Commercialization Agreement to Promote Rapid Mycoplasma PCR Test

Two Swiss life science companies have signed a coexclusive distribution agreement for the commercialization of the first PCR-based Mycoplasma assay for biosafety testing of approved biological products.

According to the agreement Lonza Biosciences (Basel, Switzerland), a leading supplier to the pharmaceutical, healthcare, and life science industries will market the Roche (Basel, Switzerland) line of "MycoTOOL" PCR assays. MycoTOOL is the first commercially available Mycoplasma PCR-test approved by the European Medicines Agency (EMA) to replace traditional Mycoplasma tests (cell-dependent and cell-independent culture methods) during pharmaceutical production.

In addition to selling the MycoTOOL assay, Lonza will offer contract-testing services using the MycoTOOL test system.

"Roche and Lonza share the rare combination of being both consumers and providers of pharmaceutical quality control and diagnostics products. This internal integration of user and manufacturer helps ensure products align properly with user requirements and capabilities. The unique perspective of being a user of the very products you sell provides insight unattainable from the outside looking in. We are pleased to be working with Roche in bringing this advancement to our colleagues," said Lukas Utiger, head of Lonza BioSciences.

Robert Yates, head of Roche Applied Science, said, "Lonza's reputation for quality and customer care gives us confidence that MycoTOOL will be placed in the right applications for customers who wish to perform rapid Mycoplasma testing in-house, and for those who prefer to send their samples to a qualified outside laboratory for testing."

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