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Quest Diagnostics STRATIFY JCV™ First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients
Date:1/20/2012

"The test has demonstrated its value as a tool that enhances PML risk assessment, and marks a significant step forward in the personalization of clinical management of MS patients who may benefit from natalizumab."

Approximately 50% to 60% of MS patients have been infected with JCV. In the general population, JCV can, in rare instances, reactivate and progress to PML, which may lead to severe neurological disability or death.

MS is an immune disorder that affects the central nervous system, can alternate between remission and relapse, and often progressively worsens over time. As many as 400,000 people have MS in the United States, and about 200 people are diagnosed each week.

About STRATIFY JCV

The STRATIFY JCV Antibody ELISA testing service provided by Focus Diagnostics is intended for the qualitative detection of antibodies to John Cunningham Virus in human serum or plasma.  The assay is intended for use in conjunction with other clinical data, in multiple sclerosis and Crohn's disease patients receiving natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only and is to be performed only at Focus Diagnostics' Reference Laboratory.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.co
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