The SurePath™ Liquid-Based Cytology System is the only FDA-certified LBC method clinically proven to reduce unsatisfactory specimen rates by 58%, offering the highest cervical precursor lesion detection sensitivity among all commercially available LBC platforms.
Cervical cancer screening depends critically on the quality of the collected specimen. Conventional Pap smears frequently yield unsatisfactory slides due to obscuring blood, mucus or insufficient cellular material — resulting in repeat collection appointments, diagnostic delays and increased anxiety for patients. SurePath™ addresses these limitations head-on through its patented detachable brush-tip collection system and proprietary density-gradient centrifugation technology.
How SurePath™ Works
The SurePath™ collection device features a unique detachable tip design: after cervical sampling, the brush tip is deposited directly into the preservative solution vial rather than being discarded, ensuring that 100% of the collected cellular material is retained. This contrasts sharply with conventional methods where residual cells remaining on the brush shaft are lost.
In the laboratory, the SurePath vial is processed using the PrepStain™ Slide Processor — an automated system that employs density-gradient centrifugation to separate epithelial cells from blood, mucus and inflammatory elements. The resulting slide presents a uniform cellular monolayer approximately 13 mm in diameter, enabling rapid, systematic microscopic review.
Clinical Performance Advantages
Published clinical data consistently demonstrate that SurePath™ outperforms both conventional cytology and competing LBC platforms across a range of diagnostic metrics:
- Unsatisfactory specimen rate reduced by 58% compared to conventional Pap smear
- HSIL+ detection rate 64.4% higher than conventional Pap smear
- LSIL detection rate improved by 107% over conventional collection methods
- 100% sample collection — no cell loss during transport due to the detachable brush-tip design
- Compatible with both gynaecological and non-gynaecological applications
Regulatory Approvals and Certification
SurePath™ holds the FDA Pre-Market Approval (PMA) — the highest level of regulatory clearance for in vitro diagnostic devices in the United States. It is the only LBC system to achieve this certification, distinguishing it from competitors that hold only the lower-tier 510(k) clearance. In China, SurePath™ has received full NMPA (National Medical Products Administration) registration, allowing legal commercial distribution across all mainland Chinese healthcare institutions.
“SurePath™ is the only LBC method proven, under FDA PMA standards, to statistically and significantly reduce unsatisfactory rates compared to conventional cytology — a distinction that matters deeply in high-volume screening programmes.”
Laboratory Integration and Automation
The SurePath™ system integrates seamlessly with the PrepStain™ Slide Processor and FocalPoint™ GS Imaging System. This end-to-end automated workflow significantly reduces manual processing time, inter-laboratory variability and the risk of transcription errors. Laboratories can process large batches of specimens with consistent, reproducible quality — an important consideration for tertiary hospitals and reference laboratories managing high throughput volumes.
Additionally, SurePath™ vials are compatible with reflex HPV testing using the Onclarity™ HPV Assay and other validated molecular platforms, enabling co-testing from a single collected specimen without the need for a second patient visit.
Applications in the Greater Bay Area
Hong Kong Origins Investment Limited supports healthcare providers across the Greater Bay Area in adopting SurePath™ as the foundation of their cervical cancer screening programmes. Our team provides end-to-end service including product registration support, laboratory installation coordination, staff training and ongoing technical assistance.
To request a product demonstration or discuss procurement options for your facility, please contact our medical device specialists.