MONTREAL, CANADA, September 24, 2026 — CellCarta announces an expansion of its regulatory options for supporting biomarker testing in clinical trials running in the European Union (EU).
Based on the recently updated “Q&A on the Belgian and European rules for in-house IVDs” by the Belgian Federal Agency for Medicines and Health Products (FAMHP), certain clinical trial activities at CellCarta may, where applicable and subject to compliance with all relevant requirements, be performed using in-house In Vitro Diagnostics (IVDs) within the scope of Article 5(5) of the IVDR. This update is relevant to CellCarta’s laboratories in Antwerp and Gosselies, spanning histopathology, genomics, immunology, and proteomics clinical research capabilities in the European Union (EU).
The updated Q&A describes that CRO laboratories established in the EU that provide consistent, state-of-the-art testing services for clinical research may use in-house IVDs provided they are intended exclusively for use in the framework of a clinical trial subject to Regulation (EU) No 536/2014.
As a result of the update, CellCarta may, under certain conditions and subject to compliance with the requirements, provide IVD clinical trial testing in the EU through an additional regulatory pathway available under Article 5(5) of the IVDR. This framework preserves the existing high-quality standards for in-house developed IVDs while reducing the time between validation and clinical sample testing.
This new option expands CellCarta’s existing service offerings for EU clinical trial testing, which includes testing with an existing CE-marked commercial assay used for its intended purpose (on-label), as well as the conduct of a Clinical Performance Study when required. For further information on the appropriate regulatory pathway of your IVD, please consult our regulatory team.
Under the availability of the regulatory pathway described in Article 5(5) of the IVDR for certain CROs, CellCarta may offer the following benefits for clinical trials in the EU:
Learn more about how this latest development can support your clinical trial in the EU.
About CellCarta
CellCarta is a global CRO providing a multiomics approach to precision medicine for all therapeutic development programs, supporting sponsors from discovery through translational, clinical, and companion diagnostics (CDx)/IVD development, with capabilities spanning histopathology, genomics, immune monitoring, proteomics, and logistics. Regulatory and quality excellence sit at the core of how CellCarta operates, backed by multiple ISO certifications, a globally harmonized quality management system, and regulatory expertise in pre-market approval and IVD regulatory standards.
Visit cellcarta.com and connect with CellCarta on LinkedIn.
Disclaimer: The views expressed in this article are CellCarta's own and should not be interpreted as having been assessed, endorsed, or validated by the FAMHP.
