FDA approves JCV test for Tysabri

FDA approved the Stratify JCV Antibody ELISA test to stratify the risk of developing progressive multifocal leukoencephalopathy (PML) in patients receiving autoimmune drug Tysabri natalizumab. The agency also approved a corresponding addition to Tysabri's label that identifies anti-JC virus antibody status as a risk factor for developing PML. FDA said the test is the first blood test approved for the indication.

The test was developed under a partnership between Quest Diagnostics Inc. (NYSE:DGX) and Tysabri's manufacturers -- Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN). Tysabri, a mAb against integrin alpha(4), is approved for multiple sclerosis (MS) and Crohn's disease. The Stratify test was previously available only as a laboratory-developed test. ...