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Germany's Curetis Adds $6.4M to Series A Financing to Prep MDx System for US Trials


By Ben Butkus

German molecular diagnostics firm Curetis said this week that it has netted an additional €4.5 million ($6.4 million) in its Series A financing round, raising its total to €24.5 million in three tranches.

Curetis will use the cash to accelerate the US commercialization of Unyvero, the company's benchtop automated DNA-testing platform, and its first cartridge-based test for multiple causative agents of pneumonia and antibiotic resistance markers, company officials said this week.

Curetis hopes to begin US clinical trials for the product in the second half of this year, with the goal of filing for 510(k) approval with the US Food and Drug Administration sometime in 2012, officials said.

In the meantime, the company is also using previously raised Series A funds to finish clinical testing and obtain CE marking for the product this year with an eye toward a commercial European launch in early 2012.

The first Series A tranche raised €18.5 million in 2009 from a consortium of venture capital funds, including Life Science Partners, BioMedPartners, the ERP-Stratfonds of the KfW Bankengruppe, and Aeris Capital, which had also provided Curetis €1.4 million in seed funding when it was founded in 2007.

Last year, existing investors pumped another €1.5 million into a second Series A tranche. The new €4.5 million deposit was subscribed to by existing investors and newcomer CD-Venture.

The reason for the most recent tranche "was really to allow us to accelerate our plans in the US," Curetis CEO Oliver Schacht told PCR Insider this week.

"Our original Series A financing would have been sufficient to complete and launch the product here in Europe, but we firmly believe that if you look at value creation in the molecular diagnostics space … that value gets generated through an FDA approval," said Schacht. "And we wanted to, in parallel, start an FDA approval trial."

Curetis was founded out of a now-defunct group at consumer-electronics giant Philips that focused on new medical diagnostics ventures. About half of Curetis' current employees — there are around two dozen of them — also have ties to the old Philips group.

A trio of that group who would become Curetis co-founders — Andreas Boos, Johannes Bacher, and Gerd Lüdke — "really started scouting opportunities and looking at technology and the IP landscape, and potential M&A opportunities," Bacher told PCR Insider. "And we built that program up [to where], at its peak, we were responsible for a headcount of almost 100."

However, Bacher claims that "in the end, no one wanted to be responsible for the cost we were generating, and Philips scaled down big-time, and was changing its strategic focus."

As such, the three executives made the decision to start Curetis with the goal of commercializing an inexpensive, benchtop, cartridge-based nucleic acid molecular-diagnostics testing platform.

Curetis' fledgling platform isn't the only technology to have sprung from the disbanded Philips group. Last February, Swiss molecular diagnostics firm Biocartis announced its acquisition of a molecular diagnostic platform from Philips that incorporates sample preparation and nucleic-acid amplification, and whose design was inspired by various consumer-electronics innovations (PCR Insider, 2/11/10).

Curetis, however, "did not take or license any IP out of Philips," Bachman said. "But we took a huge amount of experience with market, with basic technologies, and then we basically did a restart, with the big difference being … when the right point is to start assay development."

"Because we think of this as a system engineering effort … it only goes together if you have the assay guys tell you that temperature control is not tight enough, or that we need better fluid transport; as opposed to the engineering guy just saying I can only do 'X,' and how can you make your assay more stable?" Bachman added.

Schacht said that all of the technology behind the Unyvero platform was developed internally at Curetis, including the sample prep, "a unique lysis process that allows us to take any clinical sample, such as sputum, aspirate, bronchial lavage, or blood … all the way through to multiplexed assays, as well as the hardware and systems development."

Comparing Curetis' platform with Biocartis', Schacht said that in terms of the actual hardware, "from a PCR standpoint, they're actually very different. We've built a system for high-multiplexing applications. We're using endpoint PCR coupled with array-based detection. And we can detect, within a single cartridge, up to 100 analytes."

The Biocartis system, on the other hand, uses real-time PCR, "which basically limits you by definition to a handful of plex per chamber — and their system … is limited to about 25 analytes that they can look at," he added.

Curetis' first assay for Unyvero is a panel based on clinical guidelines in both Europe and the US that covers 17 bacteria that are potential causes of pneumonia and 22 antibiotic-resistance genes.

"So we're already approaching 40 analytes, which is something the Biocartis or other platforms simply can't do," Schacht said. "We firmly believe that starting out with a highly multiplexed application, and then … scaling down and simplifying applications that have lower-plexing requirements is much easier than starting out with a simple 'me too' MRSA test, which is something that some of our competitors are doing."

Those competitors, he said, will be going toe-to-toe "with the likes of Cepheid and others. And those are really simple assays comparatively … with less than a handful of markers. Trying to scale that up is a much more complicated endeavor."

Unyvero consists of a cube-shaped benchtop analyzer that contains a pair of independent random-access slots, into which a user "can put in one sample, start the process on that … and then you can slot in another sample for later and start that," Schacht said. "If you need higher throughput, you can stack up to eight of these systems."

Sample pre-processing and preparation, which involves homogenizing and liquefying the patient sample "such that in the end, once you put it in the cartridge, it's irrelevant what it originally was," Schacht said.

Once the cartridge is placed in the analyzer, a test takes anywhere between 2.5 and 3 hours to run, "so total time to result is somewhere in the three- to four-hour window," he said.

Curetis plans to finish pre-clinical validation work on the assay over the summer to establish baseline sensitivity and specificity, and to investigate potential assay-interfering substances, such as patient samples that have been treated with antibiotics.

"A lot of that work has already been done, and so far we have not found anything in our pre-clinical testing that would be an obstacle to us actually putting the first instrument out in the clinic in the second half of this year," Schacht said.

If Curetis can meet that timeline, it will then place the Unyvero platform and test cartridges at four clinical sites in Europe where scientists will compare it to the gold standard of classical microbiology.

The company expects to complete that trial by the first half of 2012, and then to launch the system and the pneumonia panel with the CE Mark for in vitro diagnostics about midway through the year.

Concurrently, the company will attempt to begin clinical trials in the US in the fourth quarter of this year. "We're going to do another three to four clinical sites in the US," Schacht said. "The size of the European trial is going to be approximately 1,000 subjects, and we're planning on adding another 1,000 subjects in the US; and then we're going to submit the combined data from both cohorts … to the FDA."

In anticipation of these goals, Curetis has partnered with US CRO Medical Device Consulting Services and in April submitted a pre-investigational device exemption booklet with FDA requesting a pre-IDE meeting. "And over the next few months we'll be answering their questions and designing our trial … and we're hoping to wrap up the US trial so that we can still submit a 510(k) in 2012," Schacht said.

Curetis also has in the development pipeline Unyvero assays for surgical site infections and tuberculosis; and is eyeing various oncology applications.

"We have pharmaceutical companies interested in using this platform in their clinical trials to pre-screen or pre-select patients for inclusion in their trial," Schacht said, although he declined to identify specific interested partners. "That could very rapidly then offer an installed base around the globe. We had not envisaged this, but were approached a while back about it."

"But our own menu is going to continue to be infectious disease-based; it will continue to rely on the unique selling point of the platform: high multiplexing, especially in areas where both pathogen detection and antibiotic resistance are key; and where time to result is absolutely critical," he said.

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.