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Most people don’t think of it as such, but oral cancer is one of the deadliest cancers afflicting humanity. Close to 60,000 Americans are diagnosed with it annually with just over half surviving more than five years past diagnosis, a mortality rate exceeding more routinely discussed cancers. These abysmal numbers haven’t improved in years, and much of that is due to the prevalence of late-stage diagnosis for the condition. OraLiva, a cutting-edge diagnostics company co-founded by Dr. John T. McDevitt, professor of Biomaterials and Biomimetics at the NYU College of Dentistry, is working to reverse that lethal trend by pioneering the first effective early-detection tool for oral cancer.
“What we’ve developed here is basically a thermometer for oral cancer,” McDevitt says.
The diagnostic process kicks off with a non-invasive brush biopsy to collect cells from a potentially malignant oral lesion. OraLiva’s programmable and portable ‘lab-in-a-kit’ cytology platform then analyzes the sample, using AI to identify cyto-signatures indicating early signs of cancer.
“The test snaps microscopic images of these sample cells,” McDevitt explains. “The AI looks at about 200 different variables related to the size and shape of the cells and whether or not there's any specific proteins present that would be reason for concern, cross-referencing that data into a more sophisticated index we describe as the oral cancer numerical index.”
The accuracy and specificity enable non-specialist providers (for example, dentists) to supply expert-level care and targeted referrals for more specialized screening if necessary. Such early detection tends to result in far better prognoses for patients.
OraLiva’s proprietary “C-AIIDE” (Cytology Artificial Intelligence IDEntification) technology allows for these multiparameter single-cell measurements to be completed in near real-time. The database that samples are compared against was painstakingly populated via a number of NYU clinical studies that compiled detailed information on what cells look like in pre-cancerous patients, oral cavity patients, and benign patients.
Why NYU? “NYU Dentistry has the largest oral cancer center in the world, and is also the largest dental program in the world,” McDevitt says. “The institution has played a strong role in positioning us so we can move aggressively into this market and produce new testing capabilities that haven't been previously possible.”
Beyond providing resources for the latest stages of McDevitt’s research – which has spanned 15 years and three institutions – NYU also helped him shape it into a commercial venture via a fortuitous collaboration with the NYU Entrepreneurial Institute and its executive director Frank Rimalovski. This collaboration helped the team match the platform technology McDevitt had worked on for so long with the unmet need in the oral cancer market.
“The interactions with Rimalovski and his team have been off-scale good and the Tech Venture Workshop was phenomenally important for us,” McDevitt recalls. “This intensive program linked us – our team of PhD students, postdocs, faculty – into a process that facilitated our initial customer discovery, provided us with mentorship and, ultimately, with financing that allowed us to begin to focus on the gaps. The Institute’s support allowed us to go from a science project into a product and then finally into a business.”
As OraLiva advanced further down that road to monetization, McDevitt realized that communicating the journey’s specifics to a diverse customer (and provider!) base was key.
“You would think that after a decade of collaborating with some of the best oral medicine practitioners in the country, I’d know the importance of talking to the customer,” he recalls ruefully. “But that wasn’t enough to really understand what goes on in the real world. We tend to get focused on what's happening in our backyard, but the elite dental centers may treat about 5% of US-based patients and the other 95% are treated in more rural settings. The Tech Venture Workshop was super useful in terms of forcing us to get outside of our comfort zone, redo our pitch decks and learn how to really talk with and listen to stakeholders.”
The team’s next step was to secure a spot in the 2023 cohort of the National Science Foundation’s I-Corps program. “This accelerated Oraliva’s progress and facilitated a deeper discussion of customer discovery and business model validation,” says McDevitt. “Learning the Lean Launchpad methodology and receiving commercialization training gave us a stronger sense for what is required at the business end.” A big part of that process was building additional strategic relationships on the business development side to complement the science and engineering elements. “It’s all in the rolodex. It’s a superpower and one I didn’t appreciate. It was only after we filled that gap with Frank and team’s help that we could get strong interest from investors. At this point, we were great at raising NIH funding and did a decent job with commercialization grants but, as a result of the I-Corps and workshop, we had now really honed our financial model.”
Weaponizing their learnings, McDevitt and his new CEO Spencer Price (Stern ‘19) secured numerous grants through the US government’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs along with $1.6 million of funding from the NYU Innovation Venture Fund and angel investors. McDevitt adds, “I really want to emphasize that I don't think we were in a position to successfully raise equity financing until we went through the I-Corps process.”
As of this writing, OraLiva is on the verge of shipping its first batch of diagnostic tests. The team, however, refuses to rest on its laurels. Future goals include creating a testing infrastructure that will move to chair-side point-of-care and to expand detection capabilities to other epithelial cancers. But the ultimate aim is to entirely reset existing paradigms. “Where we need to go now – and it’s a large statement – is to establish a new standard of care, changing the habits of professionals who have been trained a certain way to look for oral cavity cancer,” McDevitt says. “Those past trainings are not good enough and so we're embarking on an educational process. We're working with the American Dental Association and with Delta Dental of Michigan, America's largest dental provider, to educate the community about this new testing capability.”
About the Author:
Abhimanyu 'Abhi' Das is a writer, editor, and digital curator based in New York City. He runs editorial and programming for the TEDx initiative at TED Conferences. In his off hours, he dabbles in science communication and film criticism.
