TESTING PROGRAM PROVIDED BY LABCORP

Elfabrio® Anti-Drug Antibody (ADA)

Elfabrio ADA testing is available to patients at no cost who are prescribed Elfabrio treatment through a testing access program between Chiesi Global Rare Disease and Labcorp.

Chiesi is offering the following tests to assist healthcare providers in monitoring immune response and adverse events:
 

505558

Elfabrio IgG w/reflex to Neutralizing Antibody

Sample type/volume: 1 mL Serum (Minimum 0.5 mL) 
Submission tube: Serum transfer tube 
Sample storage: Frozen
Collection time: Serum should be collected either immediately before drug infusion or on the same day but prior to drug infusion. 
Collection tube: Red top or gel tube

Overview

Serum is first analyzed for anti-pegunigalsidase alfa-iwxj (Elfabrio) IgG. Neutralizing antibody (nAb) testing to further characterize drug-specific IgG is only performed if Elfabrio IgG antibodies are detected. 

505642

Elfabrio IgE Antibody

Sample type/volume: 1 mL Serum (Minimum 0.5 mL)   
Submission tube: Serum transfer tube   
Sample storage: Frozen  
Collection time: Serum should be collected either immediately before drug infusion or on the same day but prior to drug infusion.   
Collection tube: Red top or gel tube

Overview

This is a qualitative test that detects anti-pegunigalsidase alfa-iwxj (Elfabrio) IgE antibody. A drug-specific IgE level does not necessarily predict or correspond to the severity of a hypersensitivity reaction. Furthermore, results should be interpreted with attention to the collection timing after infusion or prior to the subsequent infusion and should not serve as the sole basis for patient-specific clinical decision-making.

Healthcare providers should consider monitoring for the presence of IgG and IgE antibodies in patients who demonstrate hypersensitivity reactions and should consider the risks and benefits of continued treatment in patients with anti-Elfabrio IgG and IgE antibodies. 

Specimens for any of these tests should be collected just before, or on the same day before the drug infusion. ADA testing may be requested at intervals of 3, 6, 9, or 12 months based on the patient’s medical conditions and the ordering healthcare provider’s discretion. These drug-specific antibody results should not serve as the sole basis for patient-specific clinical decision-making.

*charges for venipuncture, collection fees, or other services may apply

Getting started

Getting started is easy – complete the registration form below and a program representative will be in touch to provide you with a Welcome Package and Test Request Form (TRF) to complete for your patients.

After your account is set up, you can complete a Test Request Form (TRF) for your patient and then obtain a blood sample either in your office or at a local Labcorp Patient Service Center. You will receive results through your standard Labcorp reporting method. 

Here are the approximate timelines to receive your test results 

  • IgG - 14 days (2 weeks)
  • Nab assay- 21 days (3 weeks)
  • Ig E- 7 days (1 week) 

Questions On Logistics for Testing?
 

Contact Labcorp

Questions on the program, drug, or reporting of adverse events?
Contact Chiesi at:

Phone: (888) 661-9260 
Fax: (866) 443-3092 
Email: [email protected]

Program Notice

By ordering this test and participating in the 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 understand that Chiesi will cover the cost of testing for patients who have been prescribed Elfabrio, and the testing will be performed by Labcorp. Sample collection charges may apply. You understand that Labcorp may share your information with Chiesi. You understand the eligibility criteria set forth above and have determined that the patient meets those criteria. The Patient has been informed by You that Chiesi covers the cost of the testing and the Patient understands that they are under no obligation to purchase or use any Chiesi products or services. The Patient also has been informed by You that no identifiable patient data will be shared with Chiesi as part of this program. You understand and acknowledge that (i) You will not seek reimbursement for this no-charge test from any third party, including but not limited to government healthcare programs and the Patient; (ii) You are not obligated to recommend, purchase, order, prescribe, promote or use any product or service offered by Chiesi or Labcorp; (iii) You are not obligated to participate in or to encourage patients to participate in any clinical trial or other research program conducted by Chiesi; and (iv) You will participate in the Program in accordance with applicable laws. You attest that You are authorized under applicable law to order this test and that the Patient meets the eligibility criteria.