OpGen Achieves Key Development Milestone in Unyvero A30 RQ Platform Program
August 03, 2021 at 05:00 pm IST
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OpGen, Inc. announced that its subsidiary Curetis GmbH and its instrument development and engineering partner have assembled 10 final pre-series release analyzer instruments of the Unyvero A30 RQ platform. The assembly of the instruments marks the successful completion of a major development milestone in the Unyvero A30 program. The A30 RQ analyzers will now proceed into final verification and validation testing. The Unyvero A30 RQ platform is designed to deliver rapid and multiplexed testing results in a fully automated sample-to-answer manner from a wide range of native clinical specimen types. Results from simple samples such as swabs or other simple fluids could be available in under 30 minutes, and results from more complex native specimen might take between 45 to 90 minutes depending on assay specifics. The design of the A30 RQ platform has been optimized to allow for multiplexing up to 33 analytes including controls from a single native sample in a fully integrated cartridge. Given the highly flexible and versatile design of the cartridge technology the Unyvero A30 RQ can address various sample lysis requirements as well as testing for a wide range of DNA and RNA nucleic acid targets. The platform has also been designed for a competitive mix of features such as its multiplexing and rapid time to result, broad compatibility to different nucleic acid purification chemistry and optional quantitative assay formats where needed, all at favorable cost of goods for both the instrument system and the single-use cartridges. OpGen is evaluating a portfolio of potential future product development programs on the Unyvero A30 RQ platform, including rapid tests for pathogen identification for viruses, bacteria and fungi and a broad range of antimicrobial resistance or AMR marker panels. The portfolio is intended to complement the existing portfolio of highly multiplexed panels on the current Unyvero A50 platform. Furthermore, the Unyvero A30 RQ platform can be made available to third party development and commercialization partners and licensees for their own assay menu and product portfolio. The Unyvero A30 RQ platform is designed to allow straightforward migration of third party assays using well-established real time PCR technology. Discussions are ongoing at this time with several potential platform partners on various content and licensing or partnering scopes.
OpGen, Inc. (OpGen) is a precision medicine company that uses molecular diagnostics and informatics to combat infectious diseases. The Company, through its subsidiaries, is focused on developing and commercializing molecular microbiology solutions helping to guide clinicians with actionable information infections caused by multidrug-resistant microorganisms (MDROs). The Companyâs product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, next-generation sequencing (NGS) technology and AI-powered bioinformatics solutions for AMR surveillance, outbreak analysis, and antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud, as well as the Curetis CE- in vitro diagnostics (IVD)-marked polymerase chain reaction (PCR)-based severe acute respiratory syndrome (SARS)-CoV-2 test kit. The Companyâs subsidiaries include Curetis GmbH and Ares Genetics GmbH.