Home·Explore by Test·nAbCyte Anti-AAVRh74var HB-FE Assay
FDA-approved companion diagnostic

nAbCyte Anti-AAVRh74var HB-FE Assay

Cell-based neutralizing antibody assay that measures functional anti-AAVrh74var activity in serum to characterize pre-existing immunity to AAVrh74-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
H230005
Supplements
Manufacturer
Labcorp
Approval date
April 25, 2024
Test specifications
Methodology
AAV Antibody
Specimen
Serum
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Serotype rh74
What this test is

The nAbCyte Anti-AAVRh74var HB-FE Assay is a cell-based neutralizing antibody test that measures functional antibodies to the AAVrh74var capsid in human serum. By quantifying inhibition of vector transduction in vitro, it reports anti-AAVrh74var nAb titers to characterize pre-existing immunity and support eligibility assessment for AAVrh74-based gene therapy.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Moderate to severe Hemophilia B patientsAAV Antibodiesserotype rh74BEQVEZ

Performing lab

Labcorp

Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at www.labcorp.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order fornAbCyte Anti-AAVRh74var HB-FE Assay 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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