Point of care diagnostic to improve access to gynecological screening in low-resource settings

OraLiva and partners propose to develop a novel, low cost, fully integrated gynecological screening test that exhibits comparable accuracy at the point of care (POC) to current remote lab tests. Providing adequate gynecological screening to underserved areas (e.g., rural) remains a significant challenge. POC testing has potential to increase the accessibility of diagnostic services while reducing the number of follow-up clinic visits, reducing the likelihood of loss to follow-up, and ensuring that women receive timely diagnosis and treatment. However, POC modalities typically exhibit reduced sensitivity and specificity compared to their lab-based counterparts, pointing to the need for more sophisticated POC gynecological diagnostics that can offer improved diagnostic accuracy. Nearly 1 in 11 Americans rely on Federally Qualified Health Centers (FQHCs) for their medical care. Effectiveness of screening in the gynecological setting varies across FQHCs, largely because of a lack of quality POC tests. Additionally, the level of agreement between cytologists on dysplasia stage is relatively poor, and a shortage of medical specialists at FQHCs affects treatment decisions, resulting in decreased quality of life and higher mortality rates for these patients. While repeated testing may overcome some shortcomings of the low sensitivity of cytology-based tests, it can lead to loss of follow-up for patients who are most at-risk. Recognizing these issues, OraLiva is leveraging its powerful artificial intelligence (AI)-linked cytomics-on-a-chip technology (ONC-InCYT) to develop the first rapid, POC, combination human papillomavirus (HPV) and cervical cancer screening tool. The ONC-InCYT combines a microfluidic engine with AI to act as a sensor and provides predictive analysis while allowing multi-parameter single-cell cytology measurements to be completed in near real-time. Critically, the instrument has a small footprint making it ideal for use in a near patient setting. For this Phase I project, OraLiva will 1) Use the OraLiva analyzer and cartridge to optimize the cytology assay for a cervical cancer cytology diagnostic and develop the preliminary single-cell cytology diagnostic models for cervical cancer screening; 2) Establish proof-of-concept HPV results for RNA in situ hybridization assay using the same cervical specimen as cytology; and 3) Define user specifications for Cervical ONC-InCYT platform to meet requirements of the FQHCs. By addressing the need for accessible, improved diagnostic accuracy, OraLiva’s integrated HPV and cytology test will capture disease at precancer/cancer stage, leading to transformative changes in the management and treatment of cervical cancer. Successful development of the proposed diagnostic is expected to address the lack of effective, non-invasive POC screening devices in under-served areas, provide faster, more discriminatory assessments in near real-time, and allow for expansion of expert cervical screening capabilities to rural clinical settings, democratizing diagnostic capability across the U.S. Project Number: 1R41CA298398-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Nicolaos Christodoulides | Institution: ORALIVA, INC., NAPLES, FL | Award Amount: $400,000 | Activity Code: R41 | Study Section: Special Emphasis Panel[ZRG1 CDPT-V (13)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11186207