CardioNavigATTR Sponsored Testing Program
Use
The CardioNavigATTR Sponsored Testing Program provides no-charge genetic testing for patients suspected of having hereditary ATTR amyloidosis. This program aims to identify genetic mutations in 48 genes related to amyloidosis, which can assist healthcare professionals in making informed decisions about patient management and risk assessment. The program is designed for adults residing in the United States who meet specific eligibility criteria, including having a family history of hATTR, positive diagnostic tests for amyloidosis, or presenting with related symptoms.
Special Instructions
Patients must reside in the United States, be at least 18 years of age, and meet specific eligibility criteria as specified on the test requisition form. All testing must be ordered by a qualified healthcare professional. The program includes no-charge genetic counseling services via telehealth provided by Genome Medical to assist patients in understanding their test results and implications.
Limitations
This test is not cleared or approved by the US Food and Drug Administration (FDA). The performance characteristics of this test were validated by PreventionGenetics LLC following CAP and CLIA regulations. As with any genetic test, there may be false positives and negatives due to limitations in the methodology or variant classification. Additionally, for saliva and buccal swab specimens, DNA contamination from microbial and food sources can impact testing accuracy and may necessitate a follow-up specimen.
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14-21 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
3 ml - 5 ml
Minimum Volume
1 ml
Container
EDTA (purple top tube) or ACD (yellow top tube)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 8 days |
| Refrigerated | 8 days |
| Frozen | 1 month |