The Rare Disease Specialty Testing Program provides monitoring 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.

** Please note that depending on the country, certain tests may be unavailable. For availability inquiries, please contact Labcorp at rarediseaseprogram@labcorp.com

The cost of testing and the cost of sample transport (International shipping via Marken and US transportation within the Labcorp courier system) are covered by Sanofi. If the healthcare professional or healthcare institution chooses to use a different courier, they are responsible for this cost.

Within the US, phlebotomy costs are covered when the samples are collected at a Labcorp patient service center (PSC).  

Within the US and Japan, sample collection supplies (e.g., blood collection tubes, urine collection cups, transfer tubes) are available at no cost.  

Outside of the United States and Japan, sample collection supplies are not provided and must be obtained by the health care professional or reference laboratory. This program does not cover or provide support for the cost of office visits/evaluations or other testing unrelated to this specific program. 

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.

Eligibility for biomarker testing requires patients to have a confirmed diagnosis of Pompe, Fabry, Gaucher, ASMD, or suspected of having one of the conditions or be under evaluation for potential treatment with a Sanofi product.

Labcorp offers client support to health care professionals as follows: 

Within the United States:
Labcorp client service is available Monday through Friday from 8am to 5pm US Eastern Time for blood collection supplies, courier and all non-account related inquires. Additional test request forms (TRFs) and account related inquiries should be directed to the Labcorp Program Manager at rarediseaseprogram@labcorp.com. 

Additionally, a Program Manager is available Monday through Friday between 8am and 5pm US EasternTime for account setup, account changes and issue escalation. The Labcorp Program Manager can be contacted through email at rarediseaseprogram@labcorp.com or by phone at +1-888-681-1701 (English only).

Outside of the United States:

Courier/Sample Transportation Services:
Marken, the designated courier for this program, provides logistics support through its local and regional offices in local time zones and local languages. Contact information for the local/regional Marken office is provided to health care professionals upon Labcorp account setup.
 
Testing Services:
Labcorp will offer local language support in local time zones for most program questions (e.g., Labcorp Link online portal support, result status inquiries, additional test requisition forms). Healthcare professionals are provided with the appropriate local/regional BLS (BioPharma Laboratory Services) phone number following Labcorp account setup.

At a minimum, support is available from Monday to Friday as follows:

• Japan: 8.30am to 5.30pm 
• Singapore supported time zones: 6am to 6pm 
• Latin America supported time zones: 7am to 7pm 
• Geneva supported time zones: 8am to 7pm.

Outside of the United States, to call toll-free, the appropriate toll-free access code must be dialed first and then 888-681-1701 must be dialed. Toll-free access codes can be found by visiting: https://www.business.att.com/collateral/access.html?c=0.  

The Program Manager will endeavor to respond to all inquiries within 72 hours. When an inquiry is received in a language other than English, Labcorp will utilize a translation service to respond or, if appropriate, will provide a call back in the client’s local language through its Central Laboratory Services (CLS) division.

Results are returned directly to the health care professional or reference laboratory listed on the Test Requisition Form (TRF). For adverse event tests only, (e.g., anti-drug IgE antibody, anti-drug neutralizing antibody), Labcorp also provides results to Sanofi Global Pharmacovigilance within 24 hours of test completion. If a suspected adverse event has not already been reported for the patient, Sanofi Global Pharmacovigilance Team may contact the ordering health care professional for additional adverse event related information. Sanofi does not otherwise receive identifiable result reports from Labcorp.

Yes, even though Labcorp reports adverse event test results to Sanofi Global Pharmacovigilance team, health care professionals should report all adverse events suspected to be associated with Sanofi products directly to Sanofi Global Pharmacovigilance.

• For US Reports:
Email: USPVmailbox@sanofi.com
Phone: 800-633-1610
Fax: 908-203-7783 (Deposits into USPVmailbox@sanofi.com)

• For International Reports:
Email: CL-CPV-Receipt@sanofi.com

Testing is conducted in the United States at Labcorp´s CLIA-certified, CAP-accredited laboratories. Labcorp´s Esoterix laboratory in Calabasas, California (CAP Participant No. 2298301, CLIA certificate No: 05D0663070, NY PFI 3072) and Labcorps´s Monogram laboratory in South San Francisco, California (CAP Participant No: 6909201, CLIA Certificate No: 05D0941934, NY PFI 7318).

