CardioNavigATTR (36 genes)
Covers the TTR gene plus 35 other cardiomyopathy genes to identify variant-associated risk for hereditary transthyretin amyloidosis (hATTR) and related cardiac conditions
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 CardioNavigATTR program, sponsored by AstraZeneca and Ionis Pharmaceuticals and performed by Prevention Genetics, provides a no-charge NGS-based 36-gene cardiomyopathy panel (including TTR) to support the diagnostic workup of hereditary transthyretin amyloidosis and related inherited cardiac conditions. The program removes the cost barrier to comprehensive genetic evaluation in the cardiology, genetics, or neurology setting, and includes genetic counseling support for patients. Ordering carries no prescribing or purchase obligation.
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 CardioNavigATTR hereditary ATTR amyloidosis testing program?
The CardioNavigATTR program is available to adult U.S. residents who meet the program's clinical eligibility criteria as specified on the test requisition form. Orders must be placed by a qualified healthcare provider in cardiology, genetics, or neurology. Specific eligibility details are outlined on the requisition, and patients who meet the program's criteria receive testing and counseling at no charge.
What does the CardioNavigATTR panel cover and what methodology is used?
The CardioNavigATTR panel is a 36-gene NGS-based hereditary cardiomyopathy panel that includes the TTR gene. It is designed to support diagnostic evaluation of suspected hereditary ATTR amyloidosis as well as broader inherited cardiomyopathy etiologies. Testing is performed by Prevention Genetics, and the panel is offered at no cost through sponsorship by AstraZeneca and Ionis Pharmaceuticals.
What specimens are accepted and what is the turnaround time for the CardioNavigATTR test?
The CardioNavigATTR program accepts whole blood, saliva, or buccal swab specimens. Sample collection kits can be ordered directly through Prevention Genetics at no charge. Turnaround time is 2 to 3 weeks from specimen receipt at the laboratory.
Is there a prescribing or purchase obligation when ordering through the CardioNavigATTR program?
There is no prescribing or purchase obligation associated with ordering the CardioNavigATTR test. The program is fully sponsored by AstraZeneca and Ionis Pharmaceuticals, and all testing and genetic counseling are provided at no cost to the patient or ordering clinician. The results are intended to support clinical decision-making without any commercial strings attached.
Does the CardioNavigATTR program provide genetic counseling support for hereditary ATTR amyloidosis results?
Yes, the CardioNavigATTR program includes genetic counseling as part of the sponsored offering. This support is available to help patients and their providers interpret results in the context of hereditary ATTR amyloidosis and broader cardiomyopathy findings. Counseling is provided at no cost through the program.
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: Adult (≥18 years) patient residing in the United States.
- Clinical criteria: Family history of hATTR, positive PYP, biopsy evidence of amyloidosis, or ≥2 red-flag symptoms raising concern 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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