NeuroNavigATTR (66 genes)
Detects pathogenic TTR variants linked to hereditary transthyretin amyloidosis (hATTR), supporting evaluation of patients with peripheral neuropathy or autonomic symptoms
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
The NeuroNavigATTR program, sponsored by AstraZeneca and Ionis Pharmaceuticals, provides no-cost genetic testing to help differentiate hereditary transthyretin amyloidosis polyneuropathy from other hereditary and acquired neuropathies and from wild-type ATTR cardiomyopathy. Testing is performed by Prevention Genetics using NGS methodology across a 66-gene panel, making it a practical tool for resolving diagnostic ambiguity in patients presenting with peripheral neuropathy, autonomic dysfunction, or other red-flag features suggestive of hATTR. Ordering the test carries no prescribing or purchase obligation of any kind.
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 hATTR genetic testing program?
The NeuroNavigATTR program is available to adult U.S. residents where hereditary ATTR amyloidosis is part of the differential diagnosis. Eligible patients include those with a family history of hATTR, a positive PYP scan, a biopsy positive for amyloidosis, or two or more red-flag symptoms. Orders must be placed by a qualified provider in cardiology, genetics, or neurology. Specific eligibility criteria are detailed on the test requisition form.
What does the NeuroNavigATTR panel cover and what methodology is used?
The NeuroNavigATTR panel interrogates 66 genes, including TTR, using next-generation sequencing. The panel is designed to distinguish hATTR polyneuropathy from phenocopies, including other hereditary and acquired neuropathies. Testing is performed by Prevention Genetics, and results are delivered directly to the ordering clinician.
What specimens are accepted and what is the turnaround time for the NeuroNavigATTR test?
The NeuroNavigATTR test accepts whole blood, saliva, or buccal swab (OCD-100) specimens. Sample collection kits are shipped to the ordering provider's practice at no charge. Turnaround time from specimen receipt is 2 to 3 weeks.
Is there any cost or prescribing obligation when ordering the NavigATTR hATTR genetic test?
There is no cost to the patient or the ordering practice. The NavigATTR program is fully funded by AstraZeneca and Ionis Pharmaceuticals, and testing, collection kits, and genetic counseling support are all provided at no charge. Ordering the NeuroNavigATTR test carries absolutely no purchase or prescribing obligation.
Does the NavigATTR program include genetic counseling support for hATTR test results?
Yes, the NavigATTR program includes genetic counseling as part of the sponsored service at no additional cost. Counseling support is available to help patients understand their results and next steps, which can be particularly valuable in cases where a TTR variant of uncertain significance is identified or when cascade testing for family members is being considered.
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 evidence of amyloidosis, or ≥2 red-flag symptoms concerning for hATTR.
- Ordering requirements: Testing must be ordered by a qualified health care provider in accordance with program requisition requirements.
See an issue with this program?