2 BD FocalPoint™ slide profiler
2.1 Peer-reviewed BD FocalPoint™ Slide Profiler & BD SurePath™ Pap test (2000-2005)
2.2 Peer-reviewed BD FocalPoint™ Slide Profiler & Conventional Pap smear (2000-2005)
2.3 Peer-reviewed BD FocalPoint™ GS Imaging System (2000-2005)
2.4 Peer-reviewed AutoPap 300 QC System studies
2.5 Peer-reviewed BD FocalPoint™ Slide Profiler & BD FocalPoint™ GS Imaging System (Pre-year 2000)
2.6 Non-peer Reviewed BD FocalPoint™ Slide Profiler publications
2.1 Peer-reviewed BD FocalPoint™ Slide Profiler & BD SurePath™ Pap test
(2000-2005)
Vassilakos P, Carrel S, Petignat P, Boulvain M, Campana A.
Use of Automated Primary Screening on Liquid-Based, Thin-Layer Preparations.
Acta Cytologica 2002 March-April 46:2:291-295.
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2.2 Peer-reviewed BD FocalPoint™ Slide Profiler & Conventional Pap smear (2000-2005)
Rowe LR, Marshall CJ, Berry M, Larson MA, Bentz JS.
Accuracy of a Slide Profiler for Endocervical Cell Detection in a No-Further Review Conventional Pap Smears.
Acta Cytologica 2003 July-Aug;47 (4):602-604.
Walts AE, Thomas P.
Endometrial cells and the AutoPap System for primary screening of cervicovaginal Pap smears.
Diagnostic Cytopathology 2002; 27(4):232-7.
Wilbur DC, Norton M.
The Primary Screening Clinical Trials of the TriPath AutoPap System.
Epidemiology 2002 May;13 (3 Suppl): S30-3.
Tench W.
Validation of AutoPap Primary Screening System Sensitivity and High-Risk Performance
Acta Cytologica 2002 March-April 46:2:296-302.
Alasio LM, Alphandery C, Grassi P, Ruggeri M, De Palo G, Pilotti S.
Performance of the AutoPap Primary Screening System in the Detection of High-risk cases in Cervico-Vaginal Smears.
Acta Cytologica 2001 Sept-Oct;45:5:704-8.
Renshaw AA,
Estimating the Percentage of Papanicolaou Smears that can be Reproducibly Identified: Modeling Papanicolaou Smear Interpretation Based on Multiple Blinded Rescreenings.
Cancer 2001 Aug 25;93:4:241-5.
Renshaw AA, Lezon KM, Wilbur DC.
The Human False-negative Rate of Rescreening Pap Tests. Measured in a two-armed Prospective Clinical Trial.
Cancer 2001 Apr 25:93:2:106-110.
Wiley BB, Matz LR.
Use of the AutoPap as a Primary Automated Cervical Cancer Screening System.
Medical Journal Australia 2001 Feb 5;174:3:151-2.
McQuarrie H, Ogden J, Costa M.
Understanding the Financial Impact of Covering New Screening Technologies: The Case of Automated Pap Smears.
Journal of Reproductive Medicine 2000; 45(11): 898-906.
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2.3 Peer-reviewed BD FocalPoint™ GS Imaging System (2000-2005)
(This section contains articles whose information has not been approved or cleared by the Food and Drug Administration in the United States)
Parker EM, Foti JA, Wilbur DC.
FocalPoint Slide Classification Algorithms Show Robust Performance in Classification of High-Grade Lesions on SurePath® Liquid-Based Cervical Cytology Slides.
Diagnostic Cytopathology Feb 2004. Vol 30(2) 107-110.
Stevens MW, Milne AJ, Parkinson IH, Nespolon WW, Fazzalari NL, Arora N, Dodd TJ.
Effectiveness of AutoPap system location-guided screening in the evaluation of cervical cytology smears.
Diagn Cytopathol. 2004 Aug;31(2):94-9.
Ronco G et al.
Impact of the Autopap (Currently FocalPoint) Primary Screening System Location guided Use on Interpretation time and diagnosis.
