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Stat-Diagnostica Readies Combined Immunoassay, PCR Platform for 2017 Launch

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NEW YORK (GenomeWeb) – Barcelona-based Stat-Diagnostica is developing a one-step, fully-integrated, cartridge-based immunoassay and molecular diagnostics system called DiagCore.

The firm received €25 million ($28.5 million) in Series C financing this week and anticipates a 2017 launch of the platform.

The concept of combining immunoassays and PCR-based diagnostics has been explored by several companies, but no one has yet optimized both of these technologies on one platform, Stat-Diagnostica Co-founder and CEO Jordi Carrera told GenomeWeb in an interview today.

"We intend to have the same analyzer, but use two different cassettes — one to run the molecular technique and one to run the immunoassay – to get the best performance out of each technique, and I think this is a different approach than what other companies have done in the past," Carrera said.

Product development is nearly completed, he said, so the new funding will now be applied toward finalizing manufacturing capabilities, validating the first products, and putting together a marketing and sales organization in advance of the 2017 launch.

The platform is now more advanced than it was when it was previously described by GenomeWeb in 2013, but the principles and concept have remained the same since early development began in 2011.

The consumable cartridges have all reagents onboard in dry and wet chemistries, with 12-month shelf lives to enable use in very decentralized settings.

The analyzer, which is about the size of a PC, also performs a fully automated sample prep for PCR. In fact, after a sample is added and the cassette is placed in the analyzer, all subsequent steps are automated as well. The highly multiplexed PCR consumable has also been developed so that is uses standard lab technologies. "Our vision is to have decentralized testing with lab-like performance," Carrera said.

This strategy will make menu development faster, he said, and will also cater to the critical care segment, where high-quality tests are needed. Specifically, Carrera said the firm intends the DiagCore to be used in physicians' offices and emergency rooms.

The immunoassays will use different cassettes, but "the vision is to have high sensitivity to complement and reinforce the molecular platform in the critical care setting," Carrera said. He declined to disclose the immunoassay analytes in development.

DiagCore is a closed system, and will have accompanying IVD assays. There is a pipeline of assays in development to build up the menu following launch. While Carerra could not disclose specific tests, he said the first six or seven products will be in the infectious disease space. But, Stat-Diagnostica is exploring other areas as well.

The first product will be a 22-target multiplex test, and the firm plans to sell it at a price similar to competitors in the marketplace, which, depending on the geography, is in the €120 to €160 range. The platform will also likely be commercialized using a reagent-rental model, Carrera said.

The cartridges are single-use, but the system is modular. Up to eight modules can be run together to enable parallel testing and meet throughput requirements, and tests take between 30 and 80 minutes.

A somewhat similar platform for highly-multiplexed rapid diagnosis in critical care settings was recently launched by Enigma Diagnostics. That platform, however, does not include an immunoassay option.

Rheonix, meanwhile, is developing a "self-confirming" microfluidic cartridge that can run molecular tests and immunoassays simultaneously, but the current iteration of that system uses loop-mediated isothermal amplification.

Stat-Diagnostica will initially market the platform in Europe, but has plans to transition to the US. The system has been designed based on CLIA waiver guidelines, "so that the day that we go into the US after the approval, we get classification as 'waived' and can really decentralize the test to physician office labs and clinics."

To reach that market, Stat-Diagnostica is also in the process of implementing a marketing strategy, but Carerra could not disclose specifics. The platform will be demonstrated at diagnostics-related conferences and events toward the end of the year, and Stat-Diagnostica will also then present performance data.

"We have tried to be really under the radar until we had something really prepared to be launched," Carerra noted. 

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