CRISPR-Cas Assay for Rapid HPV Screening
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Solution Overview
Problem
Current cervical cancer screening methods are inefficient, requiring trained personnel, expensive equipment, and significant time, and do not provide comprehensive information on disease status, limiting their effectiveness in identifying high-risk HPV infections and associated cervical diseases.
Innovation Solution
A point-of-care CRISPR-based screening system using surface-modified polymeric and magnetic beads, isothermal amplification methods, and CRISPR-Cas technology for rapid detection of high-risk HPV infections and cervical disease markers, enabling self-collection of specimens, portable processing, and rapid results reporting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current cytology methods are used for cervical cancer screening, then trained personnel and significant infrastructure are required, but this increases device complexity and loss of time due to 1 to 2 weeks for completed results
Solution Approach 1:
The patent implements self-service through automated sample processing where the system automatically performs cell lysis, nucleic acid extraction, amplification, and detection without requiring manual intervention by trained personnel. The cartridge-based system guides the entire workflow autonomously, eliminating the need for complex infrastructure while maintaining detection accuracy.
Solution Approach 2:
The patent extracts the complex laboratory infrastructure requirements by implementing a portable, point-of-care device that performs all screening functions in a single cartridge. The system separates the detection function from centralized laboratories, enabling screening to be performed at the point of care with minimal equipment requirements.
2Productivity
If HPV screening is used to identify patients with infection, then throughput can be increased, but this does not provide information on disease status, requiring co-testing with cytology or biopsy
Solution Approach 1:
The patent merges HPV detection with cervical disease status assessment into a single integrated assay. The system simultaneously detects HPV DNA and analyzes cervical cell morphology and molecular markers within the same sample processing workflow, eliminating the need for separate co-testing while maintaining high throughput capability.
Solution Approach 2:
The patent implements multi-functionality by designing a single screening system that performs multiple functions: HPV detection, cervical cell analysis, and disease status assessment. The cartridge-based platform universally handles all these functions through automated processing, providing comprehensive screening information in one test.
3Productivity
If HPV testing is used as a stand-alone screen, then the prevalence of HPV infections in young women reduces the power to identify women at risk for cervical neoplasia or cancer
Solution Approach 1:
The patent applies local quality by analyzing specific molecular and morphological characteristics of cervical cells in addition to HPV detection. The system examines cell morphology, nuclear features, and molecular markers that are locally present in the cervical sample, providing localized information about disease risk that complements the HPV prevalence data.
Solution Approach 2:
The patent replaces the mechanical limitation of stand-alone HPV testing with molecular and morphological analysis capabilities. The system uses automated image analysis and molecular detection to substitute for the insufficient information provided by HPV testing alone, enabling accurate risk identification even in the context of high HPV prevalence.
4Loss of time
If rapid detection methods are implemented, then time-to-results is reduced, but this may compromise measurement precision and reliability
Solution Approach 1:
The patent implements preliminary action by pre-preparing reagents and processing protocols within the cartridge before the sample is introduced. The system has pre-loaded lysis buffers, extraction reagents, and detection components in optimized configurations, allowing rapid processing without compromising accuracy. The automated workflow is pre-programmed to execute precise timing and temperature control throughout the assay.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This system provides rapid, cost-effective, and convenient detection of HPV-related diseases at the point-of-care, reducing time-to-results and improving clinical information on disease status, enabling early identification and risk assessment of cervical neoplasia and cancer.
Implementation Method 1
surface-modified polymeric and magnetic beads for capture/enrichment of target sequences
Implementation Method 2
clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated (Cas) technology for detection of target species
Implementation Method 3
robust, low-cost, isothermal methods for target amplification such as LAMP/RT-LAMP, recombinase polymerase amplification (RPA)
Data Source
AI summary
The present disclosure provided methods, devices, and systems for CRISPR-based screening and detection of HPV-related diseases. In particular, the present disclosure provides a CRISPR-Cas assay for rapid, enhanced screening of cervical intraepithelial neoplasia (CIN) and cancer, which can also be applied to screening for other HPV-related anogenital or head and neck cancers, whose origin is based on infections with high-risk strains of human papillomavirus (hr-HPV).