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OpGen, a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced that its subsidiary Curetis has successfully met a key milestone in the development of the new Unyvero A30 RQ platform instruments. Over the course of the last several months, the A30 RQ instruments were put through a rigorous process of final verification and validation (V&V) testing. These tests were designed and conducted per the applicable guidelines and recommendations, including IEC 61010/UL 61010 for instrument safety, IEC 61326 for electromagnetic compatibility and interferences, and EN 60086 for transport, storage, and operational conditions.

The performed V&V tests included testing of mechanical and electrical safety, radiated and conducted electrical emissions and interference, mechanical robustness when exposed to mechanical shock and vibration, heat, cold, humidity, and other environmental factors. The Unyvero A30 RQ instruments were put through these tests at a number of external sites and facilities including CSA Group Europe at their German headquarter test facility, Zollner Elektronik, and ELMAC EMC/EMI test labs, and the environmental testing lab of TELUS in Germany. All test reports have now been completed. Complementing the V&V testing efforts, the Curetis team also put the Unyvero A30 RQ through a rigorous schedule of lifetime testing of all relevant mechanical instrument components, including all moving parts, cartridge loading/unloading mechanics, Peltier heaters and coolers for reaction chambers, and PCR ultrafast temperature cycling and long-term operation of the integrated hose pump. Some of these tests included tens to hundreds of thousands of repetitions to ensure that the instruments were tested well in excess of their expected lifetime usage. The PCR Peltier element as the most critical part was tested for almost 1 million PCR cycles at the highest possible ramp rates of 10 K/sec creating the most stringent stress conditions for the element. All these tests passed successfully.

Andreas Boos, CTO of OpGen’s subsidiary Curetis commented: “In my, over 30 years of engineering and platform development experience in the medical device and diagnostics industry I have never before seen a final instrument V&V program being completed with such flying colors. All findings were minor and we have been able to address all of them and mitigate them for the final series production release of the Unyvero A30 systems.” Andreas Boos added that “this effectively has also allowed us to upgrade to final product specs the ten prototype instruments that we had received in summer of 2021 and use them for further development of the platform including assay development and clinical V&V work going forward.”

Oliver Schacht, CEO of OpGen indicated that “this success in meeting this final key milestone in the Unyvero A30 instrument development now enables us to move into final product design and to get the first set of series-ready instruments built. In parallel, we expect to work on our first A30 cartridge application and look forward to bringing the platform into its first clinical trial later in 2022. Such trial data would then be aimed at future regulatory submission and clearance by the U.S. Food and Drug Administration. Having the A30 ready for clinical trials and subsequent commercialization will also be key to any partnering and licensing conversations going forward.”