Auria’s success and beyond: Namida Lab’s vision for tear-based cancer screening

Fayetteville-based biotechnology company Namida Lab Inc. is developing a pipeline of cancer screening products that use tear samples as the basis for the tests.

Namida, the lab’s name, is derived from the Japanese word for tears. The company has created an award-winning, tear-based test and is building on the success of its sole commercial product as it moves on a $20 million series A fundraising round.

Auria is the first at-home biological breast cancer screening test that uses tears to detect proteins related to breast abnormalities. While not a diagnostic test, it can help women determine when to have a mammogram. Auria is for women who are at least 30 years old.

Namida Lab launched Auria in September 2022. It’s available online at auria.care and from retailers, including Amazon and Walmart.com, and healthcare website Healthyr. It’s also been made available to employees of Siloam Springs-based Simmons Foods.

Auria inventor Dr. Anna Daily is the chief scientific officer for Namida Lab. A Van Buren native, Daily earned a Bachelor of Science in biology from Arkansas Tech University in 2001 and a doctorate in cell and molecular biology from the University of Arkansas in 2008. She completed post-doctoral work in biochemistry at the UA in 2010.

The following year, Daily started researching the technology that would become Auria when she joined Ascendant Diagnostics. The company filed for a patent on the technology in 2015, which was assigned to the company in 2019. Namida Lab acquired the license to the technology in 2019. She and other employees of Ascendant Diagnostics joined Namida Lab when it was formed in 2019. Namida Lab has 23 part-time, full-time and contract workers.

EARLY RESEARCH
Daily said breast surgeon Suzanne Klimberg vetted the initial idea that led to Auria during her time at the University of Arkansas for Medical Sciences in Little Rock. Klimberg researched whether differences could be identified in the protein profiles of tear samples from women who did and did not have breast cancer.

“She … found the map, and I had to figure out the names of the roads,” Daily said. “She figured out there were protein changes, and my job was to figure out what those changes were, what the product was going to be and where it was going to fit within the continuum of care.”

From 2011 to 2019, Daily spent eight years developing the technology that became Auria. She started with Klimberg’s research, reproduced it and built on it.

“We had several different versions of what we thought the technology was going to be, how the test was going to work and where it was going to fit,” Daily said. “About 2015, we had a pretty solid idea of where it was going to be.”

The research included identifying all the proteins in a tear sample and the proteins in women who did and did not have breast cancer.

“We had to figure out which ones were different,” Daily said. “Then, we had to figure out how different they were … and were they actually related to breast cancer. Once we had that list, we had to go through and test them on a much larger dataset to see if those changes we saw in a small dataset continued to be consistent. And then write the patent. That’s the journey.”

EDISON AWARD
Earlier this year, Auria won gold at the Edison Awards. Daily attributed Auria’s success to the uniqueness of the technology in looking at tears and the need for innovation in breast cancer screening, especially in younger women.

“We’re innovating in a field that really hasn’t seen innovation in the past 20 or 30 years,” she said. “There hasn’t been a huge jump in breast cancer screening since 3D mammography started, and they’re all little incremental changes. It’s an area where women want something different desperately.”

Daily said younger women are being diagnosed with breast cancer. Conversations about women with breast cancer have shifted from those in their late 50s and 60s when she started her research in 2011 to those in their 30s and 40s. She added that the technology isn’t suitable for the younger women.

In May, the U.S. Preventive Services Task Force issued a draft recommendation showing that all women should receive breast cancer screening starting at age 40. The task force previously recommended that women in their 40s decide when to start the screening based on their health history and preferences. The change might result in 19% more lives being saved.

‘GOLD STANDARD’
Omid Moghadam, founder and CEO of Namida Lab, said mammography, an X-ray imaging technique, has been the “gold standard” of breast cancer screening since the mid-1980s, mainly because there was no other test available. However, he said one of the issues with X-ray imaging is that it doesn’t work for women with dense breasts. About half of women have dense breasts. Because of this, the imaging only serves about 50% of women. And among women who need to be screened, only half of those show up at clinics, he added. The challenges mount as the breast cancer becomes more prevalent in younger women.

