Xpedite Diagnostics services

Contract Development and OEM Manufacturing Services

Sample preparation is our core expertise. We have developed our own set of components for addressing customer requests on specific questions in the field of RNA and DNA extraction: the SwiftX™ Toolbox. It comprises of numerous buffers, liquids, particles, solid materials, and enzymes that can be combined to rapidly develop new DNA/RNA extraction solutions dedicated to specific applications. Beyond that, we also work extensively with real-time PCR as well as numerous isothermal amplification technologies, which makes it easy for us to communicate with assay developers, who are looking for a complementing DNA/RNA extraction solution for their diagnostic assay. While you outsource the sample prep job to experts in the field, your staff can focus on their specialty - assay development. A win-win situation for mutual benefit.

IVDR Regulatory Compliance Services for Lab-Developed Tests

Xpedite Dx offers specialized regulatory services for companies developing in-vitro diagnostic (IVD) tests, focusing on compliance with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746. With the transition from the IVD Directive to the IVDR, laboratories face new challenges in achieving CE-IVD certification, particularly for lab-developed tests (LDTs) also known as In-house developed tests (IHT). Xpedite Dx provides comprehensive consulting support to ensure these tests meet regulatory requirements. Their services include reviewing technical files, strategizing regulatory approaches, conducting gap analyses of quality management systems, and performing mock and supplier audits. They aim to facilitate a seamless approval process with Notified Bodies, thus helping manufacturers avoid common pitfalls and ensuring compliance with the stringent demands of the IVDR regulation.