Clinical Trials Oncology East Coast, June 30 – July 1, Boston, MA. Visit us at Booth #30.
AAIC, July 12–16, London. Connect with our experts at Booth 1205 to explore our advanced Alzheimer’s biomarker solutions, aligned with IVDR requirements.

IVDR/LDT Support for Global Clinical Trials

IVDR/LDT - Enabled Support for Global Clinical Trials
A compliant path when key biomarkers remain RUO in EU

Sponsors running global clinical trials often face a practical constraint:  biomarkers accepted in one region may remain Research Use Only (RUO) in the EU, limiting their use in clinical trial decision-making.

MLM Medical Labs provides a regulatory-aligned path forward through IVDR/LDT support for clinical research.

Read more: our alzheimer's disease use case

Health Institution Status Under IVDR

Under IVDR, only Health Institutions are permitted to develop and use LDTs for clinical research, and MLM qualifies as a Health Institution under IVDR.

This status provides the regulatory foundation for::

  • IVDR-aligned LDT validation
  • High-quality, reproducible biomarker data
  • Regulatory-compliant support for clinical trials conducted in the EU

For Sponsors, this provides clarity and confidence when navigating EU regulatory requirements in global studies.

Operating Within the IVDR Framework Today

Building on this regulatory foundation, MLM operates within the IVDR framework to support clinical research needs in the EU.

This enables MLM to:

  • Validate specific biomarker assays as LDTs under IVDR
  • Perform those tests for medical decision making in clinical trials in the EU
  • Support global trial execution without fragmenting biomarker strategies
  • Provide continuity of data across regions and trial phases

Disease-Agnostic. Trial-Focused. Regulatory-Ready.

MLM’s IVDR/LDT positioning is not limited to a single indication.

It applies broadly to global clinical trials where:

  • Biomarkers evolve faster than regulatory approvals
  • CE-marked diagnostics are not yet available
  • Trial decisions depend on fit-for-purpose assays

This includes programs across:

  • Inflammatory and autoimmune disease
  • Metabolic and cardiovascular research
  • Oncology and precision medicine
  • Neurodegenerative and rare diseases
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WHY THIS MATTERS NOW

MLM’s IVDR/LDT capability allows Sponsors to:

  • Move forward
  • Maintain global alignment
  • Reduce operational workarounds
  • Avoid unnecessary delays tied to CE-mark timelines

This approach supports practical execution within the current regulatory framework.

Let’s Discuss the Path from RUO to LDT

Reach out today to learn how MLM assesses biomarker fit-for-purpose and IVDR/LDT validation for use in EU clinical trials.

Contact US ➔