FDA-approved companion diagnostic

AAV5 DetectCDx

FDA-approved immunoassay that detects anti-AAV5 antibodies in plasma to determine whether adults with hemophilia A are eligible for ROCTAVIAN gene therapy.

Lab-developed CDxMethod: AAV AntibodySpecimen: PlasmaBiomarker: Serotype 5
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P190033
Supplements
Manufacturer
ARUP Laboratories, Inc.
Approval date
June 29, 2023
Test specifications
Methodology
AAV Antibody
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Serotype 5
What this test is

AAV5 DetectCDx is a prescription-only, FDA-approved electrochemiluminescent immunoassay that qualitatively detects antibodies to adeno-associated virus serotype 5 (AAV5) in sodium-citrated plasma. It helps identify adults with severe hemophilia A who lack anti-AAV5 antibodies and are therefore eligible for ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Hemophilia A PatientsAAV Antibodiesserotype 5ROCTAVIAN

Performing lab

ARUP Laboratories, Inc.

ARUP Central Facility (46D0523979)

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah Spencer Fox Eccles School of Medicine and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit www.aruplab.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forAAV5 DetectCDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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