Unilabs Announces First-Year Status on CE Marked STRATIFY JCV® ELISA Testing

Unilabs today announced the one-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) by identifying their anti-JC virus (JCV) antibody status. In 2011, Unilabs was selected by Biogen Idec and Elan Corporation, plc to provide STRATIFY JCV testing services for the detection of anti-JCV antibodies.

Anti-JCV antibody status is an important factor in stratifying patients at risk for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy (PML). In 2011, anti-JCV antibody status was added to the TYSABRI product label in the European Union, Switzerland, and Australia as a third risk factor to help physicians and patients with MS make more personalised treatment decisions when considering TYSABRI, a highly effective treatment for relapsing remitting forms of MS.

During this first year of operations, Unilabs has tested more than 30,000 samples from approximately 2,000 neurologists in 43 countries. With requests being received from neurologists in so many locations, STRATIFY JCV sampling materials can be ordered on Unilabs’ website in six different languages. Request and reporting forms for STRATIFY JCV have been received in 17 languages.

Yvonne Lech, Unilabs commented: “Our global centralised testing model provides pharmaceutical companies valuable information and statistics about their tests, as well as a uniform quality worldwide.”

“We’re delighted to partner with Unilabs to provide independent diagnostic services to neurologists. They have implemented a world-class service model that makes it easy and efficient to access this important serology test,” said Meena Subramanyam, Ph. D., Vice President, Translational Medicine at Biogen Idec.

Unilabs - A leader in diagnostic services

Unilabs is a leading diagnostic services company. We operate more than 100 laboratories and 30 radiology units in Belgium, Denmark, Finland, France, Italy, Norway, Portugal, Russia, Spain, Sweden, Switzerland, and the United Kingdom. Our customers are both public and private. We serve: hospitals, outpatients clinics, GPs, occupational health units, insurance companies, drug development companies and CROs. We supply medical laboratory analyses and services within clinical biochemistry, haematology, transfusion medicine, microbiology, serology, immunology, special chemistry, nuclear medicine, molecular biology, genetic testing, histopathology, and clinical trials. Our radiology units supply services within conventional X-ray, mammography, MRI, CT, ultrasound, fluoroscopy, osteoporosis, nuclear medicine and teleradiology.

For more information please visit www.unilabs.com

Contact:

Unilabs a.s.
Yvonne Lech, +45 23 44 12 84
yvonne.lech@unilabs.com