Yes, your kit does expire. Your kit will have a minimum expiration date of 3 months. The expiration date can be found on the label on the bottom of your Auria box. Any samples that are delivered to the lab after the expiration date will not be processed, and we are unable to provide a replacement kit.
Auria is available to women in all U.S. states except New York due to regulatory requirements.
Auria is intended for women ages 30 and over. Auria is not intended for women with an unevaluated palpable mass or area of concern in their breast tissue. It is also not intended for women who no longer have breast tissue. For more information on whether you are a good candidate for Auria, visit our About Auria page.
Current data only supports biological females at birth with breast tissue. Upcoming and current clinical trials with our LGBTQIA+ community and biological males at birth is underway to expand Auria’s availability.
Auria is a lab developed test (LDT) which has been validated in Namida Lab’s high complexity Clinical Laboratory Improvement Amendments (CLIA) lab under the supervision of our Medical Director. An LDT is a test that is designed, developed, and performed within a single laboratory, regulated by the Centers for Medicare & Medicaid Services (CMS), through the Clinical Laboratory Improvement Amendments (CLIA). Currently, the FDA exercises enforcement discretion over LDTs. Certification of the laboratory is required under CLIA to ensure the validity and quality of the test.
Yes, some FSA’s and HSA’s allow for purchase of at home laboratory tests, but please check with your benefits department to be sure. To receive your "super bill" or EOB for HSA/FSA reimbursement, please contact customer service. At this time, the cost of Auria is not covered by insurance.
Yes! At the time of purchase, you'll be given the option to select the quantity of kits desired. However, if you're needing to ship kits to multiple addresses you will need to place separate orders for each address.
For bulk orders, contact us at [email protected] or call 833-MY-AURIA.
Auria has a sensitivity of 91.5% which means out of 100 women with breast cancer, Auria would classify 91.5 of those women as Medium or High (or above the diagnostic threshold); the remaining 8.5 are identified as low. Auria has a specificity of 58%, which means out of 100 normal women, Auria would classify 58 of them as Low. We have preferentially selected our algorithm to have a higher sensitivity to reduce the number of missed cancers (i.e. false negatives). As with all lab-developed tests, continued use of our assay will allow for optimization of the diagnostic parameters.
Auria can be taken at your convenience, however the test is designed to be taken prior to a screening mammogram.
Your Auria sample should be collected and shipped on the same day. Please ship your sample on Monday, Tuesday, Wednesday, or Saturday. (do not use a drop box on Saturday)
The goal of auria is to help you decide when to have a screening mammogram. Therefore, we recommend you take auria once a year prior to your screening mammogram. However, you may take auria as much as you would like, it’s up to you. If you feel a lump or have reason to worry, speak with your primary care physician.
If you are using medicated eye drops to treat an active eye infection that may affect your test results. Please wait until you have completed the full course of treatment before taking your sample for Auria.
Under Clinical Laboratory Improvement Amendments regulations, testing varies by state and requires a written or electronic request for patient testing (42 CFR 493.124). Namida Lab works with a physician network to authorize all test requisitions in every state where we offer our testing kits.
We do not have the research to support pregnant women taking Auria. Although the Schirmer strip would cause no harm, we do not know if the proteins would be elevated or not due to pregnancy.