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Germany's Curetis Begins Clinical Trial for MDx Platform, Pneumonia Test Cartridge

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Germany's Curetis has initiated a prospective clinical trial in the European Union for its Unyvero molecular testing system and P50 Pneumonia test cartridge, the company said in February.

The prospective, international, multi-center trial will enroll as many as 1,000 hospitalized patients suspected with a lower respiratory tract infection. Trial coordinators will pre-process patient samples such as sputa, aspirates, or bronchial lavages on the Unyvero Lysator, then transfer the processed samples to the Unyvero P50 cartridge, which is analyzed on the Unyvero Analyzer.

Curetis, based in Holzgerlingen, said that the primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to the gold standard of microbiology culture. Trial sites include the University Hospital Tübingen, the Heart and Diabetes Center Bad Oeynhausen, and the University Hospital Jena, all in Germany; as well as the Hospital Clinic of Barcelona in Spain and the Erasme Hospital in Brussels, Belgium.

Ingo Autenrieth of the University Hospital Tübingen will serve as principal investigator. Curetis said it expects interim topline data from the trial in the spring.

Founded in 2007 by former employees of a medical diagnostics venture group at Philips, Curetis has developed the Unyvero system, an inexpensive, benchtop, nucleic acid molecular testing platform that combines a proprietary universal sample prep method with cartridge-based endpoint PCR and array-based detection.

The system will feature a touchscreen interface with dedicated software and is expected to provide test results in a few minutes' time, company executives have said.

In October, Curetis said that it secured a €9.6 million ($13.4 million) tranche as part of its ongoing series A financing round, attracting Roche Venture Fund and Forbion Capital Partners as new investors (PCR Insider, 10/27/11).

The company had previously raised €4.5 million in May 2011 (PCR Insider, 5/19/11); and has thus far raised a total of €34.1 million in four tranches.

The company also has in place a collaboration with Sanofi Pasteur, inked in December, for the potential use of the Unyvero platform in a future undisclosed clinical trial.

"The start of the clinical trial is the next important milestone for Curetis after the opening of our clean room cartridge production facility in Bodelshausen, the signing of our Sanofi Pasteur collaboration agreement, and our most recent financing with Forbion and Roche," Curetis CEO Oliver Schacht said in a statement. "If successful, it will further strengthen the data package for our market launch, in addition to the CE mark for the Unyvero System and the Unyvero P50 Pneumonia Cartridge."

In addition, Schacht said that the data may be used to augment a planned prospective trial in the US to obtain US Food and Drug Administration clearance. That trial is expected to start later this year.

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