the companies have formed an exclusive worldwide collaboration to develop and commercialize rapid, easy-to-use nucleic acid tests to detect certain dangerous healthcare-associated infections such as methicillin-resistant Staphylococcus aureus.

"This collaboration further strengthens our medical diagnostics business and leading infection prevention portfolio by offering hospitals new rapid diagnostic tests to detect the presence of certain potentially destructive microbes before they spread and possibly infect other patients and workers," said Chuck Kummeth, division vice president, 3M Medical Division. "We are excited to be working with Gen-Probe, an exciting and proven market leader, to bring this advanced diagnostic technology to the market."

"We are delighted to work with one of the world's leading infection control companies to employ our proprietary molecular technologies in the fight against healthcare-associated infections," said Hank Nordhoff, Gen-Probe's chairman, president and chief executive officer. "This collaboration exemplifies all the strategic elements we look for as we seek to broaden our business: a significant unmet medical need, a commercially attractive market, and a terrific partner."

Under the terms of the agreement, Gen-Probe will be responsible for assay development, which 3M largely will fund. 3M will be responsible for integrating these assays onto one of its proprietary integrated instrument platforms, an easy-to-use molecular testing system that is expected to generate results in as little as one hour. Gen-Probe will conduct bulk manufacturing of assays, while 3M will produce disposables for use on its instrument. 3M will manage clinical trials and regulatory affairs, and handle global sales and marketing with co-promotion assistance from Gen-Probe's sales representatives. 3M has agreed to pay milestones to Gen-Probe based on technical and commercial progress, and the companies will share profits from the sale of commercial products.

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3M and Gen-Probe also are collaborating in the area of food safety through an agreement announced in December 2006 to develop rapid molecular tests that enhance food safety and increase the efficiency of testing for food manufacturers.

3M and Gen-Probe are recognized innovators in their respective fields. For example, both companies have received the National Medal of Technology, the nation's highest honor for technological innovation. The medal is awarded to individuals and companies who "embody the spirit of American innovation and who have advanced the nation's global competitiveness."

In the United States, the Centers for Disease Control (CDC) estimate that approximately 90,000 deaths annually are attributable to HCAIs(i). The CDC issued new guidelines in October 2006, outlining strategies to prevent the spread of drug-resistant infections in healthcare settings. The CDC recommended that healthcare facilities that do not improve their healthcare-associated infection rates implement screening of patients at high risk for carrying drug-resistant bacteria.

In the United States, current infection prevention patient screening activities include no screening, traditional cultures that provide results in 48 hours, or limited use of molecular diagnostics. 3M and Gen-Probe plan to introduce innovative molecular products that will simplify the diagnostic testing process and provide more rapid results than traditional microbiology tests for the detection of key microbes such as MRSA, vancomycin-resistant enterococcus, and Clostridium difficile.

HCAIs also are a persistent challenge for hospitals worldwide. A prevalence survey conducted under the auspices of the World Health Organization (WHO) in 55 hospitals in 14 countries, representing four WHO Regions (Europe, Eastern Mediterranean, South-East Asia and Western Pacific), showed an average of 8.7 percent of hospital patients had HCAIs. At any time, over 1.4 million people worldwide suffer from infectious complications acquired in hospitals(ii).

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