Auria is available to women in all U.S. states except New York due to regulatory requirements.
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.
The Auria test has a sensitivity of 92% which means our test will flag 92% of people who have a breast abnormality. The test has a specificity of 54% which means our test will identify people who don't have an abnormality 54% of the time. Reminder that Auria is not detecting breast cancer and is not meant as a replacement for a screening mammogram but as a supplement taken prior to your yearly screening mammogram.
Auria can be taken at your convenience, however the test is designed to be taken prior to a screening mammogram.
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.
Yes, your kit does expire. Your kit will have a minimum expiration date of 6 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.