The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies in the European Union, have issued their first Companion Diagnostic (CDx) Certificates under the In Vitro Diagnostics Regulation (IVDR). This achievement carries substantial implications for manufacturers of in vitro diagnostics (IVD) and Contract Research Organizations (CRO) such as MDx CRO. MDx is a specialized IVD CRO with expertise in conducting clinical performance studies, including companion diagnostic studies, as stakeholders adapt to the changing landscape of CDx.
Key Milestone Reached: 1st IVDR CDx Certificates Officially Issued
BSI The Netherlands (2797) issued its first CDx certificate in May, 2023, to Invivoscribe, Inc. for their LeukoStrat® CDx FLT3 Mutation Assay, a vital tool in tailoring treatment for acute myelogenous leukaemia (AML) patients with FLT3 ITD and TKD gene mutations.
Earlier, TÜV SÜD Product Service GmbH had made its mark as the issuer of the world’s first CDx certificate in accordance with the IVDR, awarded to Roche Diagnostics GmbH for a qualitative immunohistochemical cancer biomarker assay. This assay detects the programmed death-ligand 1 (PDL1) expression pattern, enabling identification of patients who will benefit most from a specific therapeutic treatment.
The milestones reached by Invivoscribe, Inc. and Roche Diagnostics GmbH signal to other manufacturers the effectiveness of the IVDR regulatory framework in certifying these devices. Furthermore, it testifies to the successful collaboration between manufacturers, EMA, and Notified Bodies, paving the way for similar certifications in the future.
Understanding the Impact of IVDR on Companion Diagnostics
Companion diagnostic devices like these are key in advancing personalized medicine, as they are clinically validated to determine patients’ likelihood of responding to a specific treatment. However, the enforcement of the IVDR has increased the regulatory oversight for these devices, pushing most into risk Class C, necessitating Notified Body review prior to being placed on the market.
The IVDR’s new risk classification concept has expanded the role of Notified Bodies like BSI and TÜV SÜD, requiring them to oversee more than 80% of IVD devices, a significant rise from the previous 10-15% under the IVD Directive. These regulatory changes underscore the value of experienced CROs like MDx CRO in supporting manufacturers through this intricate process.
Under the IVDR, CDx products, once free from Notified Body involvement, are now classified as Class C and must undergo a Notified Body conformity assessment. This process requires consultation with the European Medicines Agency (EMA) or the Competent Authority (CA) for medicinal products, as per the 2001/83/EC directive, which lengthens the overall conformity assessment process. Manufacturers must factor in this increased timeline, especially with the IVDR requiring Class C CDx products to be CE-marked by May 2026.
Choose MDx CRO for Reliable Companion Diagnostic Studies
As a trusted IVD CRO partner, MDx, with its extensive experience in managing IVD clinical performance studies including companion diagnostic studies, is equipped to assist clients through the evolving CDx and regulatory landscape. By optimizing innovative diagnostic solutions and ensuring full regulatory compliance in our CDx clinical trials, we strive to contribute to the delivery of top-tier personalized medicine, enhancing patient care worldwide.
Contact us today to learn how MDx CRO can partner with you to help bring your companion diagnostic to market.
