By Ben Butkus
Roche said this week that Swiss pharmaceutical products and services firm Lonza will distribute Roche's PCR-based mycoplasma assay for pharmaceutical quality control under a co-exclusive agreement.
As part of the pact, Roche's MycoTool detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation, the companies said. Lonza also offers contract testing services using the MycoTool test.
MycoTool is an endpoint assay that combines PCR amplification with gel electrophoresis to provide same-day detection of more than 90 species of Mollicute, including Mycoplasma, Spiroplasma, and Acholeplasma, due to the use of a universal primer design, according to Roche's website. The test can run on several different types of thermal cyclers, a Roche spokesperson said.
In July 2009, MycoTool became the first commercially available nucleic acid test for mycoplasma when the European Medicines Agency approved release testing with the kit for a Roche pharmaceutical product; and the US Food and Drug Administration approved the underlying concept of MycoTool for validation and release testing of seven pharmaceutical products from Genentech, Roche said.
Roche's kit has been "very successfully" commercially available since that time, a spokesperson told PCR Insider this week. Also, since MycoTool launched, several other companies have introduced molecular tests or services for mycoplasma detection, including American Type Culture Collection, Millipore, Life Technologies, and Pall.
Even Lonza has been developing its own PCR-based tests for pharmaceutical quality control, including mycoplasma detection, under the brand name MicroCompass. In October, Lonza signed an agreement with BD Diagnostics to develop several of the manual MicroCompass assays for use on the BD Max fully automated testing platform (PCR Insider, 10/28/10).
In an e-mail to PCR Insider, Orla Cloak, a commercial development manager in Lonza Biosciences' testing solutions division, noted that Lonza offers several products and services for mycoplasma testing, including its MycoAlert enzyme-based screening assays, commonly used for research and in-process testing.
"Our industry urgently needs rapid microbial testing solutions," Cloak said. "Traditional culture-based detection methods have not kept pace with our industry’s needs. However, providing acceptable alternative methods is not a simple task. There is no single 'black-box' solution to the many complex challenges microbiologists face today."
As such, Lonza continues to collaborate with multiple industry players to develop and commercialize rapid microbial testing solutions.
Lonza found Roche's MycoTool attractive because it "is commercially available now, runs on existing PCR platforms that are commonly available, and has secured the necessary regulatory approvals," Cloak said, adding that the company will use its global sales, distribution, service, and contract testing facilities to offer MycoTool to the pharmaceutical market.
In the meantime, Cloak said, Lonza is collaborating with BD to commercialize an "easy-to-use, automated platform with true load-and-walk-away functionality" on the BD Max platform. "Lonza’s current microCompass assays are being ported onto this platform to meet customers’ needs and our microCompass assay menu will continue to expand," she said.
Regarding Roche's distribution deal with Lonza, Robert Yates, head of Roche Applied Science, said in a statement that 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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