Invention:
The TWICE (Transvaginal Widefield Imaging and Confocal Endoscope) invention is a low-cost, portable confocal endomicroscope for cervical malignancy diagnosis. The device combines the capabilities of widefield imaging (similar to mobile colposcopy) and confocal microscopy images, allowing users to obtain both macroscopic and high-resolution microscopic views of the cervix using a single device. This allows for a broader and more precise examination to ensure that no abnormalities are missed, as well as high sensitivity and specificity for malignancy detection, enabling accurate diagnoses. The endomicroscope is made from high-performance, low-cost, optoelectrical components, while creating high resolution images equivalent to those of high-cost confocal microscopy devices. With this invention, early detection and diagnosis of cervical malignancy can become more widespread, ultimately leading to improved patient outcomes and a reduction in healthcare disparities.
Background:
Timely, accurate diagnosis and treatment of cervical precancer remains a significant healthcare challenge in low- and middle- income countries (LMICs). More than 80% of the 570,000 annual cervical cancer cases and 311,000 annual cervical cancer-related deaths occur in LMICs, due to the lack of resources for conducting organized screening and treatment services. In 2018, the World Health Organization (WHO) called for immediate action to end cervical cancer with a plan emphasizing the importance of screening, diagnosis, and treatment.
Human papillomavirus (HPV) testing of self-collected samples is gaining traction as the first line screening method for cervical malignancy in LMICs. While HPV testing provides a sensitive and quantitative biomarker, a significant portion of the women with a positive HPV test will clear the HPV infection and never develop malignant diseases, which leads to overtreatment that causes an increased burden on the health care system, unnecessary adverse effects (pain, bleeding, discharge, and psychological distress), and an increased risk of adverse obstetric outcomes. Those that do develop disease also undergo additional tests that are often invasive and may not yield accurate results. Mobile colposcopes and imaging methods such as confocal microscopy and optical coherence tomography (OCT) are now being used for medical diagnostic purposes, yet challenges remain with providing affordable devices that generate reliable results to improve patient outcomes.
Applications:
- Endomicroscopy
- Cervical imaging
- Screening programs in low-resource settings
Advantages:
- Portable
- Low-cost device
- High resolution images
- High sensitivity and specificity
- Improved healthcare equity