The validation of all tests was conducted by Labcorp in compliance with CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) requirements. Furthermore, correlation studies were undertaken on immunogenicity and biomarker samples previously tested at Sanofi Clinical Specialty Laboratory (CSL).

Once samples are received at Labcorp’s laboratories in the United States, results will be available within 14 business days for routine tests and within 5 business days for adverse-event related testing. Please note that TATs do not include sample transport time. Samples collected outside of the US can take up to 14 business days for delivery to Labcorp’s laboratories for testing. 

Yes, Labcorp offers expedited testing services for all tests, subject to specific conditions. For further details on expediting your test, please contact us at rarediseaseprogram@labcorp.com.

No, although anti-drug neutralizing antibody testing is intended to further characterize a positive anti-drug IgG antibody response, a neutralizing antibody test is not performed unless the test is specifically ordered.

a. Outside the United States and Japan: Sample collection supplies are not provided. However, Labcorp will provide detailed sample collection requirements for each test following account setup. Health care professionals should ensure that samples are collected in accordance with Labcorp’s sample requirements.

b. Within the United States and Japan: Sample collection supplies (e.g., blood collection tubes, urine collection cups, transfer tubes) will be provided at no cost. Health care professionals may elect to utilize their own sample collection supplies but should ensure that samples are collected in accordance with Labcorp’s sample requirements. 

i. Within the United States, health care professionals can obtain supplies by contacting Labcorp at 1-855-LABCORP. Supplies will be delivered within 3-5 business days.

ii. Within Japan, health care professionals should contact Marken Japan to order supplies using the order form contained in their Marken starter pack. Supplies will be delivered within 3 business days.

a. Within the United States: Labcorp will provide two options for collection and delivery of samples to its testing laboratories.

i. Utilization of Labcorp’s patient service centers for sample collection and delivery.

ii. Sample collection by a health care professional with the subsequent pickup of samples. Health care professionals will be responsible for contacting Labcorp for specimen pickup at 1-855-LABCORP. Labcorp will arrange for specimen pickup within 48 hours of receipt of the request.

b. Outside of the United States: Marken is the preferred sample transportation and logistics service provider for this program and will pick up samples at the requested date and time. Following account setup, a Marken starter pack containing country-specific information about shipment procedures and corresponding documentation will be provided electronically. A hardcopy Marken starter pack will also be shipped. 

Health care professionals should refer to the Marken starter pack for complete details. The starter pack contains specific shipment procedures (e.g., pickup requests, sample packaging) and corresponding documentation (e.g., invoice, air waybill).

Health care professionals will be responsible for submitting a pickup request at least 24-48 hours in advance of pickup. At the time of pickup, Marken will provide all necessary packaging for sample transport (e.g., 95kPa transport bags, absorbent sheets, shipping box, and dry ice). Marken will batch samples from regional hubs (e.g., Singapore, Hamburg, Miami) and ship them to its testing laboratories located in the United States at least once a week. 

Samples will be delivered to Labcorp in the United States within 14 business days of pickup. 

For adverse event testing, expedited shipping is available and can be requested by health care professionals when scheduling sample pickup. Expedited shipments will bypass the batching process at regional hubs and will be shipped directly to Labcorp in the US.

Generally, samples will be delivered to Labcorp in the United States within 14 business days of pickup. For adverse event testing, expedited shipping is available but must be requested by the health care professional. From outside the United States, expedited shipping should be requested when scheduling a sample pickup by either checking off the “Adverse Event” checkbox on the Marken Booking Form or if calling to schedule sample pickup, by letting the local Marken representative know that adverse event samples are included in the shipment. 

Expedited shipments will bypass the batching process at regional Marken hubs and will be shipped directly to Labcorp in the United States.

There is no specific transfer tube requirement. A 2mL polypropylene screw cap or equivalent can be used. Healthcare professionals should ensure samples are not leaking and are properly labeled. 

Blood collection for anti-drug IgG antibody, anti-drug IgE antibody, and neutralizing antibody tests should be collected prior to infusion or at least 3 days after infusion. Blood collection for serum tryptase and complement activation tests should be collected between 1 and 3 hours after the onset of a suspected adverse event.