Screening and assessment of potentially malignant oral lesions
Inventors
McDevitt, John T. • McRae, Michael P.
Assignees
Publication Number
US-12235272-B2
Publication Date
2025-02-25
Expiration Date
2041-01-13
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Abstract
The present disclosure is related to systems and methods to be used as aids in the diagnosis of risk for oral cancer, potentially malignant oral lesion (PMOL), and/or oral epithelial dysplasia (OED) by identifying cellular phenotype characteristics of cell samples, including percentage of mature squamous cells, presence or absence of nuclear actin in mature squamous cells, percentage of non-mature squamous cells, percentage of small round cells, percentage of white blood cells, and percentage of lone nuclei.
Core Innovation
The invention provides systems and methods for aiding in the diagnosis and assessment of risk for oral cancer, potentially malignant oral lesions (PMOL), and oral epithelial dysplasia (OED) by identifying specific cellular phenotype characteristics in cell samples. The approach analyzes parameters such as percentage of mature squamous cells, presence or absence of nuclear actin in mature squamous cells, percentage of non-mature squamous cells, percentage of small round cells, percentage of white blood cells, and percentage of lone nuclei. Automated techniques, including machine learning algorithms, enable accurate identification and classification of these cell types within biological samples obtained non-invasively, such as via brush cytology.
A key feature of the method is determining cellular phenotype characteristics, with special emphasis on the percentage of mature squamous cells expressing nuclear actin; the presence of nuclear actin in 10%–30% of mature squamous cells is used to indicate the presence of oral disease. Additional measurements may include cell morphological characteristics (such as nuclear area, cell area, circularity, aspect ratio, and roundness), and biomarker expression (including AVB6, EGFR, Ki67, Geminin, MCM2, beta catenin, EMPPRIN, CD147, Cofilin, Importin 9, Profilin, thymosin-β4, WASp, Arp2/3 complex, and formins). Data from demographics, morphology, and biomarkers are optionally processed with statistical and machine learning models such as artificial neural networks and logistic regression to assess disease status and severity.
The problem addressed by this invention is the need for precise, rapid, and minimally invasive diagnostic tools for detecting and stratifying the risk of oral diseases, including OED and oral cancer. Current diagnostic paradigms rely on biopsies and remote laboratory services, which are time-consuming and may not capture the heterogeneity of lesions, resulting in sampling errors and delays. The invention aims to provide an automated, point-of-care solution capable of delivering immediate feedback to clinicians and improving early identification and management of oral lesions.
Claims Coverage
The patent contains one independent claim and several dependent claims, covering multiple inventive features related to analyzing cellular phenotype characteristics to assess and manage oral disease.
Assessing oral disease risk via nuclear actin in mature squamous cells
A method involves: - Identifying at least one cellular phenotype of one or more cells in a subject's sample. - Determining the percentage of mature squamous cells expressing nuclear actin in the sample. - Using this cellular phenotype characteristic to assess the presence or severity of oral disease (oral cancer, PMOL, or OED), where 10%–30% nuclear actin positivity among mature squamous cells indicates presence of disease. - Treating the identified disease with a regimen selected from chemotherapy, radiation, hormone therapy, surgery, or targeted therapy.
The main inventive feature is a diagnostic and treatment method based on quantifying nuclear actin expression in mature squamous cells, enabling assessment and management of oral diseases. Dependent claims expand on measuring additional cellular phenotypes, cell morphology, biomarker levels, demographic integration, risk scoring, and treatment assessment.
Stated Advantages
Enables rapid, point-of-care assessment of oral lesions, delivering results within minutes compared to days with traditional methods.
Improves diagnostic accuracy for oral cancer, PMOL, and OED by integrating cellular phenotypes, morphology, biomarkers, and demographic data.
Reduces the need for invasive biopsy procedures by using minimally invasive sampling (such as brush cytology).
Facilitates more efficient referral, screening, and longitudinal monitoring in primary, secondary, and tertiary care settings.
Simplifies interpretation and increases transparency for cytopathologists and clinicians through automated analysis and clear risk indices.
Documented Applications
Screening and assessment of potentially malignant oral lesions (PMOL) in clinical settings using minimally invasive samples.
Assisting in the diagnosis, assessment of progression, severity classification, risk scoring, and evaluation of treatment effectiveness for oral cancer, PMOL, and OED.
Providing point-of-care testing for rapid feedback to clinicians in primary, secondary, and tertiary care environments.
Supporting surveillance and longitudinal monitoring of patients with a history of OED and oral squamous cell carcinoma (OSCC).
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