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
This sponsored program provides no-cost genetic testing for adult U.S. patients with a family history of hATTR, positive PYP or biopsy findings, or red-flag symptoms concerning for hATTR. Testing includes TTR gene analysis to support diagnostic evaluation, risk assessment, and clinical decision-making in patients with suspected hereditary transthyretin amyloidosis.
When to consider this test
Patient selection
- 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.
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 may qualify for this program?
Eligible patients are adult (≥18 years) U.S. residents with either a family history of hATTR, positive PYP scan, biopsy consistent with amyloidosis, or two or more red-flag symptoms raising concern for hATTR.
What does the program include?
The program covers no-cost genetic testing that includes analysis of the TTR gene. Pre-test and post-test genetic counseling is available at no cost through a third-party service.
How do I order testing?
You may order through the program’s online portal or by using the test requisition form. Required clinical and patient information must be completed before processing.
What specimens are accepted?
Specimens must be collected using the appropriate collection tube and labeled with at least two patient identifiers. Deliveries are accepted Monday–Saturday; holiday schedules are posted in advance.
How long does testing take?
Results are typically available within about two weeks of specimen and paperwork receipt.
Is genetic counseling available for my patients?
Yes. Genome Medical, a national telehealth genetics provider, offers no-cost pre-test or post-test genetic counseling for patients through this sponsored program. Counseling is delivered by telephone to help patients understand testing, ask questions, and review results. You may refer a patient for one pre-test or one post-test session by checking the appropriate boxes in the genetic counseling section of the test requisition form.
How should I discuss results with patients?
Discuss findings in the context of the clinical presentation, family history, and any red-flag symptoms. Genetic counseling is available to support both providers and patients as needed.
See an issue with this program?