Quest Diagnostics Introduce STRATIFY JCV™, FDA Market Authorized Blood Test
Product News Jan 23, 2012
Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted a de novo classification petition to its STRATIFY JCV™ Antibody ELISA testing service. STRATIFY JCV is the first blood test to be FDA market authorized for the qualitative detection of antibodies to the polyomavirus JC virus (JCV) for stratifying risk for progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection, in patients with multiple sclerosis (MS) receiving TYSABRI® (natalizumab), a highly effective therapy for relapsing forms of MS.
The market authorization follows FDA approval today of a product label change for TYSABRI. The new label identifies JCV antibody status as a PML risk factor; other risk factors include duration of treatment with TYSABRI and prior immunosuppressant therapy use.
STRATIFY JCV was developed under an exclusive collaboration for the United States market with Biogen Idec, co-manufacturer with Elan Corporation, plc of natalizumab. The test employs technology licensed from Biogen Idec, and is exclusively offered through Quest Diagnostics' Focus Diagnostics laboratory in the United States. It is based on a test validated and performed by Focus Diagnostics in clinical trials.
"STRATIFY JCV is a great example of the capacity of pharmaceutical and diagnostic companies to collaborate to bring important medical innovations to market," said Kathy P. Ordonez, senior vice president, discovery and development, Quest Diagnostics. "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.