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Carpegen Debuts POC MDx System; Seeks Partners to Move Beyond Periodontal Testing

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Carpegen, a German company providing real-time PCR-based testing services to dental practices, this week unveiled a beta version of its benchtop, cartridge-based, sample-to-answer molecular diagnostics platform.

Having used funding from the German government to move the platform from prototype to a beta version, Carpegen and development partner Systec are now seeking corporate partners to build out the system's test menu for clinical diagnostics and applied markets.

In the meantime, Carpegen will continue to develop the system as a point-of-care device for periodontal testing with the hopes of launching a full commercial product near the end of 2013, Carpegen CEO Antje Roetger told PCR Insider recently.

Carpegen unveiled the platform, called Gyronimo, this week at Bio-Europe 2012 in Hamburg.

"We are now collecting samples from periodontal patients to analyze them with the prototype, because the first version is for dental diagnostics," Roetger said. "We are also looking for corporate partners from the diagnostics and pharma sector, but even from the non-medical sector to develop the system into other fields of application."

Carpegen first unveiled a prototype of its platform in 2010 (PCR Insider, 6/3/2010). The system uses a circular cartridge built from three molded plastic discs containing microfluidic circuits. The discs are stacked on top of each other but can rotate independently, allowing the formation of various microfluidic channels for sample processing and detection.

The cartridge is placed into a benchtop instrument about the size of a computer printer, which runs the assay by rotating the various components and performing sample processing, nucleic acid extraction, PCR setup, fluorescence-based data acquisition, and raw data analysis. The platform uses magnetic beads combined with Carpegen's own lysis buffers and reagents for sample preparation, and TaqMan-based real-time PCR, and Carpegen claims that most tests will take from 30 minutes to an hour to complete.

According to Roetger, the system has remained more or less the same since the company first introduced it, although it has undergone a few important changes. For instance, "it's now optimized for user friendliness — you just have to put the [test cartridge] in … like a CD player," she said. "And all the reagents we are using are now in the lyophilized form, whereas before they were in liquid form."

The lyophilized reagents can also be stored for a longer period of time, up to a year. In addition, although the current version of the platform only accepts "paper point" periodontal samples, Carpegen is working to enable the use of buccal swabs and blood.

"These are not ready but we plan to put the sample as raw as possible into the system, because it has to be very easy for the user," Roetger said. "The user should not have to know really anything about laboratory work, and this will be possible."

Carpegen originally received approximately €2.3 million in funding from the German Federal Ministry of Education and Research to develop its first prototype. Since then the company has been awarded another €1.6 million from the agency to move the platform to its current iteration.

That funding, which Roetger said should suffice through 2013, also includes provisions for Carpegen to develop assays for the system outside the periodontal realm. She said that the company is looking into tests for methicillin-resistant Staphylococcus aureus and a number of viruses, as well as gram-positive bacteria.

"The periodontal bacteria are easier to extract, because they are all gram negative," she said. "But we need both [gram-negative and gram-positive] for MRSA and a number of different germs for hospital-[acquired] infections. The system is extremely suitable for [diagnosing] HAIs."

Carpegen's assay-development expertise is somewhat limited, however, owing to the company's small size and currently brutal private funding environment, and as such it is looking to build out its test menu with corporate partners.

"In Europe at the moment it is very difficult to get venture capital, so you have to either get federal funds or [work with] corporations," she said. "VC is really difficult at the moment."

The company has cited environmental testing and food safety as two possible application areas.

Carpegen has not yet published data on the performance of its platform or assays, and Roetger said such publications are in the pipeline, as the company is working with the University of Bonn to collect patient samples for more rigorous studies.

But at Bio-Europe this week, Roetger showed potential partners data on Gyronimo's performance versus in-house real-time PCR assays for a number of targets using a Roche LightCycler platform.

"The sensitivity was comparable to our in-house test, and that was a requirement of the new platform," she said. "The benchmark is our in-house system, and we have achieved that. It's very sensitive — we can detect only a few bacteria in the sample."

While Carpegen works on forging development partnerships, it will continue to offer in-house real-time PCR-based testing for periodontal disease, and will likely continue to do so after Gyronimo is commercialized, Roetger said.

"We are selling services, and I think we will [continue] selling services even after this is on the market," she said. "Some customers may only send one sample in a month [for testing], and they maybe wouldn't purchase a system."

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