Case Study:
OraLiva and the Future of Oral Cancer Diagnostics
CareQuest Innovation Partners supports OraLiva’s innovative solutions, enabling early oral cancer diagnosis and potentially life-saving interventions
Oral cancer remains one of the deadliest and most costly cancers, largely due to late-stage diagnosis. Unlike other cancers, progress in early detection and treatment has stagnated for a generation. In the US, over 58,000 people are diagnosed annually, with global cases exceeding 450,000—and incidence rates have risen steadily over the past 25 years.
Early detection, especially at the precancerous stage, leads to excellent outcomes, yet most cases are diagnosed late. Unlike cervical cancer, where the HPV/Pap test saves 85% of lives, oral cancer lacks an effective early screening tool. Often symptomless in early stages, it frequently goes unnoticed by patients and providers until it has spread.
OraLiva aims to change this – and potentially save lives – through rapid, non-invasive, Al-driven diagnostics, closing a critical gap and helping dental and medical providers diagnose and treat underserved patients earlier.
For co-founder John T. McDevitt, PhD, driving innovation in oral cancer diagnostics is deeply personal. He lost his father to lung cancer and his mother to a rare form of oral cavity cancer. This personal experience, combined with his expertise in bioengineering, smart sensors, microfluidic devices, and biomarker discovery, inspired McDevitt and his team to develop an AI-powered cytology tool. This diagnostic enables dentists to detect early signs of oral cancer—often before they are visible to the human eye. Together, these technologies empower non-expert primary care providers to deliver expert-level care through AI-enhanced clinical decision support.
“What we’ve developed at OraLiva is essentially a thermometer for oral cancer,” explains McDevitt. “Samples are taken via a non-invasive brush biopsy, then our technology reads cells and uses artificial intelligence to find cyto-signatures that tell us about the earliest signs of oral cavity lesion disease including precancer and cancer.”
Insights from SMILE Health inform market strategy, drive patient impact
OraLiva was selected for CareQuest Innovation Partners’ and MATTER’s 2024 SMILE Health accelerator. SMILE Health supports innovators who challenge norms and are ready to advance solutions that improve accessibility, equity, and the integration between oral health and overall health.
As part of SMILE, OraLiva was paired with Henry Schein as their industry partner to help refine their go-to-market strategy and reach as many patients as possible. Together they analyzed data from more than 4,700 dental practices, looking at the financial burden of oral cancer and how OraLiva’s solution could make a positive impact. OraLiva also worked with CareQuest Institute for Oral Health, analyzing data from 80,000 medical patients. Through this analysis, OraLiva estimates that their solution could reduce late–stage cancers by 85% and reduce the total cost of oral cancer care by more than 50%, a win-win-win solution for patients, providers, and insurance payers. They also found that their solution is key to supporting underserved communities: Incidence rates of oral cavity cancer are four times higher in elderly populations, and two times higher among Black Americans.
85%
estimated reduction in late-stage cancers
John T. McDevitt
Founder and Chief Scientist, OraLiva
“CareQuest Innovation Partners has been instrumental in opening up opportunities for OraLiva, helping us to solidify our value proposition and market strategy through our validation studies with CareQuest and Henry Schein. The insights we gained have accelerated our ability to deliver life-saving technology for people who need it most, and the relationships we’ve formed are long lasting and impactful.”
OraLiva and Henry Schein also interviewed key stakeholders in the healthcare industry, including periodontists, hygienists, dental support organizations, Federally Qualified Health Centers, and physicians. Key insights included finding that more than 90% of clinicians wanted a reliable diagnostic like OraLiva, and that hygienists could act as crucial patient advocates and educators in the oral cancer space, proving that success lies in engaging all members of the care team.
“At Henry Schein, we are committed to reducing health risks through innovative solutions that support the profession’s adoption of products, technologies, and services. Our goal is to improve patient care while strengthening the connection between oral health and overall health. Participating in SMILE Health and working with companies like OraLiva is a key part of this mission, aligning with our dedication to partnering with the profession to drive meaningful change and drive better outcomes for patients.”
Sara Dillon
Chief Data Officer, Henry Schein
Analyzing the needs of underserved populations with ACCELERATE
Following the success of SMILE Health, OraLiva applied for ACCELERATE, an exclusive funding opportunity for SMILE alumni. ACCELERATE builds on SMILE’s momentum, providing startups and industry partners the opportunity to work together to validate solutions that fulfill unmet needs in oral health and explore partnerships in a resource-supported environment.
Enable Dental is collaborating with OraLiva on a multi-phase pilot to integrate AI-powered oral cancer screening into Enable Dental’s mobile dental units, which largely serve seniors and adults with special needs. The first phase involves training clinical teams and developing provider materials. Later in 2025 —upon lab designation— the pilot will conduct 160 adjunctive tests to gather key data on outcomes, workflows, and revenue performance. This phased approach lays the groundwork for a scalable value-based care model, and the project overall aims to yield key insights into OraLiva’s capability to improve early detection and care for a population at high baseline risk for oral cancer.
“We’re excited about this next step in our journey as we continue working with CareQuest Innovation Partners and building on the momentum that was created during SMILE,” said McDevitt. “Enable Dental’s mission to reach underserved populations is closely aligned with our own, and we look forward to creating a new standard of care leveraging the expertise that we both bring to the table.”
OraLiva continues to gain traction, completing the equity financing for their seed round in early 2025 and also receiving $1.9 million in funding for their Direct to Phase II SBIR grant for Oral Lichenoid Lesions from the NIDCR Division of the NIH. Learn more at oraliva.com.