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Sponsored Testing Program

The Rare Disease Specialty Testing Program provides anti-drug IgG antibody and adverse event-related immunogenicity testing services for Pompe, Fabry, Gaucher, ASMD, and MPS I, and biomarker testing services for Pompe, Fabry, Gaucher, and ASMD.

About the Program

This program is available for healthcare providers worldwide. Sample transportation is
available across our four regions: US, Japan, Europe, and Other countries.
Sample collection supplies are only provided in the US and Japan.

Tests

Immunogenicity tests

  • Anti-Drug IgG Antibody
  • Adverse Event Hypersensitivity
  • Adverse Event Neutralizing Antibody

Biomarkers tests

  • Plasma GL-3
  • Plasma Lyso-GL-3
  • Urine GL-3
  • Plasma Lyso-GL-1
  • Urine Glc4/ Hex4
  • Plasma Lyso-SM

Geographic Scope

This program is available in the following regions: US, Japan, Europe and Other Countries

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

  • IgG Antibody (Pompe disease).
  • IgG Antibody (Fabry disease).
  • IgG Antibody (Gaucher disease).
  • IgG Antibody (MPS I disease).
  • IgG Antibody (ASMD).

Adverse event hypersensitivity

  • IgE Antibody (Pompe disease).
  • IgE Antibody (Fabry disease).
  • IgE Antibody (Gaucher disease).
  • IgE Antibody (MPS I disease).
  • IgE Antibody (ASMD).
  • Complement activation C3a for all diseases.
  • Serum tryptase for all diseases

Adverse Event Neutralizing Antibody

  • Reflex Neutralizing Antibody (Fabry disease).
  • Reflex Neutralizing Antibody (MPS I disease).
  • Reflex Neutralizing Antibody (Pompe disease).

 

 

Test Eligibility

 Eligibility for immunogenicity testing requires patients to have a confirmed diagnosis of Pompe, Fabry, Gaucher, MPS I, or ASMD, and they must be either currently receiving Sanofi product treatment or under evaluation for potential treatment with a Sanofi product.

 

Biomarker 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 biomarkers testing requires patients to have a confirmed diagnosis of Pompe, Fabry, Gaucher, or ASMD, suspected of having one of the conditions or be under evaluation for potential treatment with a Sanofi product. These tests are for baseline and monitoring purposes only.

 

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. Healthcare professionals and patients should always consider the full range of treatment options and select those most appropriate for the individual patient.

Healthcare professionals are responsible for obtaining the proper informed consent from the patient for testing. Healthcare professionals and Labcorp will work together to support patients to exercise their data protection rights.

Patients meeting eligibility criteria, as well as their treating healthcare providers, are not required to order, purchase, prescribe, and/or obtain any other product or service from Sanofi, Labcorp or any of their affiliates.

Healthcare professionals will also ensure they are not billing government or private patient insurance for these sponsored tests.