Alnylam Act® Primary Hyperoxaluria Type 1 (3 genes)
No-charge genetic testing of three PH-genes for individuals with suspected or family-history of primary hyperoxaluria type 1 (PH1).
Accessed through the Alnylam Act Sponsored Testing Program•Sponsored by Alnylam Pharmaceuticals•Performed by Prevention Genetics
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
The Alnylam Act program provides sponsored NGS-based testing of AGXT, GRHPR, and HOGA1 with integrated genetic counseling for patients with suspected or family-history-indicated Primary Hyperoxaluria Type 1. Testing and counseling are fully covered by the program sponsor at no cost to patients, providers, or payers, removing financial barriers to molecular confirmation, treatment planning, and cascade family screening. The test is performed by PreventionGenetics (Abbott).
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Have a family history of, or a suspected diagnosis of, primary hyperoxaluria (select at least one):
- Family history of primary hyperoxaluria
- Adult (18 years or older) with either elevated urinary oxalate or elevated plasma oxalate
- Child (under 18 years old) with at least one of the following:
- Failure to thrive and impaired kidney function
- Nephrolithiasis
- Nephrocalcinosis
- Elevated urinary oxalate or elevated plasma oxalate
- Ordered by a qualified healthcare provider
Workflow
How to use this program
- 1
Confirm Patient Eligibility
Review clinical indicators and family history to confirm eligibility and discuss testing needs.
- 2
Submit the Test Order
Place the order through the online portal or complete the test requisition form.
- 3
Collect and Label Specimen
Collect the sample and label it with two identifiers. Specimens are accepted Monday–Saturday; holiday schedules are posted in advance.
- 4
Review Test Results
PreventionGenetics returns results in about 3 weeks. Review findings with the patient or caregiver.
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 Alnylam Act PH1 genetic testing program?
The Alnylam Act program is designed for patients with a family history of primary hyperoxaluria or a suspected diagnosis of PH1 based on clinical findings. Specific eligibility criteria are defined by the program and detailed on the ordering portal. Ordering the test carries no purchase or prescribing obligation.
What genes and methodology does the Alnylam Act Primary Hyperoxaluria Type 1 panel cover?
The Alnylam Act PH1 panel uses next-generation sequencing to analyze three genes: AGXT, GRHPR, and HOGA1. This covers the primary genetic etiologies of all three types of primary hyperoxaluria, enabling molecular confirmation and subtype differentiation in a single test order.
What specimens are accepted for the Alnylam Act PH1 test, and how do I obtain a collection kit?
The Alnylam Act PH1 test accepts whole blood, saliva, or buccal swab specimens. Sample collection kits can be ordered at no charge through the PreventionGenetics ordering portal. Kits are shipped to your practice and include materials and instructions for specimen collection and return shipping.
What is the turnaround time for Alnylam Act PH1 genetic testing results?
The Alnylam Act PH1 panel has a turnaround time of 2 to 3 weeks from specimen receipt at PreventionGenetics. Results are returned to the ordering clinician, and no-cost genetic counseling is available through the program to support results interpretation and family follow-up.
Is there any cost to my practice or my patient for the Alnylam Act PH1 test?
No. The Alnylam Act program is fully sponsored. There is no charge to the patient, the ordering provider, or any payer. Testing and genetic counseling services are entirely covered by the program sponsor. There is no purchase or prescribing obligation associated with ordering.
Does the Alnylam Act program include genetic counseling for Primary Hyperoxaluria Type 1?
Yes, the Alnylam Act program provides genetic counseling at no cost as part of the testing service. Counselors can assist with results interpretation, discussion of implications for the patient and at-risk family members, and coordination of cascade screening. This support is available to both providers and patients enrolled in the program.
Which patients are eligible for Alnylam Act Primary Hyperoxaluria Type 1 genetic testing?
Patients may qualify for Alnylam Act if they meet the program's eligibility criteria:
- Patient has a family history of Primary Hyperoxaluria (PH1) or clinical suspicion of PH1.
- Adults (18+) with elevated urinary oxalate or elevated plasma oxalate.
- Children (<18) with failure to thrive and impaired kidney function.
- Children (<18) with nephrolithiasis or nephrocalcinosis.
- Children (<18) with elevated urinary or plasma oxalate.
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