Techcyte SureView Cervical Cytology System Clinical Validation Study

Launched by TECHCYTE, INC. · Jan 6, 2025

Keywords

ClinConnect Summary

This study is testing whether an AI tool called Techcyte SureView can read Pap test slides as accurately as the standard lab method used by doctors. The goal is to show the AI method is not worse than the current approach at detecting cervical cell changes that could indicate a borderline or more concerning finding (called LSIL+). Digital images of Pap slides prepared with ThinPrep or SurePath are analyzed by the AI, while human readers still review the same slides using established guidelines, so researchers can compare the two methods.

Participants come from stored Pap slide samples collected in the United States and are adult women (18 and older). To be eligible, slides must have a clear, original diagnosis, be in good condition, and be relatively recent (five years or less); only one sample per patient is used. The study does not involve new testing on living people. It’s retrospective (looking back at existing data) and blinded, with enrollment by invitation and an estimated 4,596 samples planned. If successful, the AI method could help speed up lab work while keeping accuracy high. The project is led by Techcyte and uses their digital scanner and AI software.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Glass slides with cervical cytology specimens prepared with Hologic ThinPrep according to the pap test manufacturers Instructions for Use (IFU) using any of Hologic's processors (i.e. ThinPrep2000, ThinPrep 3000, ThinPrep 5000, ThinPrep Genesis). OR Glass slides with cervical cytology specimens prepared with BD SurePath according to the pap test manufacturers IFU using any of BD's processors (i.e. BD Totalys MultiProcessor, BD Totalys SlidePrep, BD PrepStain).
• • Slide has the original diagnosis available.
• • Slides that fit within the required sample size strata using the sample collection procedure.
• • Glass slides with QR code, barcodes, or plain text labels.
• • Glass slides with coverslips.
• • Slides that are 5 years old or less, except where rare specimens require it. Those specimens will have to be reviewed for degradation per the sample collection procedure.
• • Only one sample per patient and all are to be collected, processed and scanned.
• Exclusion Criteria:
• • Broken or cracked slides.
• • Slides with air bubbles or scratched, cracked or broken/missing cover slips.
• • Slides with markings (e.g., handwritten pen marking) that cannot be removed according to standard laboratory procedures.
• • Degraded slides (ex: slides whose stains have lost color or specimens that are not intact).
• • Glass slides with cervical cytology specimens prepared with methods other than Hologic ThinPrep or BD SurePath.
• • Glass slides with specimens other than cervical cytology specimens.
• • Slides from the same patient.