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Curetis, Heraeus Medical Partner to Develop MDx Test for Implant, Tissue Infections

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German molecular diagnostics firm Curetis and technology group Heraeus Medical said today that they have signed an agreement to jointly develop a cartridge for use on Curetis' Unyvero system to detect pathogens and antibiotic resistance in implant and tissue infections.

Terms of the agreement call for Heraeus and Curetis to co-fund product development. Heraeus' customers will be given access to the Curetis Unyvero nucleic acid testing platform, and Curetis will pay a sales commission for any customers that Heraeus refers to Curetis.

According to the companies, no licensing is involved. Curetis will retain full control over commercialization both directly in Germany, Austria, and Switzerland, as well as via its international distributor network. The resulting Unyvero cartridge and application will be a Curetis-labeled in vitro diagnostic.

Curetis' Unyvero platform is an inexpensive, benchtop, nucleic acid molecular testing system that combines a proprietary universal sample prep method with cartridge-based endpoint PCR and array-based detection.

The system features a touchscreen interface with dedicated software and can provide test results in a few minutes' time, with minimal operator intervention and without the need for skilled staff or specialized infrastructure, according to the company.

Under today's agreement, Heraeus, which develops, manufactures, and markets products to improve bone and joint surgery and manage infections, will be able to offer this system to its customers. One key application area of the collaborative effort will be in orthopedics; for example, to diagnose infections after knee and hip replacement surgeries, the companies said.

The companies also said they expect the new implant and tissue infection cartridge to be used in general surgery, as well to diagnose infections caused by biofilms in abdominal surgery infections, diabetic foot, or burn wounds, for example.

Currently used non-molecular testing methods may take one to two weeks to produce results from such biofilm samples, often leading to prolonged empiric treatment, follow-on surgeries, and increased morbidity and healthcare costs, the companies said.

Curetis and Heraeus said that they have partnered with various opinion leaders in Germany, Switzerland, France, the UK, and Scandinavia to determine the pathogens and antibiotic resistances that need to be included in the diagnostic panel of the new cartridge.

The partners expect to complete assay development, clinically validate the product, and obtain CE marking throughout next year, and to launch the cartridge in the EU by the end of 2013. The product is likely to include more than 40 and possibly up to 50 analytes, the companies said.

"There is a need for a highly accurate implant/orthopedic infection test for mixed pathogens," André Kobelt, CEO of Heraeus Medical, said in a statement. "The Unyvero platform provides customers with superior molecular diagnostics solutions to combat serious infections faster and more effectively, as well as potentially improving the management of latent orthopedic infection."

Curetis CEO Oliver Schacht added in a statement that “the collaboration with Heraeus Medical provides us with the opportunity to leverage our Unyvero platform once again in an important indication."

In May, Curetis received the CE Mark for its first Unyvero cartridge, the P50 pneumonia cartridge, which simultaneously analyses 39 DNA targets commonly involved in pneumonia-causing infectious agents (PCR Insider, 5/17/2012).

Curetis and Chapel Hill, NC-based Cempra last month announced a collaboration to use the Unyvero pneumonia test in Cempra's phase III trial for its oral drug for community-acquired bacterial pneumonia.

Curetis is also developing Unyvero cartridges for diagnosing surgical site infections, bloodstream infections, and tuberculosis.

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