Xpedite Diagnostics GmbH

We challenge the status quo in sample preparation and automation by striving to replace outdated, traditional products for DNA isolation and RNA extraction with cost-effective and easy-to-use kits that facilitate the rapid extraction of RNA and DNA for rapid molecular biology analysis in high-throughput laboratories as well as at the point of care.

We bring molecular technologies to the Point-of-Care by providing our customers with tools for a complete molecular analysis workflow, manual or automated. To that end, we have entered into a distribution partnership for RAA/RPA reagents, a versatile rapid isothermal amplification technology for real-time fluorescence detection, end-point detection, and lateral-flow strip detection.

We ensure regulatory compliance of IVD products using lean approaches by leveraging our deep expertise in Regulatory Affairs and Quality Management to guarantee compliance with regulatory requirements and to minimize the time-to-market for our IVD medical devices through the application of case-specific regulatory strategies.

We also offer our expertise through consulting services to other IVD companies. We help develop a lean regulatory strategy and reduce the time, effort, and costs associated with compliance with the European IVD Regulation (IVDR) 2017/746.

Visit our website for more information! www.xpedite-dx.com