Phase I - Development of Automated Hybrid Urine Cell Filtration Device

Examination of urothelial cells collected during urination offers a potential avenue for less invasive investigation through urine cytology. However, this process poses challenges due to the inherent instability of urine samples. Urine serves as a chemically hostile environment for suspended cells, leading to rapid degradation of urothelial cells if not promptly delivered to hospital pathology services. Without timely transport, these cells lose critical morphological and antigenic features essential for accurate diagnosis.

Previous research has led to the development of a disposable filtration-based device tailored for deployment to healthcare sites lacking laboratory facilities. This addresses the need to send samples to central path labs for processing, which often results in transport delays and sample degradation. The effectiveness of this approach in improving the diagnostic value of urine cytology has been demonstrated.

Despite successfully preserving the morphological and antigenic characteristics of cells, the initial device presented logistical challenges, particularly regarding the disposal of large volumes of engineered plastic waste contaminated with urine and containing clinical sharps. Additionally, bulk storage of device stock posed challenges.

In response to current environmental concerns regarding plastic waste, funding will be utilised to develop and validate an automated, cartridge-based system. This system will leverage similar proprietary membrane filtration technology as the previous device but with improved features. The new device will boast a compact bench footprint suitable for deployment in busy clinical facilities and will incorporate self-sanitisation and line flushing capabilities to eliminate potential cross-contamination between patients. Furthermore, disposable filter cartridges will address the issue of bulk plastic waste generated by earlier iterations of the device.

Urodyne

UGenDX Manufactured Prototype

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