Quest Diagnostics Inc - DGX - reported that the FDA has granted a de novo classification petition to its STRATIFY JCV Antibody ELISA testing service. STRATIFY JCV is the first blood test to be FDA market authorized for the qualitative detection of antibodies to the polyomavirus JC virus for stratifying risk for progressive multifocal leukoencephalopathy, an infrequent but serious brain infection, in patients with multiple sclerosis receiving TYSABRI (natalizumab), a highly effective therapy for relapsing forms of multiple sclerosis. Based on exclusive collaboration with Biogen Idec, the test is only available in the United States through Quest Diagnostics’ Focus Diagnostics lab. Quest Diagnostics provides diagnostic testing, information, and services in the United States and internationally.
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