Imagine testing for breast cancer in the comfort of your own home, with only a few drops of … TEARS.
That’s what a new diagnostic test, called AURIA, is purporting to do. It’s the latest in a line of at-home diagnostic testing, following in the footsteps of companies like EverlyWell, Modern Fertility, and SiPhox that offer at-home lab testing.
But Auria, created by NAMIDA Lab, has been years in the making with the potential to revolutionize breast cancer screening — and the company is in the process of creating tear biomarker screenings for additional cancers as well like colon, prostate, melanoma, and ovarian to name a few.
This is a promising technology, but we’re in the early stages (the test only became commercially available in the fall of 2022). Armed with questions, I spoke to Anna Daily, the Chief Scientific Officer of Namida Lab, who created the test and holds a Ph.D. in cell and molecular biology.
First, Here’s a Rundown of How the Test Actually Works:
Women, aged 30 or over, order a test online for $159. The kit arrives with instructions on how to collect tear samples (we’ll get to that) and send them back to the lab. Scientists analyze the tears for PROTEIN BIOMARKERS that are, according to the site, “involved in the early inflammatory process and can be elevated due to any abnormalities in your breast tissue associated with breast cancer.”
Women then receive a score — LOW, MEDIUM, HIGH — and a consult with a physician explaining what that score means and what the next steps are, depending on their age and the results.
Why At-Home Testing?
The original idea behind Auria came from Dr. Suzanne Klimberg, currently Chief of Surgical Oncology at the University of Texas Medical Branch, who was seeing breast cancer patients coming in too late, explains Daily over the phone.
“She was seeing women coming in with stage 4 breast cancer because they didn’t have access to screening care,” an issue that can occur in certain parts of the US, she says.
“We’re located in Arkansas and the access people have [to screening] state-to-state is astoundingly diverse.” Daily was the scientist brought in to bring that idea to life and subsequently created Auria.
Indeed, Auria wants to stratify that access and allow more women, who may be missing their screenings or had bad experiences, to be able to take control of their health in a safe and comfortable environment.
Speaking of Mammograms, How Does This Fit In?
To be clear, Auria is not meant to replace the mammogram and is only intended for women with average to low risk of breast cancer (i.e. not someone with a palpable mass).
The American Cancer Society recommends women aged 40 to 54 get yearly screenings while women 55 and older can screen every other year. But as Daily explains, not everyone has the ability to do that. “About 50% of women with insurance, will have yearly screenings, but women under 50, about 37% will consistently screen.”
There are many reasons women don’t screen: radiation exposure from 2-D and 3-D mammograms ( ~5 to 10 x-rays worth of radiation in millisieverts); bad or painful experiences; lack of education around screening and limited access to care.
Not only that, women under 40 have NO ACCESS to screenings for breast cancer (it’s unclear if mammograms under 40 would be beneficial for a myriad of reasons) — and Auria is looking to fill that gap.
“We used to think about breast cancer as the disease of our grandmothers and now it’s our sisters, cousins, and girlfriends,” says Daily.
Indeed, 5.6% of breast cancer cases occur in women under 40 years of age, and breast cancers diagnosed in younger women tend to be more aggressive and less responsive to treatment (via Cleveland Clinic).
Auria lets women under age 40 gain access to a test and discover what’s going on in their bodies on a molecular level.
So let’s talk about that science. What is Auria measuring and why?
The Science of Auria
Auria uses tears for a reason, they’re a biological fluid where proteins can be more easily analyzed than in blood serum. “Tears are a clean, easy fluid allowing us to get to the proteins of interest faster,” says Daily.
She and her team published a paper outlining their research in PLoS One — “Using tears as a non-invasive source for early detection of breast cancer” — back in 2022. They identified 14 possible biomarkers for breast cancer, then narrowed it down to three: S100A8, S100A9, and Galectin-3 binding protein. Their research found that proteins S100A8, and S100A9 were the best for identifying possible breast cancer.
In their research, the levels in breast cancer patients vs controls were nearly double and triple respectively. It’s this protein level, plus a woman’s age that is plugged into Auria’s algorithm, which then produces that risk score.
