MDx CRO presented new evidence and hands‑on learnings at ESMO 2025 that reinforce our position as the partner of choice for IVDR transitions and combined clinical trials involving investigational IVDs. We were first author on a poster with Fulgent Genetics and contributors to a Servier poster—both centered on the operational and regulatory realities of bringing high‑impact oncology diagnostics into clinical practice under the EU IVDR.
Highlights from our ESMO 2025 posters
Fulgent Genetics & MDx CRO — MDx CRO first author
Title: IVDR Compliance Challenges in Certifying a Large‑Scale NGS Panel for Hereditary Cancer
What it covers:
- Practical blueprint for transitioning a comprehensive, service‑based NGS hereditary cancer panel under IVDR.
- Defining intended use and scientific validity across a large gene set; end‑to‑end technical documentation; bioinformatics validation aligned to IEC 62304/82304; and notified‑body engagement strategy.
- Lessons on right‑sizing verification/validation and building a living evidence package to support CE‑marking.
Why it matters: Sponsors and lab developers gain an actionable path for moving complex NGS services to IVDR compliance—without slowing clinical programs.
Servier & MDx CRO (CHONQUER study) — MDx CRO contributor
Title: Navigating Regulatory Complexity in Combined Studies under CTR and IVDR (CHONQUER)
What it covers:
- How combined trials (drug + investigational IVD) trigger dual oversight under CTR and IVDR and the knock‑on effects for timelines, submissions, and site activation across EU member states.
- Operational patterns that accelerate approvals: early CPS planning, consolidated documentation, and aligned ethics/competent authority strategies.
Why it matters: Oncology sponsors can de‑risk global programs by anticipating IVDR‑specific requirements—and partnering with an IVD CRO that has worked both sides of the fence.
Key takeaways for sponsors
- IVDR transitions—end to end. MDx CRO supports dossier strategy, clinical performance studies (ISO 20916), scientific validity, and notified‑body engagement for CE‑marking.
- Combined trials, simplified. We design and run CPS and combined CTR + IVDR studies, harmonizing submissions across multi‑country portfolios.
- Oncology‑ready operations. Deep experience with molecular prescreening, NGS workflows, and drug–device coordination for precision oncology.
Need a quick debrief? Contact our IVD CRO team for a walkthrough of how these findings translate to your IVDR transition or combined study plan.
FAQs
We provide end‑to‑end support—from intended‑use definition and scientific validity to clinical performance studies, technical documentation, and notified‑body engagement.
We plan and execute CPS and combined trials, consolidating submissions and aligning ethics/competent authority requirements to reduce delays.
Yes. We design right‑sized verification/validation programs and bioinformatics validation aligned with IEC 62304/82304.
Both PDFs are available at the ESMO platform; contact us for a guided readout.
