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Updated: Sep 19, 2025

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Approach to JCV testing with natalizumab biosimilar: a UK consensus statement.

Ruth Dobson1, Tarunya Arun2, James Varley3

  • 1Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University London, UK; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, UK.

Multiple Sclerosis and Related Disorders
|June 3, 2025
PubMed
Summary
This summary is machine-generated.

JC virus (JCV) serological testing for natalizumab safety monitoring shows discordant results between the Immunowell and Stratify assays. This may lead to incorrect progressive multifocal leukoencephalopathy (PML) risk classification, impacting patient treatment access and healthcare costs.

Keywords:
BiosimilarJC virusMultiple sclerosisNatalizumabProgressive multifocal leukoencephalopathy

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Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Biosimilars offer potential cost savings and improved access to treatments like natalizumab for multiple sclerosis.
  • JC virus (JCV) serostatus testing is crucial for stratifying progressive multifocal leukoencephalopathy (PML) risk in patients on natalizumab.
  • Current risk stratification relies on the Stratify assay, but the Immunowell assay is used with the biosimilar natalizumab, Tyruko.

Purpose of the Study:

  • To evaluate the concordance of JCV serostatus results between the Immunowell and Stratify assays.
  • To assess the implications of discordant results on PML risk classification and patient management.
  • To provide guidance for managing patients with differing JCV test results.

Main Methods:

  • Comparison of JCV serostatus results obtained from the Immunowell and Stratify assays.
  • Analysis of discordant results, particularly around PML risk thresholds.
  • Evaluation of the clinical implications for patient monitoring and treatment decisions.

Main Results:

  • The Immunowell assay appears more likely to yield a positive JCV index compared to the Stratify test.
  • Negative results show high agreement between Immunowell and Stratify, supporting a rational safety strategy.
  • Discordant results pose a risk of misclassifying patients regarding PML risk.

Conclusions:

  • Inconsistent JCV testing results can lead to inappropriate PML risk assessment, potentially denying effective natalizumab therapy or causing unnecessary monitoring.
  • Guidance is needed to manage discordant results, balancing safety with patient access to treatment and minimizing healthcare burdens.
  • Harmonizing JCV testing or establishing clear protocols for discordant results is essential for optimal patient care in multiple sclerosis treatment.