The identification of S100A8, S100A9 — a family of Ca2+ binding proteins — is not new. They’re known to be elevated in other cancer types as well as for other conditions.
“We have looked at these two proteins in a few other cancers with an early interest in prostate, colon, melanoma, and pancreatic,” says Daily, explaining that they have similar molecular pathways as breast cancer.
“The idea is to do [additional] tear discovery biomarker work in other cancers as well,” she says. But they launched Auria with breast cancer specifically because the evidence shows that S100A8 and S100A9 can detect breast abnormalities with a high degree of accuracy. Which is key.
In fact, Auria claims to be “92% sensitive for the detection of breast abnormalities and 54% specific.”
In other words, if 100 women with breast cancer used the test, 92 of them would be accurately identified by the test. On the flip side, if 100 women without breast cancer were tested, 54 of them would be accurately identified as negative, while 46 would be given a false-positive.
There’s always a trade-off in diagnostic testing, it’s difficult to make a test that is both highly sensitive and highly specific. That trade-off can be missing cancers or having more false positives. “We wanted to make sure we didn’t miss cancers,” says Daily.
What About Over-Diagnosis Risks?
For one, diagnosing early-stage breast cancers can be beneficial, but diagnosing Stage 0 or DCIS breast cancer — cancers that may NEVER become clinically relevant — may lead to invasive overtreatment (unnecessary double mastectomies and toxic chemotherapies). Unfortunately, there’s not always a good way to know which cancers will become clinically relevant and which will not. Recall, celebrity chef Sandra Lee famously had DCIS, but it was complications from the surgery that caused her health issues, not the potential cancer.
In fact, a new 2023 study from the Yale School of Medicine found that overdiagnosis especially happens in older women. The researchers write, “Potential overdiagnosis increased from around one in three women aged 70–74 to over half in those aged 85 and over.”
Whenever talking about cancer diagnostics we must address overdiagnosis.
That said, Auria is not designed to replace mammogram screening nor contribute to over-diagnosis. It’s designed to bring access to care to women who may not otherwise have access to screening or aren’t utilizing it. As well as fill the gap for women under 40; and as a future use, hopefully, narrow the focus of cancer screening.
Of course, there are limitations. If you do receive a high score under age 40 and need a mammogram for follow-up insurance may not cover it, despite the test score. Or your primary doctor may not even order a follow-up. The onus is on the patient to then navigate the system.
“[In addition to the physician consult], we give them a provider brochure and they can request a mammogram,” explains Daily. “Auria cannot be considered the test that would require insurance to pay for it.” At least not yet. It’s a difficult road to get payers to pay, but Auria is working on it behind the scenes.
Daily tells me they released the test direct-to-consumer because they wanted to get this information into the hands of women now, with a future goal of really focusing on women who need additional screening.
“Ideally, you could narrow the focus on sending people in [for screening] who could really use it versus screening everyone,” she says. “Then we could focus our providers on patients of concern.”
Truly, that’s what makes me excited about tests like Auria. Yes, overscreening is a problem — there will be women who get yearly mammograms for years who never receive a breast cancer diagnosis or who are treated for Stage 0 / DCIS breast cancer for no reason. Then, there are women who need follow-ups but the system is clogged because we’re screening everyone. Every woman knows OBGYNs are often booked out 3 to 9 months in advance.
Imagine being able to monitor your breast health at home, with a simple tear sample, and only having to get a mammogram if your score warranted it. That’s my personal hope for the future and hopefully, companies like Namida Labs and Auria can get us there.
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*Taryn Hillin previously worked as a journalist with a focus on lifestyle, health, and science (The Huffington Post, ABC/Univision). Her work has been cited by The New York Times, Cosmo, The Washington Post, and more. In 2019 she was diagnosed with high-grade small cell neuroendocrine cancer, Stage 3C. Armed with a 7% survival rate she not only beat cancer but now helps educate others about cancer, cancer prevention, complementary cancer treatment, and next-gen cancer technology via her sites TheAntiCancerLife on IG and TikTok.