Multiplex STI PCR Test: Supporting a Smooth IVDR Journey

Challenge

As part of its growing portfolio, the client developed a fully automated multiplex real-time PCR panel capable of detecting eight common sexually transmitted infection (STI) pathogens. To bring this product to the European market, they needed to obtain CE-marking under the In Vitro Diagnostic Regulation (IVDR).

While the technical innovation was sound, the clinical performance study required for IVDR compliance presented a unique challenge. The need to collect sufficient samples for multiple low-prevalence pathogens made the study both logistically and scientifically complex. On top of that, staying within timelines was critical.

Approach

QbD Group stepped in with a hands-on and strategic approach, tailored to the client’s needs. We started by shaping a clinical performance evaluation plan that met all IVDR requirements, without overcomplicating the operational side.

Working closely with the client, we calculated a sample size that was both statistically solid and feasible in real-world conditions. We then selected study sites across the EU that provided access to the right patient populations, improving enrolment feasibility from the outset.

Result

By combining regulatory know-how with pragmatic execution, we helped the client successfully gather the clinical evidence needed for IVDR compliance. The study remained on schedule, enabling a timely CE-marking submission.

Just as importantly, the collaboration laid a strong foundation for future IVDR submissions, giving the client greater confidence moving forward.

This project not only supported the launch of an innovative diagnostic tool, but it also reinforced the client’s position as a trusted player in the European molecular diagnostics market.