Unilabs Announces Second Year Status on CE Marked STRATIFY JCV® ELISA
COPENHAGEN, Denmark -- March 25, 2013
Unilabs announced today the two-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) who are considering
treatment with TYSABRI (natalizumab) by identifying their anti-JC virus (JCV)
Infection with JCV is required for the development of progressive multifocal
leukoencephalopathy (PML), an infrequent but serious brain infection seen in
some patients treated with TYSABRI. Anti-JCV antibody status is an important
factor in stratifying patients for the risk of developing PML. In 2011,
anti-JCV antibody status was added to the TYSABRI product label in the
European Union, Switzerland, and Australia as one of three risk factors for
developing PML. Patients who are anti-JCV antibody positive, received
treatment with TYSABRI for more than two years, and have received prior
immunosuppressant (IS) therapy have the highest risk of developing PML.
Understanding the three risk factors helps physicians and people living with
MS have more confidence in their treatment decisions when considering TYSABRI,
a highly effective treatment for relapsing forms of the disease.
STRATIFY JCV sampling materials can be ordered on Unilabs’ website in six
different languages. Request and reporting forms for STRATIFY JCV have been
provided in 17 different languages. Recently, a second generation of STRATIFY
JCV was introduced to further enhance the value of the test and implement key
Yvonne Lech, Unilabs commented: “Our centralised testing model ensures uniform
quality across regions of the analytical test that is an important
stratification tool in the decision to treat MS patients with Tysabri”.
“In our two-year partnership with Unilabs, more than 80,000 samples from
approximately 3,200 neurologists in 50 countries have been tested. This
capacity coupled with their world-class service model and multi-lingual
ordering process has helped make access to STRATIFY JCV as simple as possible
for neurologists,” 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
Yvonne Lech, Tel: +45 23 44 12 84
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