FCSNext
5-gene NGS panel detecting pathogenic variants causing familial chylomicronemia syndrome (FCS) and other monogenic hypertriglyceridemia.
Accessed through the FCS Seek Sponsored Testing Program•Sponsored by Arrowhead Pharmaceuticals•Performed by Ambry Genetics
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
Sponsored, no-charge FCSNext panel for suspected monogenic hypertriglyceridemia/FCS (e.g., extreme TGs, recurrent pancreatitis, early onset, therapy-refractory). Order through Ambry; clinical report supports diagnosis, management decisions, and cascade testing of at-risk relatives.
When to consider this test
Patient selection
- Age: ≥17 years; and
- Lab: documented fasting TG >600 mg/dL (≥6.77 mmol/L) within 12 months.
- Exclusions: <17 years or previous FCS genetic testing.
Workflow
How to use this program
- 1
Order kit
Place the order (online or via TRF) per your standard workflow.
- 2
Collect & ship
Collect the patient sample, include the completed TRF, and ship per kit instructions.
- 3
Review results
You’ll be notified when results are ready; interpret and discuss with the patient.
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 Ambry Genetics, a CLIA-certified laboratory (CLIA 05D0981414). 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
Who qualifies for sponsored testing?
Patients ≥17 years with fasting TG >600 mg/dL (≥6.77 mmol/L) documented within 12 months, residing in the U.S. or Canada.
Who is excluded?
Patients <17 years or with prior genetic testing for FCS.
Which assay is used?
Ambry’s FCSNext (5-gene NGS panel for monogenic hypertriglyceridemia/FCS).
How do I order?
Use your standard Ambry workflow (online or TRF). The profile provides ordering details.
What samples are accepted?
Collect per kit instructions; specimens accepted include whole blood, Buccal swab, Saliva.
Turnaround time?
Approx. 2–3 weeks from sample receipt.
How are results delivered?
Results are released to the ordering provider; you’ll receive notification when ready.
How should I use the results?
Support diagnosis (e.g., FCS vs multifactorial HTG), inform therapy choices, and consider cascade testing for at-risk relatives.
Is insurance billed?
No; this is no-charge for eligible patients under the sponsored program.
What if a patient doesn’t meet criteria?
Consider standard billable testing through your usual channels.
See an issue with this program?