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Curetis Looks to Expand to Medium-Multiplexed Testing With New Gyronimo qPCR Platform

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NEW YORK (GenomeWeb) – After announcing yesterday that it has acquired the Gyronimo qPCR platform from co-creators Systec and Carpegen, German molecular diagnostics firm Curetis has provided additional details on how it plans to integrate the platform with its Unyvero system and develop diagnostic assays for it.

The acquisition included a €5 million ($5.3 million) cash payment, €2.5 million in milestone payments to be made upon CE marking and US Food and Drug Administration clearance of the platform and a first cartridge, and potential for royalty-based earning of up to €9 million.

Curetis had been searching for a way to evolve the Unyvero system, and had considered both internal development and external acquisitions, CEO Oliver Schacht said in an interview. The firm's IPO in November last year served to accelerate the process, he said, since more privately funded companies began showing it assets.

Curetis' Unyvero system is a cartridge-based molecular diagnostics platform capable of testing for 40 to more than 100 targets from a single patient sample using endpoint PCR coupled with array-based detection. But that unique high level of multiplexing is sometimes much more than customers need, Schacht said. The firm focuses on critical care and severe infectious disease in hospitalized patients, and conversations with hospitals also suggested they need small, fast panels for things like antibiotic stewardship.

"We have all these broad syndromic panels, but our customers told us there are a number of questions where 10 to 20 diagnostic targets is really all they need," Schacht said. But there are also clinical indications that require quantitation abilities, "which only real-time PCR will give you," he said.

In the end, Curetis considered about a dozen different systems from private companies in Europe and North America.

It focused on cartridge-based, sample-to-answer solutions in the medium multiplexing space, capable of detecting anything between eight to 10 targets at the low end, or 30 to 40 at the high end.

"There are a number of companies ... in Europe, the likes of Stat Diagnostics or Atlas Genetics, and you have companies in North America, such as GenePOC, who have interesting platforms," Schacht said.

All of these have different angles and advantages, and for Schacht it boiled down, in part, to the ease of integration in terms of hardware and software. Also important was Curetis' ability to have full control from day one over development of the platform and content, "rather than acquiring something that has legacy content that may not be the best strategic fit for Unyvero."

In the last few months the firm did a deep-dive due diligence on the Gyronimo platform, and concluded that it fit the bill nicely.

The two platforms will now be integrated. "Unyvero today consists of three boxes — the cockpit, which is basically a computer touchscreen, a lysator for automated sample prep, and then the analyzer which runs Unyvero cartridges," Schacht explained. The Gyronimo will effectively be another Unyvero analyzer, only smaller, and with a different cartridge. Placement could then be flexible, with a Gyronimo system hooked to the cockpit and lysator, or completely standalone with a small touchscreen.

Thus, the Gyronimo component — a cube about 10 inches on each side, with turnaround times of as little as one hour — will be a separate box, "but from a look and feel, and from an engineering, manufacturing, and software protocol standpoint, its all going to be fully integrated into the overall suite of Unyvero products," said Schacht.

The Unyvero analyzer is a roughly 20-inch cube, and to perform the massive PCR multiplexing and microarray detection its cartridges require 88 injection-molded plastic pieces. By comparison, the Gyronimo cartridge, which enables 10 real-time PCR channels, only requires assembly of six plastic parts to create cartridges. "It is a very elegant design, with rotating disks," Schacht said, noting that patents covering the technology have been issued in the US, Canada, China, and Europe.

Because of the relative manufacturing simplicity, the firm is looking at a cost of goods for the Gyronimo cartridge that is between half and one-third the cost of the Unyvero cartridges. The latter, at scale, cost slightly less than €30, so the Gyronimo cartridges would cost "somewhere in the €10 to €15 ballpark," Schacht said.

"It's not meant to be the 'two-buck chuck,' simple, one-assay screening test," he said, but rather, will potentially be competing with platforms that have up to 30 analytes, which he noted are in the €30 range.  

The competitive cost of goods will give the firm flexibility in developing products that may have average selling prices in the $50 to $100 range, and still maintain "very attractive" gross margins, he added.

The Gyronimo developers created the platform with rapid bacterial pathogen testing for dental samples in mind, and the acquisition agreement allows Systec and Carpegen to maintain assay development in the dental, environmental, and food testing spaces.

The potential test menu for the Gyronimo component at Unyvero has not been locked in, but Schacht said it could potentially include panels in four areas: infection control, viral testing, CNS infections, and assays for immunocompromised patients.

The firm has not given any guidance on which test it may develop first, but "it is safe to assume that those are all very valid from a customer and market requirements perspective, and we're going to figure out how we are going to prioritize them," Schacht said.

Curetis expects to complete development of Gyronimo and obtain CE-IVD marking sometime after 2018. Meanwhile, clinical trials of the Unyvero system aimed at US regulatory clearance have been completed already, and the firm expects to submit the platform to the FDA with a 40-target lower respiratory panel by the end of this year. Schacht then expects "mid-2017 feedback, and, hopefully, a clearance decision, and then we will launch Unyvero in the US next year." The company has already established a core team based out of San Diego, he noted.

The firm has not provided any timeline for FDA submission of the Gyronimo component, but it will likely be taking the platform through that regulatory process as well, Schacht said, adding that fewer analytes will make for much simpler clinical trials.

"From our perspective, this is a perfect match and it is going to leverage all of the infrastructure we already have, be it in R&D, clinical trial operations, regulatory, and also on the commercial side," Schacht said. The smaller panel tests will also be marketed to the same hospitals and customer accounts in Europe and the US, as well as elsewhere in the world, that are already using Unyvero, he added, "so for us this really synergistic and it is going to take the company into the next phase of growth."