A validation study of the FocalPoint GS imaging system for gynecologic cytology screening

Colgan, Terence J.; Bon, Nereo; Clipsham, Susan; Gardiner, Geoffrey W.; Sumner, Jeff; Walley, Virginia M.; McLachlin, C. Meg

doi:10.1002/cncy.21271

Cited by 16 publications

(29 citation statements)

References 7 publications

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“…Although not as many follow‐up studies of the performance of FocalPoint GS have appeared in the literature as compared with the Imager, several investigators have reported that the system performs at least as well as manual screening in routine clinical use . The FocalPoint GS system continues to be the only FDA‐approved and widely‐used automated screening system for SurePath liquid‐based cytology slides.…”

Section: Papnetmentioning

confidence: 99%

Automated screening of Papanicolaou tests: A review of the literature

Thrall

2018

Diagnostic Cytopathology

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Automated Papanicolaou test screening systems have now been available for over 25 years. Currently two automated screening systems are in widespread clinical use. These are the ThinPrep Imaging System and the FocalPoint GS Imaging System. In their current configurations, both facilitate faster screening by showing a limited number of fields of view (FOV) to cytotechnologists. The FOV are based on the use of proprietary algorithms applied to computerized images of the slide that determine the cells and cell groups with the highest likelihood of abnormality. If all of the FOV are deemed to be negative, the case can be signed out with no additional review; if one or more fields appear possibly abnormal, the entire slide must be manually screened. The United States Food and Drug Administration has ruled that for workload calculation purposes, looking at only the FOV review counts as one-half slide, potentially greatly increasing the number of slides that can be screened. However, follow-up studies of this technology have shown that screening accuracy declines when very large numbers of cases are reviewed per day. Recommendations designed to limit screening volumes to levels that do not jeopardize patient care have therefore been created. The development of fully automated screening that does not rely on human judgment remains an unrealized aspiration. This review covers the history of the development and clinical implementation of automated screening technology with descriptions of the various automated screening systems and their performance as reported in published literature.

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Section: Papnetmentioning

confidence: 99%

Automated screening of Papanicolaou tests: A review of the literature

Thrall

2018

Diagnostic Cytopathology

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“…However, the reliability of ‘no further review’ warranted further consideration as a means of saving staff time . The study by Colgan et al concluded that there was no evidence that FPGS [FocalPoint GS imaging system] has diagnostic performance that is different from manual screening for carcinoma, HSIL+ or LSIL+ [low‐grade squamous intraepithelial lesion or worse]; however, the performance of FPGS in detecting lower grade lesions (LSIL and ASC‐US [atypical squamous cells of undetermined significance] alone) was less than that of manual screening …”

Section: Introductionmentioning

confidence: 99%

A retrospective validation of the FocalPoint GS slide profiler NFR technology by analysis of interval disease outcomes compared with manual cytology

Nuttall

Hillier

Clayton

et al. 2019

Cancer Cytopathology

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Background To the authors’ knowledge, published studies reporting on the performance of the FocalPoint GS (FPGS) imaging system have yielded conflicting results to date. However, the results of the MAVARIC study indicated that the FPGS “No Further Review” (NFR) aspect of the technology demonstrated potential and warranted further investigation. The current validation study was performed prior to implementing the NFR slide reporting technology within the routine cervical screening program in Wales, United Kingdom. Methods A total of 45,317 SurePath liquid‐based cytology cervical screening samples were submitted for FPGS scanning by 4 Welsh laboratories between 2006 and 2011. The current study (Computer Assisted Evaluation, Screening and Reporting [CAESAR]), reports on a comparison between slides categorized as NFR (8130 slides) and slides manually screened as negative (93,473 slides). Both interventions had a subsequent negative quality control screen. Results The histological outcome rates of cervical intraepithelial neoplasia 2 (CIN‐2) (high‐grade squamous intraepithelial lesion or worse [HSIL+]) at 2 years and subsequently 3 years after an FPGS NFR result versus a manually screened negative result were compared. Significantly fewer cases were detected in the NFR cohort compared with the manually screened cohort (P = .043 at 2 years and P = .027 at 3 years). When these cases were subcategorized as cancers and precancers, the interval cancer prevalence between NFR and manually screened samples at 2 years and 3 years was similar; however, the interval precancer prevalence for FPGS NFR was significantly lower (P = .023 at 2 years and P = .026 at 3 years) at approximately one‐half that of manual screening. Conclusions The negative predictive potential of the FPGS NFR technology is higher than that of manual screening, and the technology has quality/throughput benefits to support and enhance a laboratory cervical screening service.

