Unilabs has been selected by Biogen Idec to provide a companion diagnostic anti-JCV antibody assay test, called STRATIFY-JCV. The test is a two-step ELISA assay used to detect anti-JCV antibodies. The presence of anti-JCV antibodies is one in 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).

To support customers, ordering needs and volume of samples, Unilabs and Biogen Idec have also developed a closed Web interface to 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 major languages through a multilingual call center. The project is centralized to and managed by Unilabs in Copenhagen.

Natascha Schill of Biogen Idec commented, “Unilabs is an independent commercial laboratory with a very high reputation, a strong European footprint and excellent international skills, competences and agility. We are very happy to work with Unilabs."

According to Yvonne Lech, Managing Director of Unilabs Denmark, “The experiences and the innovations created for this project can be applied in the future to create added customer value for future global companion diagnostic projects.”