Ipsen-Sponsored Cholestasis Panel (PEDS)
Comprehensive analysis of 110 genes associated with PFIC, ALGS, and other cholestatic liver diseases to support diagnosis, guide management, and inform family risk.
Accessed through the Cholestasis Genetic Testing Sponsored Testing Program•Sponsored by Ipsen•Performed by Invitae | Labcorp
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
The Ipsen-Sponsored Cholestasis Genetic Testing Program provides a no-cost 110-gene NGS panel for pediatric patients in the US with suspected inherited cholestatic liver disease, including PFIC and Alagille syndrome. Ipsen fully sponsors the testing, eliminating cost as a barrier and enabling earlier molecular characterization of cholestatic phenotypes. Post-test genetic counseling is included, and ordering carries no prescribing or purchase obligation.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Resident of the United States
- Patient has NOT been diagnosed with an extrahepatic disorder (e.g., biliary atresia or TNP cholestasis)
- Patient is being evaluated for a possible diagnosis of Progressive Familial Intrahepatic Cholestasis (PFIC) or Alagille syndrome (ALGS)
- Select the single most appropriate status:
- Currently cholestatic, or has a history of cholestasis, with an unclear diagnosis or without a diagnosis of an extrahepatic disorder (e.g., biliary atresia)
- Presents with an unexplained chronic liver disease (i.e., jaundice or changes in liver function tests)
Workflow
How to use this program
- 1
Order Test
Confirm eligibility, obtain consent, and place the order through the Invitae portal.
- 2
Collect Sample
Use an Invitae kit for specimen collection. Ship at no cost using the included return label.
- 3
Review Results
View results online and use available tools to support patient counseling and care decisions.
Billing overview
Program billing
For eligible patients, the sponsor has arrangements with the laboratory that may reduce or cover some or all of the patient's out-of-pocket cost. Actual cost and patient responsibility vary by program criteria. Refer to lab or sponsor materials for details.
Quality & privacy
Laboratory quality & data handling
Testing is performed by Invitae | Labcorp, a CLIA-certified laboratory (CLIA 05D2040778). Your sample is processed using validated methods and quality controls to support reliable genetic results.
Your health information is handled under privacy and security practices that are intended to align with applicable regulations. For program- and lab-specific details, review the privacy information provided by the laboratory and sponsor.
FAQ
Frequently asked questions
Which pediatric patients are appropriate for the Ipsen-Sponsored Cholestasis Panel?
The Ipsen-Sponsored Cholestasis Panel is designed for pediatric patients in the US with clinical suspicion of an inherited cholestatic liver disease, including PFIC and Alagille syndrome. The 110-gene panel covers ABCB4 and other genes associated with cholestatic disorders. Clinicians should confirm their patients meet the program's eligibility criteria before ordering.
What does the Ipsen Pediatric Cholestasis Panel test and what methodology is used?
The Ipsen Pediatric Cholestasis Panel evaluates 110 genes associated with inherited cholestatic liver diseases, including ABCB4, using next-generation sequencing (NGS). Testing is performed by Invitae at Labcorp. The panel is designed to provide actionable molecular data to aid in confirming a cholestatic diagnosis and informing management decisions.
What specimen types are accepted for the Ipsen Cholestasis Genetic Testing Program?
The Ipsen-Sponsored Cholestasis Genetic Testing Program accepts whole blood, saliva, or buccal swab specimens. Collection kits can be requested through the program. This flexibility in specimen type is particularly useful for pediatric patients where phlebotomy may be challenging.
What is the turnaround time for the Ipsen-Sponsored Cholestasis Panel?
The Ipsen-Sponsored Cholestasis Panel typically returns results within 10 to 21 days from specimen receipt. Reports are delivered to the ordering clinician. Complimentary post-test genetic counseling is available for patients and families through the program.
Is there any cost or prescribing obligation when ordering the Ipsen Cholestasis Panel?
There is no cost to the patient or ordering clinician for the Ipsen-Sponsored Cholestasis Genetic Testing Program. Ipsen fully sponsors the testing and the included post-test genetic counseling. Ordering through this program carries no purchase or prescribing obligation of any kind.
Is post-test genetic counseling available through the Ipsen Cholestasis Genetic Testing Program?
Yes, the Ipsen-Sponsored Cholestasis Genetic Testing Program includes complimentary post-test genetic counseling for patients and families. This service is fully covered by the program sponsor, Ipsen, and is available after results are reported. It can supplement your own counseling discussions and assist families in understanding molecular findings and their clinical implications.
Which patients are eligible for Cholestasis Genetic Testing Cholestasis genetic testing?
Patients may qualify for Cholestasis Genetic Testing if they meet the program's eligibility criteria:
- Patient resides in the United States
- No known extrahepatic disorder explaining cholestasis (e.g., biliary atresia)
- And one of the following applies:
- Current or past cholestasis with no identified cause
- Unexplained chronic liver disease, including jaundice or persistent liver test abnormalities
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