NSF Org:	TI Translational Impacts
Recipient:	ORALIVA, INC.
Initial Amendment Date:	February 13, 2023
Latest Amendment Date:	February 13, 2023
Award Number:	2233372
Award Instrument:	Standard Grant
Program Manager:	Henry Ahn hahn@nsf.gov  (703)292-7069 TI  Translational Impacts TIP  Directorate for Technology, Innovation, and Partnerships
Start Date:	February 15, 2023
End Date:	January 31, 2025 (Estimated)
Total Intended Award Amount:	$275,000.00
Total Awarded Amount to Date:	$275,000.00
Funds Obligated to Date:	FY 2023 = $275,000.00
History of Investigator:	Nicolaos Christodoulides (Principal Investigator) christodoulides@oraliva.com John McDevitt (Co-Principal Investigator)
Recipient Sponsored Research Office:	ORALIVA, INC. 2 DAVIS DR DURHAM NC  US  27709-0003 (212)998-9204
Sponsor Congressional District:	04
Primary Place of Performance:	ORALIVA, INC. 2135 ARIELLE DR APT 2403 NAPLES FL  US  34109-0369
Primary Place of Performance Congressional District:	19
Unique Entity Identifier (UEI):	LMZ2DG9M4RH6
Parent UEI:
NSF Program(s):	STTR Phase I
Primary Program Source:	01AB2324DB R&RA DRSA DEFC AAB
Program Reference Code(s):	004E
Program Element Code(s):	150500
Award Agency Code:	4900
Fund Agency Code:	4900
Assistance Listing Number(s):	47.084

ABSTRACT

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will address the need for an accessible method to identify early-stage epithelial cancers, with high accuracy, earlier and at lower cost than is currently available. In 2020, the total cost of cancer care was nearly $210 billion. Due to the nature of current cancer diagnostics, most cancers are diagnosed and treated during late-stages. This results in a large economic burden to patients, families, healthcare providers, and facilities. To advance the health and welfare of the public and reduce the nation?s healthcare burden, there is a need for cancer screening, diagnostic, and monitoring devices that are non-invasive, cost-effective, easy-to-use, and accurate. The proposed platform for the early detection of multiple types of epithelial cancers 1) addresses the lack of effective non-invasive portable screening devices; 2) provides faster, more discriminatory assessments in near real-time; 3) yields the most precise and accurate results to identify cancers earlier, when interventions are more impactful, less expensive, less invasive, and more likely to improve patient outcomes.

This Small Business Technology Transfer (STTR) Phase I project seeks to establish the feasibility of developing the first portable, programmable, single cell cytology platform for early detection of multiple types of epithelial cancers, suitable for use at the point-of-care. The proposed technology will uniquely combine microfluidics and artificial intelligence (AI) to act as a sensor and provide predictive analysis, allowing for the accurate classification of potentially cancerous tissue. The platform will support near real-time, multiparameter, single-cell cytology measurements and will provide a method for automated analysis of a plurality of key metrics. Proof of concept has been established for the application area of oral cavity cancers, with the approach demonstrating superior performance metrics compared to other diagnostics (tissue reflectance, tissue auto fluorescence, salivary testing, and cytology testing). It is the only adjunct that can distinguish between mild, moderate, and severe dysplasia. The key objectives for this project are to develop methodologies to link different clinical specimen types to the microfluidics environment, and a biomarker discovery process to identify biomarkers for different applications that are amenable to the platform. The successful completion of this project will enable the platform to recognize and assess various levels of dysplasia across multiple epithelial cancer types.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

Cancer is a group of diseases of cellular dysfunction characterized by uncontrolled cellular growth and ability to spread throughout the body. Most cancer diagnostic tools focus on late-stage disease detection and are expensive, limiting their utility in early diagnosis, and widespread screening. To facilitate broad-scale early intervention, there is a compelling need to develop accurate, effective, minimally invasive diagnostic/adjunct tools which profile cells in real time, examining structure, morphology and molecular features to identify abnormalities indicative of malignancy. Current technologies can accomplish this only at high cost, and have limited application in early disease stage diagnosis. OraLiva's ONC In-CYT technology provides an answer to the need for an accurate point of care diagnostic. The ONC In-CYT technology represents the first portable, programmable single cell cytology platform that is suitable for early detection of epithelial cancers offering an accurate and cost effective method for diagnosis at the earliest stages of disease.

In Phase I, OraLiva addressed key knowledge gaps in applying the AI-linked cytopathology measurements at the point-of-care, moving closer to the production of a fully integrated system able to complete flow cell cytology with microfluidics routing, integrate fluorescence microscopy and complete these processes in a robust, automated manner. OraLiva and partners have completed the two main objectives of the project:

1. Development of methodologies for linking cervical and urothelial cancer samples to the microfluidics system; this required the establishment of appropriate sampling and sample storage methodologies, as well as the adjustment of assay/chemical buffer conditions.

2. Development of a biomarker discovery process to identify cervical and urothelial cancer biomarkers that are amenable to the ONC-InCYT platform; through this objective, the possible cross-indication of biomarker candidates were identified, as well as promising biomarker signatures of urinary and cervical cancer via cytology specimens. Successful preliminary diagnostic accuracy studies for the AI cytology test and integrated assay protocol development and optimization were also conducted, as well as initial studies on the reproducibility of AI linked cytology measurements.

Using cell-based measurements of wellness and disease states, ONC In-CYT offers technology that removes the subjectivity from POC diagnostics and detection. Commercialization of OraLiva's product will allow for accurate and efficient early-stage cancer detection, enabling healthcare providers to give patients the most appropriate treatment to increase the chances of survival.

 

Last Modified: 02/14/2025
Modified by: Nicolaos Christodoulides

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