This information is for providers outside of the U.S. ONLY

AAV5 Total Antibody Assay for Valoctocogene Roxaparvovec Eligibility in Hemophilia A

The AAV5 DetectCDx™ for valoctocogene roxaparvovec eligibility in Hemophilia A is a qualitative in vitro diagnostic test by electrochemiluminescence intended for detection of antibodies in human plasma collected in 3.2% sodium citrate that bind to the adeno-associated virus serotype 5 (AAV5). The AAV5 DetectCDx is indicated as an aid in the selection of adult hemophilia A patients for whom valoctocogene roxaparvovec treatment is being considered. Patients that are anti-AAV5 antibody positive (result of detected) are not eligible for treatment with valoctocogene roxaparvovec; patients that are anti-AAV5 antibody negative (result of not detected) are eligible for treatment with valoctocogene roxaparvovec. This assay is for professional use only.

Instructions for Use

Select your preferred language below to download and view the AAV5 DetectCDx™ Instructions for Use

How to Order

If you are interested in ordering, please visit www.aav5detectcdx.com for more information.

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