TTR Single-Gene Analysis
Detects pathogenic variants in the TTR gene associated with hereditary transthyretin amyloidosis (hATTR), supporting diagnosis and evaluation of hereditary risk.
Accessed through the NavigATTR Sponsored Testing Program•Sponsored by AstraZeneca, Ionis Pharmaceuticals•Performed by Prevention Genetics
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
NavigATTR provides no-cost TTR single-gene analysis by next-generation sequencing for adult U.S. patients with clinical suspicion for hereditary transthyretin amyloidosis. Funded by AstraZeneca and Ionis Pharmaceuticals and performed by Prevention Genetics, the program supports diagnostic evaluation and risk stratification in patients where hATTR is in the differential, helping move from clinical suspicion to a definitive genetic answer without adding cost barriers for the patient or practice.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Adult (18 years of age or older)
- Resides in the United States
- Meets at least one of the following:
- At least one of the following:
- Family history of hereditary ATTR amyloidosis
- Myocardial radiotracer (99mTc-PYP/DPD/HMDP) uptake on bone scintigraphy and the absence of a monoclonal protein in serum or urine
- Positive biopsy for amyloidosis
- At least one symptom from two separate categories below:
- Autonomic dysfunction
- Bladder dysfunction
- Early satiety
- Erectile dysfunction
- Orthostatic hypotension
- Bilateral carpal tunnel syndrome
- Gastrointestinal
- Nausea and vomiting
- Alternating bouts of diarrhea/constipation
- Heart disease
- Arrhythmias
- Heart failure or cardiomyopathy
- Edema
- Fatigue
- Shortness of breath
- Lumbar spinal stenosis
- Motor dysfunction
- Difficulty walking
- Impaired balance
- Muscle weakness
- Neurological disease
- Numbness and tingling in feet and/or hands
- Pain in extremities
- Sensitivity to pain and temperature
- Renal issues
- Proteinuria
- Renal insufficiency/failure
- Ordered by a qualified healthcare provider
Workflow
How to use this program
- 1
Assess Patient Eligibility
Confirm that the patient meets program criteria and review the purpose and scope of testing before proceeding with the requisition or portal order.
- 2
Order the Test
Place the order through the online portal or requisition form and ensure all required patient and clinical information is included for processing.
- 3
Collect and Label Specimen
Collect the specimen using the appropriate tube and label with two identifiers. Specimens are accepted Monday–Saturday, with posted holiday exceptions.
- 4
Review and Discuss Results
Results are typically available in about two weeks. Discuss findings with the patient and caregiver as appropriate. Genetic counseling support is available for both providers and patients.
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 NavigATTR sponsored TTR genetic testing program?
NavigATTR is available to adult patients (18 years and older) residing in the United States who meet the program's clinical eligibility criteria as specified on the test requisition form. Ordering is limited to qualified healthcare providers in cardiology, genetics, or neurology. Full eligibility details are available on the requisition, and the program team can assist with any questions about patient appropriateness.
What does the NavigATTR test cover and what methodology is used?
The NavigATTR program provides TTR single-gene analysis using next-generation sequencing (NGS). Testing is performed by Prevention Genetics (a wholly owned subsidiary of Abbott) under CAP and CLIA standards. The analysis is focused on identifying pathogenic and likely pathogenic variants in the TTR gene to support diagnostic evaluation and clinical decision-making in suspected hereditary transthyretin amyloidosis.
What specimens are accepted and how do I obtain collection kits for NavigATTR testing?
NavigATTR accepts whole blood, saliva, or buccal swab (OCD-100) specimens. Sample collection kits can be ordered directly through the Prevention Genetics ordering portal. Kits are shipped to your practice, and completed specimens are returned to the lab using the provided materials.
What is the turnaround time for NavigATTR TTR gene testing results?
Results from the NavigATTR program are typically returned within 2 to 3 weeks from specimen receipt at Prevention Genetics. Reports are delivered to the ordering clinician and include variant classification to support clinical interpretation and next steps in patient management.
Is genetic counseling included with the NavigATTR hATTR testing program?
Yes, the NavigATTR program includes genetic counseling support as part of the sponsored offering. This resource is available at no cost to the patient and can assist with pre-test education, results interpretation, and family implications. Counseling support can be a valuable complement to your clinical workflow, particularly for patients new to genetic testing.
Is there any prescribing or purchase obligation when ordering through the NavigATTR program?
There is no prescribing or purchase obligation associated with ordering through NavigATTR. The program is fully funded by AstraZeneca and Ionis Pharmaceuticals, and testing is provided at no cost to the patient or the ordering practice. The goal is to facilitate timely genetic evaluation for patients with suspected hATTR, independent of any treatment decisions.
Which patients are eligible for NavigATTR Hereditary ATTR Amyloidosis genetic testing?
Patients may qualify for NavigATTR if they meet the program's eligibility criteria:
- Age and residency: Patient is an adult (≥18 years) and resides in the United States.
- Clinical criteria: Patient has a family history of hATTR, positive PYP, biopsy consistent with amyloidosis, or ≥2 red-flag symptoms concerning for hATTR.
- Ordering requirements: Testing must be ordered by a qualified health care professional in accordance with the program’s requisition form.
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