Cancer Cytopathology April 25, 2003. Vol. 99 (2): 83-88.
Confortini M., Bonardi L., Bulgaresi P., et al.
A feasibility stuffy of the use of the AutoPap Screening system as a primary screening and location-guided re-screening device.
Cancer Cytopathology. June 25, 2003. Vol. 99(3):129-134.
Wilbur DC., Parker EM, Foti JA.
Location-Guided Screening of Liquid-Based Cervical Cytology Specimens. A Potential Improvement in Accuracy and Productivity is Demonstrated in a Preclinical Feasibility Trial.
American Journal of Clinical Pathology 2002;118:399-407
Chang AR, Lin WF, Chang A, Chong KS.
Can Technology Expedite the Cervical Cancer Screening Process? A Hong Kong Experience Using the AutoPap Primary Screening System with Location Guided Screening Capability.
American Journal of Clinical Pathology 2002 March;117(3)437-43.
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2.4 Peer-reviewed AutoPap 300 QC System studies
(The AutoPap 300 QC System was approved for use in the US as a quality control device in 1996. Effective January 1, 2000. the AutoPap 300 QC device was no longer commercially available. It has been replaced with the FocalPoint™ slide profiler for primary screening for both the SurePath®liquid-based Pap test and the conventional Pap smear)
Abulafia O, et.al.
Automated Cervical Cytology: Meta-analysis of the Performance of the AutoPap® 300 QC System.
Obstet gynecol Surv. 1999 Jul; 54(7): 469-76.
Fetterman B, Pawlick G, Koo H, Hartinger J, Gilber C, Connell S.
Determining the Utility and Effectiveness of the NeoPath AutoPap® 300 QC System Used Routinely.
Acta Cytologica 1999; 43(3): 13-22.
Marshall CJ, Rowe L, Bentz JS.
Improved Quality-Control Detection of False-negative Pap smears Using the AutoPap® 300QC System.
Diagn Cytopathol 1999; 20(3): 170-4.
Berry MC, Bentz J, Farnsworth R, Marshall CJ.
Evaluation of the AutoPap® 300 QC System for Improving Detection of Endometrial Disease.
Acta Cytologica 1998; 42: 1252.
Colgan T, Bon N, Lee J, Patten S.
AutoPap® 300 QC System Scoring of Cervical Smears Without “Epithelial Cell Abnormalities”.
Acta Cytologica 1997; 41: 45-49.
Colgan T, Smith J, Patten S, Lee J.
Enhancing the Performance of the AutoPap® 300 QC System with Optimal Staining and Presentation of Cervical Smears.
Acta Cytologica 1997: 41: 50-55.
Kaminsky F, Benneyan J, Mullins D.
Automated Rescreening in Cervical Cytology.:Mathematical Models for Evaluating Overall Process Sensitivity, Specificity and Cost
Acta Cytologica 1997; 41: 209-223.
Patten SF, et al.
The AutoPap® 300 QC System Multicenter Clinical Trials for Use in Quality Control Rescreening of Cervical Smears: I A Prospective Intended Use Study.
Cancer 1997 Dec 25; 81 (6): 337-42.
Patten SF, Lee J, Wilbur DC, et al.
The AutoPap® 300 QC System Multicenter Clinical Trials for Use in Quality Control Rescreening of Cervical Smears: II Prospective and Archival Sensitivity Studies.
Cancer Cytopathology.
1997 Dec 25; 81 (6): 343-7.
Stevens M, Milne A, James KA, Brancheau D, et al.
Effectiveness of Automated Cervical Cytology Rescreening Using the AutoPap® 300 QC System.
Focus on Technology 1997; 16: 505-512.
Wilbur DC, Bonfiglio TA, Rutkowski, Atkison K.
Sensitivity of the AutoPap® 300 QC System to Cervical Cytologic Abnormalities: Biopsy Data Confirmation.
Acta Cytologica 1996; 40: 127-132.
Colgan T, Patten S,Lee J.
A Clinical trial of the AutoPap® 300 QC System for Quality Control of Cervicovaginal Cytology in the Clinical Laboratory.
