Test will identify treated patients at risk of developing progressive multifocal leukoencephalopathy.
Biogen Idec has selected Unilabs to provide a companion diagnostic anti-JCV antibody assay test, called Stratify-JCV. The presence of anti-JCV antibodies is part of a three-factor risk stratification algorithm, along with prior immunosuppressant use and treatment duration, used to calculate the risk of Tysabri-treated patients developing progressive multifocal leukoencephalopathy (PML).
The test is a two-step ELISA assay used to detect anti-JCV antibodies. To support customers, ordering needs, and volume of samples, Unilabs and Biogen Idec have also developed a closed web interface. This will allow neurologists to order sampling and shipping materials, register courier sample pick- up details, and request language and format of analytical reports. Also, neurologists can seek sampling, shipping, and medical support in five languages through a multilingual call center.
The project is centralized to and managed by Unilabs in Copenhagen. “Unilabs is an independent commercial laboratory with a very high reputation, a strong European footprint, and excellent international skills, competences, and agility,” comments Natascha Schill, Biogen Idec.
Unilabs says that it operates in over 100 laboratories and 30 radiology units in Europe. It serves hospitals, outpatients clinics, GPs, occupational health units, insurance companies, drug development companies, and CROs.