Familial Chylomicronemia Panel
7-gene genetic test at no cost for individuals with suspected FCS and severe hypertriglyceridemia, helping confirm diagnosis and guide care.
Accessed through the Familial Chylomicronemia Syndrome (FCS) Sponsored Testing Program•Sponsored by Ionis Pharmaceuticals•Performed by Prevention Genetics
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
The Ionis FCS Testing Program offers a no-cost 7-gene NGS panel performed by Prevention Genetics to evaluate genetic contributors to familial chylomicronemia syndrome and related causes of persistent severe hypertriglyceridemia. Identifying a monogenic etiology in patients with refractory sHTG can meaningfully refine the diagnosis and inform management. Ionis Pharmaceuticals sponsors the program in full, and complimentary pre- and post-test genetic counseling is provided through Genome Medical. Ordering carries no prescribing or purchase obligation.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Severe refractory hypertriglyceridemia: a minimum of 2 consecutive fasting triglyceride levels at or above 880 mg/dL (or 10 mmol/L), in the absence of secondary causes or medical conditions known to cause HTG
Workflow
How to use this program
- 1
Confirm Eligibility & Discuss Testing
Evaluate whether the patient meets eligibility criteria and review the testing process. Pre-test counseling through Genome Medical is available.
- 2
Order the Test
Order using the appropriate U.S. or Canadian requisition form. Kits can be requested as needed.
- 3
Collect & Ship Specimen
Collect blood, saliva, or buccal samples. Label with two identifiers. Follow stability guidance (blood stable 48 hours at room temp; saliva/buccal at room temp). Ship Monday–Saturday.
- 4
Review Results & Offer Counseling
Results return in about 18 days. Discuss findings with the patient. Post-test counseling through Genome Medical is available.
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 Prevention Genetics, a CLIA-certified laboratory (CLIA 52D2065132) and College of American Pathologists (CAP) certified laboratory (CAP 7185561). 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 patients are appropriate for the sponsored FCS genetic testing program?
The Familial Chylomicronemia Syndrome Testing Program is intended for patients with severe refractory hypertriglyceridemia, specifically those with at least two consecutive fasting triglyceride levels greater than 880 mg/dL (10 mmol/L) in the absence of identifiable secondary causes. Patients must reside in the United States or Canada and provide informed consent. The program is designed to help differentiate monogenic FCS from multifactorial sHTG.
What genes and methodology does the Familial Chylomicronemia Syndrome panel cover?
The FCS panel evaluates 7 genes associated with familial chylomicronemia syndrome and related disorders using next-generation sequencing. The panel is performed by Prevention Genetics and is designed to identify pathogenic variants that contribute to persistent severe hypertriglyceridemia. Full gene content details are available through Prevention Genetics.
What specimens are accepted and what is the turnaround time for the FCS panel?
The Familial Chylomicronemia Syndrome panel accepts whole blood, saliva, or buccal swab (OCD-100). Sample collection kits can be ordered through Prevention Genetics. Turnaround time is 2 to 3 weeks from specimen receipt at the laboratory.
Who covers the cost of the FCS genetic testing program?
Ionis Pharmaceuticals sponsors the Familial Chylomicronemia Syndrome Testing Program in full. There is no cost to the patient and no charge to the ordering provider. The sponsorship also covers pre- and post-test genetic counseling through Genome Medical. Ordering the test carries no prescribing or purchase obligation.
Is genetic counseling available through the FCS testing program?
Yes, the Familial Chylomicronemia Syndrome Testing Program includes complimentary pre-test and post-test genetic counseling provided through Genome Medical. This support is available at no charge to the patient or the ordering clinician. Counselors can assist with result interpretation and discussion of implications for the patient and at-risk family members.
Does ordering the sponsored FCS test create any prescribing obligation?
No, ordering through the Familial Chylomicronemia Syndrome Testing Program carries no prescribing or purchase obligation of any kind. The program is sponsored by Ionis Pharmaceuticals solely to support accurate diagnosis of genetic causes of severe refractory hypertriglyceridemia. Clinicians can use the results to guide clinical decision-making independently.
Which patients are eligible for Familial Chylomicronemia Syndrome (FCS) Familial Chylomicronemia Syndrome genetic testing?
Patients may qualify for Familial Chylomicronemia Syndrome (FCS) if they meet the program's eligibility criteria:
- Patient must reside in the United States or Canada.
- Evidence of severe refractory hypertriglyceridemia (sHTG), defined as ≥2 consecutive fasting triglyceride levels > 880 mg/dL (10 mmol/L).
- No secondary causes or medical conditions known to explain sHTG.
- Patient has provided informed consent.
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