By Kristina Fiore, Staff Writer, MedPage Today
Published: January 20, 2012
SOURCE: Medical News Today
The Stratify JCV Antibody ELISA test screens for the presence of antibodies to the JC virus, a risk factor for PML in patients with multiple sclerosis or Crohn’s disease who are taking the monoclonal antibody, the agency said in a statement.
Natalizumab was pulled from the U.S. market in 2005 after the first of some 200 cases of PML came to light, but it was allowed back on the marketin 2006 after the development of a risk evaluation and mitigation strategy (REMS).
Risk of PML should be calculated not only by the antibody test results, but should also be based on the length of time the patient has been on natalizumab (more than two years increases the risk) and if the patient is taking other immunosuppresants, the FDA said.
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