“Our test can start screening at age 30 … because 30 to 82 was the age range in our clinical trials for the development of this test,” Moghadam said. “There is a need. Women in rural areas and the underserved who are not getting screened … they can use an inexpensive biological test.”

Moghadam also highlighted the many firsts of the company’s first commercial product.

“It’s the first of its kind,” he said. “It’s the first biological test for screening for breast cancer. It’s the first breast screening cancer test that can go to your house. It’s the first screening test that uses tears as the medium of testing. It’s a lot of firsts.”

FIRST INVENTION
Auria is Daily’s first but not her only invention. She’s also a co-inventor of a technology related to research on systemic juvenile idiopathic arthritis. The rare disease affects children, typically from about 1 to 2 years old, and is often identified when they stop walking because of inflamed joints.

Before COVID-19, Auria was expected to be a test administered at clinics, but Daily said COVID led Auria to become an at-home test.

“Folks are starting to want to find their own answers,” she said. “They’re frustrated with the current healthcare system (and) lack of access to care. At-home testing is a great way to take it into your own hands and get your own information. There’s a big push in functional medicine as well, which is preventative health and treating the whole human and not just treating the symptoms. They’re big proponents of at-home testing as well and make a lot of things available to their patients. The shift started with COVID. I think that’s where healthcare is going to continue to move.”

Namida Lab is developing six more tear-based tests to screen for multiple cancers, including a diagnostic test for breast cancer. She said the next most developed technology to be released would be on prostate cancer. Other cancer types the lab is researching include colon, ovarian, pancreatic and melanoma. She noted they’re all from the same cancer family, or molecular pathway, as breast cancer.

SERIES A
Moghadam said the $20 million in series A funding would be split to support the continued development, sales and marketing of Auria and the research and development of the other six products in the works.

He said Namida Lab is collaborating with Pattern Computer, a Seattle-based machine learning and artificial intelligence company, on developing the diagnostic test for breast cancer screening. While not a replacement for mammography, the new test would show whether one had breast cancer.

“You’re never going to replace imaging,” he said. “But it would give you a new paradigm for screening …  If a signal for cancer is generated, you do imaging to see where it is. You have to localize it so you can treat it. Imaging is always going to be there.”

The company spent the first nine months after Auria launched testing and developing an e-commerce marketing strategy that comprises direct-to-consumer sales. While Auria is only available online currently, the company is working to put the product on store shelves. It’s also working to provide Auria to the underserved population at a lower cost and as a test covered by insurance.

Over the past three months, the company has shipped about 1,000 tests, he said. The average price is approximately $159, equating to about $160,000 in sales.

“We’re looking at a banner year next year,” he added.

FUTURE FOCUS
Before Daily was promoted to chief scientific officer in September 2022, she was vice president of product development and innovation.

She said that in startups, roles often overlap, and that remains true for Namida Lab. Startups need certain C-level positions in a fundraising round, and tech companies need a chief scientific officer, she added.

As chief scientific officer, Daily focuses on predicting the future, looking at where healthcare, diagnostics and lab-developed tests are going. She works to determine how Namida Lab fits into this and its product pipeline. Daily works with Prashanth Ravishankar, research and development scientist for Namida Lab, to design experiments and develop its research strategy. She also spends time traveling and speaking at events.

Daily gives credit to mentor and adviser Dr. Brigitte Piniewski for the role she’s in currently. Piniewski serves as chief medical adviser for Namida Lab and works to foster next-generation biotech behavior, especially regarding the next iteration of the internet, or Web3.

“My role is to help craft messaging to fellow physicians and industry leaders as well as craft and promote this community participation,” Piniewski said. She noted that new biotech companies like Namida set themselves apart by collaborating with others to create communities striving for common goals and understanding in areas in which there was little or no knowledge available previously. “The two of them work together to mold the health intelligence of the future in very transparent ways that weren’t typical of previous companies.”