About the program
This program is available for healthcare providers worldwide. Sample transportation is available for all the countries included in the North America, JAPAC, Europe and International regions. Sample supplies are only provided in the US and JAPAC regions.
Molecules
Tested molecules currently available are:
- Agalsidase beta treatment for Fabry.
- Imiglucerase treatment for Gaucher.
- Laronidase treatment for MPS I.
- Alglucosidase alfa treatment for Pompe.
- Olipudase alfa treatment for ASMD.
Geographic Scope
This program is available in the following regions: North America, JAPAC, Europe and International.
Labcorp has more than 2,000 patient service centers in the U.S.
Stakeholders
Sanofi, Labcorp, health institutions (HI), health care providers (HCP) and patients.
Immunogenicity Testing
Available tests
Anti-Drug IgG Antibody
- Alglucosidase alfa IgG Antibody (Pompe disease).
- Avalglucosidase alfa IgG Antibody (Pompe disease).
- Agalsidase beta IgG Antibody (Fabry disease).
- Imiglucerase IgG Antibody (Gaucher disease).
- Laronidase IgG Antibody (MPS I disease).
- Olipudase alfa IgG Antibody (ASMD disease).
Adverse event hypersensitivity
- Alglucosidase alfa IgE Antibody (Pompe disease).
- Avalglucosidase alfa IgE Antibody (Pompe disease).
- Agalsidase beta IgE Antibody (Fabry disease).
- Imiglucerase IgE Antibody (Gaucher disease).
- Laronidase IgE Antibody (MPS I disease).
- Olipudase alfa IgE Antibody (ASMD disease).
- Complement activation C3a for all diseases.
- Serum tryptase for all diseases.
Adverse Event Neutralizing Antibody
- Agalsidase beta rfx Neutralizing Antibody (Fabry disease).
- Laronidase rfx Neutralizing Antibody (MPS I disease).
- Alglucosidase alfa rfx Neutralizing Antibody (Pompe disease).
- Avalglucosidase alfa rfx Neutralizing Antibody (Pompe disease).
Test Eligibility
Immunogenicity testing is available to patients with Pompe, Fabry, Gaucher, MPS I and ASMD who are on treatment or being considered for treatment.
Biomarkers Testing
Available tests
- Urine glucose tetrasaccharide (urine Glc4/Hex4) for Pompe.
- Plasma globotriaosylceramide (GL-3) for Fabry.
- Plasma globotriaosylsphingosine (Lyso-GL-3) for Fabry.
- Urine globotriaosylceramide (GL-3) for Fabry.
- Plasma glucosylsphingosine (Lyso-GL-1) for Gaucher.
- Plasma lyso-sphingomyelin (lyso-SM) for ASMD.
Test Eligibility
Eligibility for biomarker testing (where permitted) are available for diagnosed patients with Pompe, Fabry, Gaucher and ASMD. Patients do not need to be on treatment to be eligible for these specific services. Baseline and monitoring purposes only. For ASMD biomarker testing: available only in countries where the drug is being commercialized.
The Sanofi Rare Disease Specialty Testing Program is not intended to and should not interfere in any way with a health care professional’s or patient’s independent judgment and freedom of choice in the treatment options for these diseases. Health care professionals and patients should always consider the full range of treatment options and select those most appropriate for the individual patient.
Health care professionals are responsible for obtaining the proper informed consent from the patient for testing. Health care professionals are responsible for ensuring that patients can exercise their data protection rights, with the assistance of Labcorp.