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 help patients understand the purpose of testing and what to expect.
For patients
What this test and program do
If you or a family member may be affected by hereditary transthyretin amyloidosis (hATTR), the NavigATTR program offers genetic testing of the TTR gene at absolutely no cost to you. Sponsored by AstraZeneca and Ionis Pharmaceuticals and performed by Prevention Genetics, this program is designed to help adults in the U.S. find out whether changes in the TTR gene could explain symptoms, family history, or prior test findings. Getting a clear genetic answer can be a meaningful step toward understanding your health and guiding next steps with your doctor.
Who this may help
Could this be right for you or your family?
- To qualify, all of the following must be met:
- The patient is 18 or older
- The patient lives in the United States
- The patient meets at least one of the following:
- At least one of the following:
- A family history of hereditary ATTR (hATTR) amyloidosis
- A positive cardiac nuclear scan (99mTc-PYP/DPD/HMDP uptake on bone scintigraphy) with no abnormal (monoclonal) protein in the blood or urine
- A biopsy positive 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
- Testing is ordered by a qualified healthcare provider
What to expect
How the process works
- 1
Confirm Eligibility
Talk with your health care provider to determine whether you meet the program’s eligibility criteria and whether this test is appropriate for you.
- 2
Test Ordering
Your provider will order the test using the online portal or the program’s test requisition form.
- 3
Provide a Specimen
Your provider will collect the specimen and label it with at least two identifiers. Specimens are accepted Monday–Saturday, with holiday schedules posted in advance.
- 4
Receive Your Results
PreventionGenetics processes the test and sends results to your provider in about two weeks. Your provider will review the findings, and no-cost genetic counseling is available.
Cost & coverage
Understanding potential costs
If you qualify for this program, the sponsor works with the laboratory to help make testing more affordable. Many patients pay little or no out-of-pocket cost. Your exact cost will depend on your insurance coverage and the specific criteria of the program, and the lab can explain what to expect before your sample is processed.
Quality & privacy
How your sample and information are handled
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
Common questions about this program
What is the NavigATTR genetic testing program for hereditary ATTR amyloidosis?
NavigATTR is a sponsored program that provides no-cost genetic testing of the TTR gene for adults in the United States who may be at risk for hereditary transthyretin amyloidosis (hATTR). The program is designed to help determine whether a change in the TTR gene could be connected to your symptoms, family history, or other medical findings. Testing is performed by Prevention Genetics using next-generation sequencing technology, and the program also includes genetic counseling support.
Is NavigATTR testing for hATTR really free, and who pays for it?
Yes, NavigATTR testing is completely free to you. There is no cost, no copay, and no deductible. The program is fully funded by AstraZeneca and Ionis Pharmaceuticals, who cover the entire cost of the genetic test. You will never receive a bill for the testing provided through this program.
What kind of sample is needed for the NavigATTR hereditary ATTR amyloidosis test?
The NavigATTR program accepts a whole blood sample, a saliva sample, or a buccal swab (a gentle cheek swab). Your healthcare provider will order a sample collection kit, and together you can choose the option that works best for you. The process is simple and straightforward.
How long does it take to get results from the NavigATTR hATTR genetic test?
Results from the NavigATTR program are typically available within 2 to 3 weeks after your sample reaches the laboratory. Your ordering healthcare provider will receive the results and review them with you to discuss what they mean for your health and any recommended next steps.
Is genetic counseling available through the NavigATTR program for hereditary ATTR amyloidosis?
Yes, the NavigATTR program includes genetic counseling support as part of the testing process. A genetic counselor can help you understand your results, what they mean for you and your family, and what options may be available going forward. This counseling is provided at no cost to you as part of the sponsored program.
Who can order the NavigATTR genetic test for hereditary ATTR amyloidosis?
NavigATTR testing must be ordered by a qualified healthcare provider in cardiology, genetics, or neurology. If you think you might benefit from TTR gene testing, talk to your doctor about whether the NavigATTR program could be right for you. Your provider can review the program's eligibility criteria and place the order on your behalf.
Who qualifies for NavigATTR Hereditary ATTR Amyloidosis genetic testing?
Patients may qualify for NavigATTR if they meet the program's eligibility criteria:
- Must be a U.S. resident and 18 years of age or older.
- Eligible if there is a family history of hereditary transthyretin amyloidosis (hATTR), a positive PYP scan, or a biopsy indicating amyloidosis.
- Patients with two or more red-flag symptoms suggestive of hATTR may also qualify.
- Testing must be ordered through a licensed health care professional.
Questions to ask your doctor about TTR Single-Gene Analysis
- Do you think this test is appropriate for me based on my symptoms and history?
- How could the results of this test change my diagnosis or treatment plan?
- What are the potential limitations of this test that I should understand?
- Should any of my family members also be tested based on my results?
- How will we follow up after the results are available?
Notes
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