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FDA-approved companion diagnostic

Quest Diagnostics AAVrh74 Antibody ELISA CDx

ELISA-based immunoassay that detects antibodies to AAVrh74 capsid in serum to help determine eligibility for AAVrh74 vector–based gene therapy.

Lab-developed CDxMethod: AAV AntibodySpecimen: SerumBiomarker: Serotype rh74
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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
P250002
Supplements
Manufacturer
Quest Diagnostics
Approval date
July 24, 2025
Test specifications
Methodology
AAV Antibody
Specimen
Serum
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Serotype rh74
What this test is

Quest Diagnostics AAVrh74 Antibody ELISA CDx is a prescription-use, ELISA-based companion diagnostic that qualitatively detects antibodies to the AAVrh74 capsid in human serum. By determining AAVrh74 antibody status before treatment, it helps identify patients who are seronegative or below a defined titer threshold and may be eligible for AAVrh74 vector–based gene therapy.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Duchenne Muscular Dystrophy (DMD)AAV Antibodiesserotype rh74ELEVIDYS

Performing lab

Quest Diagnostics

Marlborough, MA (22D2051942)

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forQuest Diagnostics AAVrh74 Antibody ELISA CDx 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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