Molecular diagnostics firm Curetis is buying Carpegen and Systec’s real-time, cartridge-based qPCR platform, Gyronimo, for an initial €5 million ($5.31 million). Curetis aims to integrate the platform into its own portfolio of Unyvero diagnostic systems for infectious diseases. The firm claims the Gyronimo technology will allow it to develop Unyvero into a broad diagnostic platform with capabilities ranging from rapid, one-hour testing for 10+ diagnostic targets, to highly multiplexed syndromic assay panels that can test for 100 diagnostic targets in four to five hours.

Under the terms of the deal, Curetis is acquiring all Gyronimo Platform assets, including prototype systems, the complete IP and patent portfolio, and a non-exclusive license to background IP and know-how. Curetis has also been granted exclusive worldwide rights to the Gyronimo platform, including the rights to sublicense, partner or sell the technology. Carpegen and Systec retain rights in the field of dental testing, and environmental and food safety testing. The two firms could receive another €2.5 million ($2.66 million) in regulatory milestone payments if the platform and an initial cartridge achieve CE marking and FDA approval, plus up to €9.5 million ($10.10 million) in sales royalties. News of the acquisition comes the day after Curetis confirmed receipt of a €25 million ($26.57 million) senior, unsecured loan from the European Investment Bank.

The Gyronimo platform offers qualitative and, where required, quantitative real-time PCR testing. The cartridge-format platform can generate results in as little as 60 minutes, and can carry out up to 10 multiplex qPCR reactions in parallel from a single sample, which makes the system ideally suited to medium multiplexing applications, Curetis claims.

The firm says it doesn’t expect to complete CE marking of any IVDs prior to the latter part of 2018. It does expect the Gyronimo cartridges to work out significantly cheaper than its own Unyvero cartridges, and those of other MDx multiplexing systems. Oliver Schacht, Ph.D., CEO, Curetis, maintains that integrating the Gyronimo technology into the Unyvero platform will enable the development of new infectious disease tests for the hospital market.

“Gyronimo's advanced product development stage, its speed, quantitation ability, low cost of goods and mid-range multiplexing features are unique,” Dr. Schacht commented. “It is therefore a natural next step in the development of our Unyvero Platform and we do not intend to develop it as a separate system, but rather as an integral and modular part of our overall Unyvero Solution. It expands and provides our product portfolio with a remarkable competitive edge, i.e., an unmatched diagnostic bandwidth ideally suited for any particular clinical application from as few as five or 10, via 20 to 30, and up to over 100 markers.

Curetis currently markets its Unyvero System and three application cartridges for pneumonia, implant and tissue infections, and bacteremia. A cartridge for intra-abdominal infections is in the latter stages of development, and the firm’s pipeline includes tests for for sepsis, host response, urinary tract infections, cardiology-related infections and an extended panel for respiratory tract infections.

In October, Curetis reported positive topline data from a U.S. trial comparing its Unyvero instrument platform and Unyvero lower respiratory tract (LRT) cartridge, with microbiological culture for the detection of lower respiratory tract infections. The firm said that based on the results it was preparing its final package for a 510(k) submission of the Unyvero platform and the LRT cartridge to FDA.








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