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German MDx Startup Curetis Nets Roche Venture Fund, Forbion as New Investors


By Ben Butkus

German molecular diagnostics shop Curetis said today that it has secured an additional €9.6 million ($13.4 million) tranche as part of its series A financing round, attracting Roche Venture Fund and Forbion Capital Partners as new investors.

With the latest tranche, Curetis has raised a total of €34.1 million to date in its Series A financing round. The company will use the most recent funding, in addition to the €4.5 million it netted in April, to begin clinical trials for its fully automated, multiplexed endpoint PCR-based molecular diagnostic platform and associated pneumonia assay panel, CEO Oliver Schacht told PCR Insider.

If all goes well, Curetis hopes to launch the pneumonia assay and testing platform, called Unyvero, as a CE-marked medical device in the spring of 2012. Simultaneously, the company is working with the US Food and Drug Administration to prep its platform for a separate clinical trial in the US next year, with the hopes of achieving 510(k) approval and attracting a commercial partner by the end of the year, Schacht said.

With Roche Venture Funds now on board, Curetis may have a leg up in wooing parent company Roche as a commercial partner, although RVF's investment came with "no strings attached," according to Schacht.

"It's a fair assumption that on the venture side they are a pure equity investor," Schacht said. "We haven't given any promises, or rights, or licenses as part of this deal. Basically it is a plain vanilla equity transaction. They are part of the Roche finance organization … so they have clear targets in making returns on their investments."

However, Schacht added that Basel, Switzerland-based RVF typically leverages its parent company's diagnostic expertise for diagnostic investment deals, just as it brings in Roche pharma experts for therapeutic deals. "From our end it is a great sign of validation that, after a lot of due diligence and looking at … our first product, that the PCR multiplexing capabilities that we bring to complex infectious diseases has convinced them, and they made the investment."

RVF representatives were not available for comment. Curetis' second new investor, Forbion Capital Partners, is a dedicated European life sciences venture capital fund with offices in Naarden, the Netherlands, and Munich, Germany, and has "quite a lot of molecular diagnostics know-how on its team," Schacht said.

In a statement, Holger Reithlinger, a partner at Forbion, noted that the Unyvero platform is expected to reduce the time it takes to identify potential pneumonia-causing pathogens and antibiotic resistance markers from days to hours.

"I was impressed by the ease of use, for the first time including the always-challenging sample preparation in the workflow, and the versatility of the platform allowing for further applications to come," Reithlinger said.

As part of the new financing, Reithlinger has joined Curetis' board of directors. Meantime, Roche will get an observer on Curetis' board.

Curetis was founded in 2007 by former employees in a medical diagnostics venture group at consumer-electronics giant Philips with the goal of commercializing an inexpensive, benchtop, cartridge-based nucleic acid molecular testing platform.

The company leveraged know-how and basic technologies cultivated at Philips, but has developed the bulk of its platform and intellectual property in house, Schacht said.

The Unyvero platform combines a proprietary universal sample prep method with cartridge-based endpoint PCR and array-based detection on a touchscreen benchtop instrument with dedicated software.

Schacht said that the biggest piece of innovation in the Unyvero platform "is bringing together a lot of well-tested and well-established technologies and combining them in a touchscreen, easy-to-use instrument" that can be run in a "couple minutes' time."

However, the platform does feature a few patent-pending innovations conceived of at Curetis, most importantly the universal sample prep, which Schacht said is often internally referred to as a "bead mill on steroids."

"It allows you to take something like really gluey sputum, or aspirate, a lavage, maybe something that has blood in it … and run the same protocol," Schacht said. "You put it in our sample tube and put that into the lysator, and it will basically combine mechanical, thermal, and enzymatic lysis all at the same time in the same instrument."

The lysed sample then gets put into the Unyvero disease-specific cartridge, which performs multiplexed endpoint PCR. "If you use real-time PCR you are limited in the number of colors and dyes you have available," Schacht said. "This typically means five colors and one for the control.

"We deliberately went for the endpoint … with eight different PCR chambers in each cartridge," he added. "Each one runs a multiplex endpoint PCR somewhere in the ballpark of a four-, five-, or six-plex. Each of these chambers can run a different temperature profile, so you really optimize each multiplex reaction for … annealing temperatures, and don't have to worry about analyte cross-reactivity."

This is especially important considering that Curetis will be targeting infectious diseases that can benefit from a high degree of multiplexing in order to identify different strains and antibiotic resistances. For instance, the company's first test panel for pneumonia will contain 17 pathogens and 22 antibiotic-resistance markers.

Following PCR amplification, the gene products are "pumped through" a porous membrane containing arrayed hybridization probes, and detected with a simple imaging system.

"Sometimes with hybridization arrays on a surface, you could be talking about overnight for hybridization times," Schacht said. "Here we're talking about a 20- to 30-minute hybridization in this porous membrane. Technologically by itself, it's nothing terribly new, but in that little PCR chamber, where amplification and detection is combined in a unique way — that's where we have patent protection, and that makes it unique in every cartridge."

In May, Schacht told PCR Insider that the company had hoped to complete an approximately 1,000-subject, prospective clinical trial for Unyvero and the pneumonia panel at four European sites by early 2012, then launch the system in Europe about halfway through the year. He also said that Curetis was hoping to begin US clinical trials in the second half of this year with the goal of filing for 510(k) approval in the US in early 2012 (PCR Insider, 5/19/2011).

The US commercialization timeline has been pushed back a bit, but since that time, the company has successfully manufactured and tested 10 of the Unyvero platforms and is ready to ship them to the European testing sites, now numbering five, to progress with European clinical testing and commercialization as planned, Schacht said.

The new funding not only supports that effort, but "also allows us very aggressively to work toward a US FDA approval trial, which we're also planning on starting here in the next couple months, targeting 2012 for running the US prospective, multi-center trial, and then submitting to the FDA for 510(k) clearance," likely by the end of 2012, he added.

The US trial, he said, would likely be larger than the European one, with perhaps up to 2,000 subjects participating at three to four sites. "That's going to be subject to some of the discussion we're having with the [FDA]," he said.

"And we'll also be very proactive and aggressive to some extent on the business development front on bringing on board a true strategic partner for our US and global commercialization," Schacht said. "When the time is right and the product is close to getting approved by the FDA, hopefully we'll be in the position to team with the right commercial partner."

Beyond the pneumonia panel, Curetis also has in its development pipeline multiplexed tests for surgical site infections, tuberculosis, and sepsis. Schacht said that it is too early to say which of these will follow the pneumonia test panel, and that such a decision will ultimately "depend on our commercial research, and what our potential partners will be most interested in. But the timeline should be around the end of 2012 that we'll start looking at other applications beyond pneumonia."

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