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Unilabs SA Announces Second Year Status on CE Marked STRATIFY JCV® ELISA Testing


3/25/2013 9:30:39 AM

COPENHAGEN, Denmark--(BUSINESS WIRE)--Unilabs announced today the two-year status on testing in Europe and several other markets outside Europe with the CE marked ELISA test STRATIFY JCV®. STRATIFY JCV is an important tool used to help enable individual benefit-risk assessment for patients with multiple sclerosis (MS) who are considering treatment with TYSABRI (natalizumab) by identifying their anti-JC virus (JCV) antibody status. Infection with JCV is required for the development of progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection seen in some patients treated with TYSABRI. Anti-JCV antibody status is an important factor in stratifying patients for the risk of developing PML. In 2011, anti-JCV antibody status was added to the TYSABRI product label in the European Union, Switzerland, and Australia as one of three risk factors for developing PML. Patients who are anti-JCV antibody positive, received treatment with TYSABRI for more than two years, and have received prior immunosuppressant (IS) therapy have the highest risk of developing PML. Understanding the three risk factors helps physicians and people living with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of the disease.

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