Acta Cytologica 1995; 39: 1191-1198.
Anderson TL.
Automatic Screening of Conventional Cytologic Smears: The AutoPap® 300 and AutoPap® 300 QC Systems.
Tutorial of Cytology 1994; 306-11.
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2.5 Peer-reviewed BD FocalPoint™ slide profiler & FocalPoint™ GS Imaging System (Pre-year 2000)
Bibbo M, Hawthorne C, Zimmerman B.
Does Use of the AutoPap® Assisted Primary Screener Improve Cytologic Diagnosis?
Acta Cytologica 1999: 43(1): 23-26.
Bibbo M. Hawhorne C.
Performance of the AutoPap® Primary Screening System at Jefferson University Hospital.
Acta Cytologica 1999; 43(1): 27-29.
Brown AD, Garber AM.
Cost-effectiveness of 3 Methods to Enhance the Sensitivity of Papanicolaou Testing.
JAMA 1999; 27(4): 347-353.
Smith B, Lee M, Leader S, Wertlake P.
Economic Impact of Automated Primary Screening for Cervical Cancer.
Journal of Reproductive Medicine 1999; 44: 6.
Wertlake P.
Results of AutoPap® System-assisted and Manual Cytology Screening. A Comparison.
Journal of Reproductive Medicine. 1999; 44(1): 11-17.
Wilbur D, Prey M, Miller W, Pawlick G, Colgan T, Taylor D.
Detection of High Grade Squamous Intraepithelial Lesions and Tumors Using the AutoPap® System: Results of a Primary Screening Clinical Trial.
Cancer Cytopathology 1999; 87(6): 354-358.
Wilbur D, Prey M, Miller W, Pawlick G, Colgan T.
AutoPap® System Detection of Infections and Benign Cellular Changes: Results from the Primary Screener Clinical Trials.
Diagnostic Cytopathology 1999; 21: 355-358.
Lee J, Nelson A, Wilbur DC, Patten SF.
The Development of an Automated Papanicolau Smear Screening System.
Cancer 1998; 81: 332-6.
Wilbur DC, Prey MU, Miller WM, Pawlick GF, Colgan TJ:
The AutoPap® System for Primary Screening in Cervical Cytology: Comparing the Results of a Prospective Intended –Use Study with Routine Manual Practice.
Acta Cytologica 1998; 42: 214-220.
Wilhelm P, Kuan L, Lee J, et al.
AutoPap® System Performance in Screening for Low Prevalence and Small Cell Abnormalities.
Acta Cytologica 1997 Jan-Feb; 41(1): 56-64.Huang TW, Lin TSM,
Shih-Jong Lee J:
Sensitivity Studies of AutoPap® System Location-Guided Screening of Cervical-Vaginal Cytologic Smears.
Acta Cytologica 1999; 43(3): 363-368.
Lee J, et al.
A feasibility study of the AutoPap® System Location Guided Screening.
Acta Cytologica 1998;42(1): 226-6.
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2.6 Non-peer Reviewed BD FocalPoint™ slide profiler publications
Kardos TF.
The FocalPoint System: FocalPoint slide profiler and FocalPoint GS.
Cancer. 2004 Dec 25;102(6):334-9.
Wilbur D et al.
Cervical cytology automation: an update for 2003. The end of the quest nears?.
Clin Lab Med 23 (2003):755-774.
Bishop JW, Marshall CJ, Bentz JS
New Technologies in Gynecologic Cytology.
J. Reproductive Medicine 2000;45:9:701-719.
Frable WJ., Vooijs GP., Henry MR., Bonfiglio TA,, Wilbur DC., Lee JSJ.
A Tribute to Stanley F. Patten, Jr.,M.D.,Ph.D.
December 1997.Vol 81(6);315-336
Patten SF, Lee J, Nelson A.
NeoPath® AutoPap® 300 Automatic Pap Screener System.
Acta Cytologica. 1996 Jan-Feb; 40(1): 45-52.
Lee J, Nelson A, Patten SF.
The AutoPap® 300 Automatic Pap Screener System.
ASCT News. 1995; 16: 57-58.
