A Medical Device Daily

3M (St. Paul, Minnesota) and Gen-Probe (San Diego) said they have formed a worldwide collaboration to develop rapid, easy-to-use nucleic acid tests to detect certain dangerous healthcare-associated infections (HCAIs) such as methicillin-resistant Staphylococcus aureus (MRSA).

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 integrated instrument platforms, an easy-to-use molecular testing system that is designed 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 said it 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.

"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 VP of 3M Medical Division.

Likewise, Hank Nordhoff, Gen-Probe's president/CEO and chairman, said the "collaboration exemplifies all the strategic elements we look for … a significant unmet medical need, a commercially attractive market, and a terrific partner."

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

In the U.S., the Centers for Disease Control and Prevention (Atlanta) estimate about 90,000 deaths a year attributable to HCAIs. 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 HCAI rates implement screening of patients at high risk for carrying drug-resistant bacteria.

3M Health Care recently launched 3M Medical Diagnostics, a business unit that will focus on developing and commercializing rapid diagnostic product solutions for the detection of key infectious pathogens (Medical Device Daily, March 13, 2007).

In other new ventures news: OTN (South San Francisco, California) and Oncology Molecular Imaging (OMI; Jupiter, Florida) reported an exclusive strategic agreement. OTN, a physician services company, will provide customers with information and access to OMI's radiation therapy and diagnostic imaging services. OTN also has made an undisclosed investment in OMI's business,.

Oncology practices considering diagnostic imaging services, such as positive emission tomography (PET) and PET/CT, require understanding of regulatory and legislative issues and a commitment to handle various issues. OMI said it offers feasibility analysis, equipment selection, financing and capitalization of equipment, installation, maintenance, licensure and certifications, and ongoing education to physicians and staff on clinical integration and treatment guidelines.

OTN provides solutions that include technology, pharmaceuticals, supportive care products and medical/surgical supplies for the community-based treatment setting.

OMI provides PET and PET/CT diagnostic imaging services to oncology practices.

• Musculoskeletal Clinical Regulatory Advisers (MRCA; Washington), an independent orthopedic consulting firm, reported launch of a reimbursement division.

The hiring of Charles Schneider, VP of Reimbursement, and Amanda Briscoe, VP of Global Market Development, "has completed MCRA's integration of the four key technology value creators for a successful product launch," the company said.

MRCA said Schneider has worked with accounts ranging from hospitals to physicians to health systems to device companies. Briscoe brings to MCRA more than 12 years of executive experience, including the management of reimbursement strategy in compliance with federal, state and third party regulations for various companies.

The division will be headquartered, along with the clinical, regulatory, and intellectual property divisions, in MCRA's new Washington office. MCRA said its reimbursement team is positioned to assist outcomes anywhere between the product continuum, from concept phase to post-commercial launch.

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