About Auria
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.
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 7.5 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 looks for the proteins S100A8 and S100A9. You can read more information about the science behind Auria by checking out these articles: https://namidalab.com/news/category/publication
Proteins are complex biomolecules found in your body that play a crucial role in keeping you healthy and functioning properly. Proteins are like tiny "workers" that perform various tasks, such as helping your muscles move, supporting your immune system to fight off infections, and even carrying important messages within your body among other functions. They are made up of smaller building blocks called amino acids, and different combinations of these amino acids create different proteins, each with its own specific task. They are arranged in a fashion similar to beads arranged on a string. They can be found in various foods you eat, and your body also produces its own proteins to keep everything running smoothly. In essence, proteins are essential for the proper functioning and maintenance of your body.
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)
Unfortunately, we have not been able to conduct a study looking at our markers for reoccurrence in breast cancer, so without that data is difficult to say for sure. While we did have triple negative cases in our breast cancer clinical data set we used for validating the test in our CLIA lab that were all accurately classified, the overall number was quite small and they were newly diagnosed cases not under treatment. It’s very likely long-term treatment for metastatic breast cancer could impact expression of our markers.
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. The Auria test is not affected by menstrual cycles.
No. The Auria test is not affected by birth control.
Unfortunately, we have not been able to conduct a study looking at our markers in women who were actively breast feeding. While we don’t think breast feeding would interfere with the markers, without concrete data it’s difficult to say whether the level of markers would affected.
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.