Alnylam Act® hATTR Amyloidosis
This program provides no-cost TTR gene testing for patients with signs, symptoms, or family history suggestive of hereditary ATTR amyloidosis.
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
This sponsored program offers complimentary TTR gene testing and genetic counseling for eligible patients with suspected hereditary ATTR (hATTR) amyloidosis. It enables you to confirm or rule out the diagnosis, facilitate family risk assessment, and align patient management accordingly. All services are provided at no cost to the patient, provider, or payer.
When to consider this test
Patient selection
- Patient has ≥1 high index of suspicion indicator for hereditary ATTR amyloidosis:
- Family history of hATTR
- Positive imaging consistent with amyloid (technetium, CMR, strain echo)
- Positive biopsy confirming TTR amyloid
- OR patient has ≥2 clinical indicators suggestive of hATTR:
- Sensory or motor neuropathy (neuropathic pain, altered sensation, weakness, gait issues, carpal tunnel, EMG/NCS abnormalities)
- Autonomic dysfunction (GI motility changes, orthostatic hypotension, sexual or bladder dysfunction)
- Cardiac findings (cardiomyopathy, restrictive physiology, hypertrophy, arrhythmia, conduction issues, heart failure, abnormal imaging)
- Musculoskeletal indicators (carpal tunnel history, lumbar spinal stenosis, rotator cuff injury, chronic back pain)
- Renal abnormalities (renal insufficiency or proteinuria)
- Ocular changes (vitreous opacity, glaucoma, dry eyes, retinal issues, ocular amyloid angiopathy)
Workflow
How to use this program
- 1
Confirm Eligibility
Review the patient’s history and clinical indicators to determine eligibility and discuss testing.
- 2
Order the Test
Submit the order through the online portal or complete the test requisition form.
- 3
Collect the Specimen
Collect the sample using the supplied collection tube. Label the specimen with at least two identifiers (name, DOB, or patient ID). Specimens are accepted Monday–Saturday; holiday schedules are posted one week in advance.
- 4
Receive and Review Results
PreventionGenetics processes the test and returns results to you in about 3 weeks once the sample and paperwork are received. Review results 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
What is the Alnylam Act® hATTR program?
It’s a sponsored, no-cost program enabling you to order a single-gene TTR test plus genetic counseling for patients with a suspected or known risk of hereditary ATTR (hATTR) amyloidosis.
What are the eligibility criteria for ordering this test?
Patients must be age 18 + (U.S./Canada) and either:
- Have a family history of hATTR amyloidosis, or positive imaging/biopsy for TTR amyloid
- Or have two or more clinical indicators such as neuropathy, autonomic dysfunction, heart disease, musculoskeletal signs, renal abnormalities, or ocular changes.
How do I order the test?
Use the online ordering portal or complete the program requisition form from PreventionGenetics, send the specimen (blood, saliva, or buccal swab), and follow shipping instructions.
What is the turnaround time?
Results typically are returned in about 3 weeks after the lab receives the completed specimen and paperwork.
If I identify a pathogenic variant, what about family testing?
Yes—since hATTR is inherited dominantly, a positive result in a patient should prompt consideration of cascade testing for at-risk relatives and appropriate clinical follow-up.
How are cost and billing handled?
For eligible patients, the genetic test and counseling are provided at no charge to the patient, provider or payer. Do not bill third-party payers for this sponsored testing service.
What about data privacy and sponsor involvement?
Although the program is financially sponsored by Alnylam, all services are performed by independent third-party labs and counseling providers. No identifiable patient data is provided to the sponsor; only de-identified aggregate data may be shared.
See an issue with this program?