AAV5 DetectCDx U.S.

ARUP is the only laboratory that offers the FDA-approved CDx for ROCTAVIAN.

We are a CAP-, ISO 15189-, and CLIA-certified reference lab with more than 35 years of experience supporting laboratories, physicians, and patients with unparalleled quality and service.

AAV5 DetectCDx™ is offered at no cost to evaluate eligibility for an FDA-approved indication. While the assay is provided at no cost, shipping supplies and any other expenses, charges, services, costs, materials, or lab work that are not provided by ARUP are not covered under this program.⁶

No patient, private health plan, government health program, or any other individual or entity shall be billed for this serotype test, and no reimbursement will be sought for any tests or materials provided at no cost in connection with such test. Access to the test at no cost is not contingent upon the recommendation, ordering, prescription, or purchase of any other product or service.

How to Order

Collection Instructions

	Collect patient’s whole blood in a 3.2% sodium citrate tube.
	Centrifuge blood to separate plasma from cells within 72 hours of collection. Refer to your manufacturer’s manual for recommended centrifuge speed and duration.
	Transfer 1 mL (minimum: 0.5 mL) of plasma into a pour-off (transport) tube. Insufficient volume may result in the need for patient redraw.
	Freeze plasma specimen at -10°C or below
	Ship frozen plasma specimens to ARUP as soon as possible.

Note: Plasma specimens must be completely frozen prior to shipment to ARUP Laboratories

Visit aruplab.com/AAV5 for more detailed collection and shipping instructions. Please contact ARUP Laboratories Client Services via phone (1-800-522-2787), email (clientservices@aruplab.com), or Live Chat for more information.

Notes:

• Samples must not exceed 7.3% sodium citrate, as higher concentrations cannot be evaluated.
• Specimens that do not contain enough plasma may not be tested.
• When drawing blood for the AAV5 DetectCDx test, universal precautions for bloodborne pathogens should be observed.
• Plasma specimens must be frozen before they are shipped to ARUP Laboratories.

Instructions for Use

For complete instructions, download the AAV5 DetectCDx™ Instructions for Use.

Physician and Patient Support Program

BioMarin RareConnections™ program provides a wide array of support services for patients and physicians throughout the treatment journey.

These services include:

• Assisting patients with insurance benefit investigation and providing physicians with education about prior authorization requirements
• Providing financial assistance options for eligible patients
• Coordinating product delivery to the treatment site
• Acting as an educational resource for you, the ordering physician, and your patients
• Providing laboratory location and logistics assistance for required eligibility and postinfusion monitoring

To enroll in BioMarin RareConnections™, you will need your patient to complete a patient consent form. Once complete, a dedicated BioMarin RareConnections™ team will be able to support you, the ordering physician, and your patient throughout the treatment journey.

Additional Resources

Physician website

BioMarin RareConnections website – U.S. only

BioMarin Global Medical Information

References

1. Intended Use: The AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A (“AAV5 TAb Assay”) or AAV5 DetectCDx 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 TAb Assay is indicated as an aid in the selection of adult hemophilia A patients for whom ROCTAVIAN treatment is being considered. Patients that are anti-AAV5 antibody positive (result of Detected) are not eligible for treatment with ROCTAVIAN; patients that are anti-AAV5 antibody negative (result of Not Detected) are eligible for treatment with ROCTAVIAN. This assay is for professional use and is a single-site assay performed at ARUP Laboratories.
2. For more detailed information about ROCTAVIAN and its safety and efficacy, please go to www.roctavian.com/hcp
3. Contraindications: None
4. Warnings and Precautions

• When drawing blood for the AAV5 TAb Assay or AAV5 DetectCDx, universal precautions for bloodborne pathogens should be observed.
• Stability of the patient sample during processing has been established for 72 h at room temperature and 72 h refrigerated (2°C to 8°C) in the AAV5 TAb Assay or AAV5 DetectCDx.
• Interfering substances in the AAV5 DetectCDx include: hemoglobin >800 mg/dL, triglycerides >500 mg/dL, rheumatoid factor >476 IU/mL.
• Collected patient samples must not have greater than 7.3% sodium citrate.
• Patients with a Not Detected result may receive ROCTAVIAN infusion.

5. This test can only be conducted on plasma from adult male patients collected in 3.2% sodium citrate anticoagulant. Other specimen types and conditions have not been validated.
6. Enrollment and eligibility requirements may apply, and BioMarin reserves the right to terminate or end this program at any time.