Pfizer - nAbCyte™ Hemophilia B - Testing Program Provided by Labcorp - United States

Neutralizing Antibody Testing

The nAbCyte™ Anti-AAVRh74var HB-FE Assay (nAbCyte Assay) is indicated as a qualitative in vitro companion diagnostic device intended for the detection of neutralizing antibodies to the AAVRh74var capsid in serum specimens from patients previously diagnosed with hemophilia B to determine eligibility for treatment with the Pfizer® hemophilia B gene therapy, BEQVEZ™ (fidanacogene elaparvovec-dzkt).

Learn more about how to order testing below.

Healthcare providers can order the nAbCyte AAVRh74var HB-FE Assay (nAbCyte Assay) for eligible patients for whom they intend to prescribe BEQVEZ™ (fidanacogene elaparvovec-dzkt) using the following test number:

US 007150

Program Participation

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Step 1: Register for the Program

The nAbCyte Assay is a companion diagnostic test approved by the FDA under a Humanitarian Device Exemption Application. To order testing, the healthcare provider must complete a one-time enrollment in the program. Physicians ordering the test must obtain IRB approval for use of the nAbCyte Assay prior to requesting the test.

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Step 2: Receive Welcome Package

Once an IRB approval has been obtained, a representative from the Labcorp Program team will verify your account and provide detailed instructions for test ordering.

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Step 3: Order the Test

Complete the nAbCyte Assay specific test form (TRF) provided in your Welcome Package. Collect the specimen. Shipping instructions will be provided in your Welcome Package.

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Step 4: Receive Results

Test results will be sent to the ordering healthcare provider within approximately 7-10 days from the time the sample is received at the lab.

Current Market Availability:
This testing program is currently only available in Canada and the United States.

What is a Humanitarian Use Device (HUD)?

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.

Why is an IRB approval needed for a HUD?

FDA regulations require a standard Institutional Review Board (IRB) review when clinicians use a HUD for clinical care. IRBs are responsible for initial and continuing review of the HUD.

Collection Instructions

The nAbCyte Anti-AAVRh74var HB-FE Assay for BEQVEZ™ (fidanacogene elaparvovec-dzkt). Eligibility in moderate to severe Hemophilia B, or nAbCyte Anti-AAVRh74var HB-FE Assay, is a cell-based qualitative in vitro companion diagnostic device intended for the detection of neutralizing antibodies to the AAVRh74var capsid in serum specimens from adult patients previously diagnosed with moderate to severe hemophilia B to determine eligibility for treatment with the hemophilia B gene therapy, BEQVEZ™ (fidanacogene elaparvovec-dzkt). Patients who test positive for neutralizing antibodies to the AAVRh74var capsid are not eligible for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt). Patients who test negative for neutralizing antibodies to the AAVRh74var capsid are eligible for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt).

This diagnostic device is a single-site assay for professional use only and is to be performed only at Labcorp-Monogram Biosciences by trained and qualified laboratory personnel.

Patients must have a confirmed diagnosis of hemophilia B and conform to the drug label.

Collection tube	Red-top tube (glass or plastic clot activator, silicone-coated plastic red-top tube). Do not use gel-barrier tubes.
Sample type/volume	Serum/1 mL (preferred) 0.2 mL minimum (does not allow for repeat testing)
Submission tube	Screw-cap polypropylene transport tube. Do not use snap-cap or pop-top tubes.
Sample handling	The collection tubes should be filled and thoroughly mixed by manual inversion to mix the blood with the clotting activation agent. After mixing, allow the whole blood to clot for 30 minutes with the tube standing upright before centrifugation. Centrifuge the tube at 1500-2000 g for 15 minutes to separate the clot from serum. Transfer serum into a 1.5-2.5 mL screw-cap polypropylene transport tube within 6 hours of collection. Freeze serum at -20°C in a non-defrosting freezer. Do not flash freeze on dry ice. Do not thaw the sample after freezing.
Shipping preparation	Freeze sample prior to Labcorp courier arrival. Sample will be shipped on dry ice by Labcorp’s courier service.
Sample stability	Serum frozen at -20°C for 1 month Serum refrigerated at 4°C for 3 days Serum ambient for 20 hours

For BEQVEZ™ (fidanacogene elaparvovec-dzkt) U.S. prescribing information, click here.

Adverse events suspected to be associated with BEQVEZ™ (fidanacogene elaparvovec-dzkt) should be reported directly to Pfizer Pharmacovigilance at https://www.pfizersafetyreporting.com

Additional Information

Our dedicated Program team is available to answer your questions about the program and the process.

Have questions or concerns about the program or nAbCyte Assay? Contact Labcorp at [email protected] or call 844-294-7361.

Need to report a BEQVEZ™(fidanacogene elaparvovec-dzkt) adverse event? Contact Pfizer at: https://www.pfizersafetyreporting.com/

For further information to share with patients, download our patient handout

The nAbCyte™ AAVRh74var HB-FE Assay is FDA approved as a Humanitarian Use Device for use as a companion diagnostic in the selection of patients to receive the Pfizer hemophilia B gene therapy, BEQVEZ™ (fidanacogene elaparvovec-dzkt). The effectiveness of this device for this use has not been demonstrated.