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“…The replacement of manual screening by automated analysis followed by manual screening of merely designated cases has been a matter of debate in many countries worldwide, with conflicting results in the literature [6,7,8]. A recent clinical study in Canada looking at more than 10,000 slides read by the BD FocalPoint showed that the detection of ASC-US and LSIL by automated analysis is significantly lower than that by manual revision of slides, suggesting an improvement in the detection of abnormal cells by the image-guided computer system before it was globally incorporated into clinical practice [6].…”

Section: Discussionmentioning

confidence: 99%

“…A recent clinical study in Canada looking at more than 10,000 slides read by the BD FocalPoint showed that the detection of ASC-US and LSIL by automated analysis is significantly lower than that by manual revision of slides, suggesting an improvement in the detection of abnormal cells by the image-guided computer system before it was globally incorporated into clinical practice [6]. However, our results show a fair equivalence between the automated and manual analysis, which has been previously reported by a large Finnish study [13], where, although there was a statistical difference between cases diagnosed as LSIL, ASC-H and HSIL, the overall difference was smaller than in other nonrandomized trials [14,15].…”

Section: Discussionmentioning

confidence: 99%

“…Although many papers in the literature discuss the usefulness of automated analysis applied to liquid-based preparations [6,7,8], little is discussed for conventional smears [1,2,9,10], which remain the cheapest and most convenient method for early detection of cervical cancer in low-income countries, where this type of cancer is a major health problem [11]. In the current study, we tested the ability of automated screening using the BD FocalPoint Imaging Analyzer (Becton Dickinson, Franklin Lakes, N.J., USA) in processing conventional gynecological cytology smears as well as its efficacy in assessing sample adequacy and stratifying cases for risk of malignancy when compared to the manual revision of slides.…”

Section: Introductionmentioning

confidence: 99%

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Automated Screening of Conventional Gynecological Cytology Smears: Feasible and Reliable

et al. 2014

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Objectives: We tested the ability of automated screening in processing conventional gynecological cytology smears and its efficacy in assessing sample adequacy and stratifying cases for risk of malignancy. Study Design: Cases were retrospectively selected, including unsatisfactory samples and slides with various sorts of artifacts. Automated screening was performed using the FocalPoint GS Imaging System (Becton Dickinson, Franklin Lakes, N.J., USA), with classification into five quintiles. For agreement purposes, cases were grouped into high risk for malignancy (quintiles 1 and 2) and low risk for malignancy (quintiles 3, 4 and 5). Results: A total of 120 cases (median age 37.5 years, range 18-85) were included in the study. Eighty-three cases (69.2%) could be successfully classified into quintiles. When divided by risk, 31 cases were placed in the high-risk and 52 in the low-risk group. The overall sensitivity and specificity of the automated analysis was 100 and 70.3%, respectively. Conclusions: Automated analysis could analyze the majority of conventional smears, including one case previously screened as unsatisfactory. All malignant and high-grade lesions were correctly classified into the high-risk group. Broad use of this automation system could potentially decrease screening time and augment the efficacy in detecting precursor neoplastic changes in cervical cytology smears.

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A validation study of the FocalPoint GS imaging system for gynecologic cytology screening

Cited by 16 publications

References 7 publications

Automated screening of Papanicolaou tests: A review of the literature

Automated screening of Papanicolaou tests: A review of the literature

A retrospective validation of the FocalPoint GS slide profiler NFR technology by analysis of interval disease outcomes compared with manual cytology

Automated Screening of Conventional Gynecological Cytology Smears: Feasible and Reliable

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