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Takeda's Lysosomal Storage Disorder Anti-Drug Antibody and Biomarker (ADAB) Testing Program

Takeda's Lysosomal Storage Disorder Anti-Drug Antibody and Biomarker (ADAB) Testing Program

What is this program?

Takeda’s Lysosomal Storage Disorder Enzyme Replacement Therapy Anti-Drug Antibody and Biomarker (ADAB) Testing Program is a voluntary, free-of-charge service provided by Takeda through Labcorp to support patients receiving Takeda enzyme replacement therapies (ERTs). The program is available to healthcare providers treating Gaucher disease, Hunter syndrome/MPS II or Fabry disease patients with a Takeda ERT (VPRIV® (velaglucerase alfa), Elaprase® (idursulfase) or Replagal® (agalsidase alfa)).

Through this program, healthcare providers can request testing to detect anti-drug antibodies (ADAs) and to monitor disease-related biomarkers, supporting ongoing clinical assessment and disease management.

Who is eligible?

All patients living in the United States or internationally who are receiving or may receive treatment for Gaucher disease, Hunter syndrome/MPS II or Fabry disease with one of Takeda’s enzyme replacement therapies.

Healthcare providers treating patients in Europe and the UK should contact Takeda Lab Services at labservices@takeda.com to request support.

What testing is offered?

The program offers Anti-Drug Antibody and Biomarker testing to healthcare providers treating Gaucher disease, Hunter syndrome/MPS II, or Fabry disease patients with a Takeda ERT (VPRIV® (velaglucerase alfa), Elaprase® (idursulfase) or Replagal® (agalsidase alfa)).

Please note: Replagal® is not approved or available in the United States.

Getting started 

Getting started is easy - click the Get Started button below to begin your registration.

Following registration, you will be provided with a Welcome Package featuring additional details about the program and a Test Request Form (TRF) required to submit for patient testing.

Results will be received through the report delivery method selected at account set up.

Get in touch

For questions about program operations (including logistics)

For questions about Takeda therapeutics or testing results

Report an adverse event

Takeda's Anti-Drug Antibody and Biomarker (ADAB) Testing Program Attestation Statement

By participating in the Takeda Lysosomal Storage Disorder Anti-drug Antibody and Biomarker (ADAB) Testing Program, the healthcare provider ("You" or "Your") is responsible for ordering testing under this program in accordance with Your own medical judgment and applicable laws. You certify that you intend to prescribe or have prescribed the test-related drug for Your patient. You understand, and will inform the patient, that Takeda will cover the cost of testing under this program, and that patients and HCPs must not submit any claims to any insurance provider or government health care program for reimbursement of costs covered through the program. You understand the eligibility criteria set forth above and have determined that the patient meets those criteria. Patients and their healthcare providers ("HCPs”) are under no obligation to purchase, prescribe, order or use any Takeda or Labcorp products or services.

You understand that Labcorp may share with Takeda Your personal information and the personal health information of patients tested under the program. You are responsible for sharing with your patient the program-specific privacy notices that will be provided to you and informing them, in accordance with the program-specific privacy notice, that Labcorp may share patient health information with Takeda for assessing and reporting on the safety and effectiveness of Takeda’s enzyme replacement therapy (ERT) medications to regulatory authorities as may be required and managing risks related to these products. You are responsible for obtaining all appropriate patient consents and authorizations for processing of personal data by Takeda and Labcorp, which should include consent and authorization from non-US patients for transfer of samples and personal data to the United States for testing. For more information about how Takeda and Labcorp may process Your personal information, please review the applicable privacy notices: Website Privacy Statement | Takeda.com and Labcorp's privacy notices.