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
FCS Seek provides the FCSNext panel, a no-cost, sponsor-funded genetic test for patients with clinical features suggestive of Familial Chylomicronemia Syndrome or related monogenic hypertriglyceridemia. Sponsored by Arrowhead Pharmaceuticals and performed by Ambry Genetics, the program is designed to support definitive molecular diagnosis in patients with extreme triglyceride elevations, recurrent pancreatitis, or therapy-refractory disease. The clinical report facilitates diagnosis, management decisions, genetic counseling, and identification of at-risk relatives through cascade testing.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Patient is seventeen (17) years of age or older
- Fasting triglyceride level greater than 600 mg/dL (>6.77 mmol/L) in the past 12 months
- No prior genetic testing for FCS
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
What genes are included on the FCSNext panel for FCS and monogenic hypertriglyceridemia?
The FCSNext panel analyzes five genes associated with monogenic causes of severe hypertriglyceridemia: APOA5, APOC2, GPIHBP1, LMF1, and LPL. Testing is performed by Ambry Genetics using next-generation sequencing. The clinical report supports molecular diagnosis of Familial Chylomicronemia Syndrome, familial hypertriglyceridemia, and hyperlipoproteinemia.
Which patients are appropriate candidates for the FCS Seek sponsored genetic testing program?
FCS Seek is intended for patients with a clinical presentation consistent with monogenic hypertriglyceridemia, such as extreme triglyceride levels, recurrent acute pancreatitis, early onset of symptoms, or inadequate response to standard lipid-lowering therapy. Patients who meet the program's eligibility criteria can be tested at no cost. Refer to the program's specific eligibility requirements to confirm candidacy.
What specimen types are accepted for the FCSNext test, and how is the kit handled?
The FCSNext test accepts whole blood, buccal swab, or saliva specimens. A buccal collection kit can be shipped directly to the patient's address. The patient completes the collection at home and submits the sample directly to Ambry Genetics, minimizing the logistical burden on your practice.
What is the turnaround time for FCSNext results through the FCS Seek program?
Results are available approximately 2 to 3 weeks after Ambry Genetics receives the specimen. The ordering provider is notified when the clinical report is ready. The report is designed to support diagnosis, prognosis, management decisions, and genetic counseling, including cascade testing for at-risk family members.
Is there any cost or prescribing obligation associated with ordering through the FCS Seek program?
There is no cost to the patient or the ordering provider. Arrowhead Pharmaceuticals fully sponsors the FCSNext testing through FCS Seek. Ordering a test through this program carries no purchase or prescribing obligation of any kind.
Does the FCS Seek program provide genetic counseling support for patients tested with FCSNext?
The FCSNext clinical report from Ambry Genetics is structured to facilitate genetic counseling conversations, including variant interpretation, disease management implications, and recommendations for cascade testing of at-risk relatives. Establishing a molecular diagnosis through FCSNext is a critical step in providing accurate counseling and guiding long-term management for patients with suspected FCS.
Which patients are eligible for FCS Seek Familial Chylomicronemia Syndrome genetic testing?
Patients may qualify for FCS Seek if they meet the program's eligibility criteria:
- Age: ≥17 years
- Lab: documented fasting TG >600 mg/dL (≥6.77 mmol/L) within 12 months.
- Exclusions: <17 years or previous FCS genetic testing.
See an issue with this program?