softpap® a novel collection device for cervical cytology
TRANSCRIPT
A Novel Collection Device for Cervical Cytology
History of the Pap Smear
New cancer cases in the U.S. 2009 Estimates (Females):
Breast 192,370Uterus (womb) 42,160Ovary 21,550Cervix 11,270Vulva 4,000
Source: American Cancer Society, Cancer Facts and Figures 2009
How common is cervical cancer?500,000 women worldwide die of cervical
cancer annually60-65 million women in the U.S. have a
Pap test each year3-5 million women in the U.S. have an
abnormal result11,270 new cervical cancers diagnosed in
the U.S. in 20094,100 deaths from cervical cancer in the
U.S. per yearMost cervical cancer can be prevented
Pap SmearsConventional Liquid based monolayer (e.g.. Thin Prep)Spatula, Brush or Broom CollectionHPV testingAutomated Analysis
ClassificationBethesda System
Based on the probability of invasive cancer
Originally developed in 1998System revised in 2001Is the international gold standard for
classifying Pap specimens
Bethesda Classification (2001)Squamous Cell
Atypical squamous cells (ASC)Undetermined Significance (ASC-US)Not exclude High Grade (ASC-H)
Low Grade Squamous Intraepithelial lesion (LSIL) High Grade Squamous Intraepithelial lesion
(HSIL) Squamous Cell Carcinoma
Glandular Cell Atypical Glandular cells (AG)
Undetermined Significance (AG-US)Favors Neoplasm
Adenocarcinoma In Situ (AIS) Adenocarcinoma
Screening Guidelines for the Early Detection of Cervical Cancer
•Begin approximately 3 years after a women begins having vaginal intercourse, but no later than 21 years of age•Annually with regular Pap tests or every two years using liquid-based tests•At or after age 30: three normal test results in a row, screen every 2-3 years with cervical cytology alone(either conventional or liquid-based Pap test), or every 3 years with HPV DNA test plus cervical cytology•Women 70 and older who have had 3 or more consecutive Pap tests in the last 10 years may choose to stop cervical cancer screening•Screening not necessary after total hysterectomy (with cervix removal) unless done as a treatment for cervical cancer
American Cancer Society
Pap Test Abnormalities
60-65 million women screened
Cervical Cancer Detection and Treatment$7.6 billion Annual Expenditures in the United States
Approx. 65 million Pap Tests done in the US annually
Sources of Errors with Conventional Pap
Sampling errorsCells not collected on sampling deviceCollected cells not transferred to slideCells poorly preserved
Screening errorsCytologist misses abnormal cellsIncorrect classification of cells
*These errors all contribute to false negative results, with reported estimates ranging from 6-50%
SoftPAP® : A New Generation of Cervical Cell Collection
One-step collection of complete 360° sample
Collects both endocervical and ectocervical cells simultaneously
Less invasive and less traumatic specimen collection
Improved accuracy
SoftPAP® : Advantages over Conventional Methods
Statistically significant improvements vs. standard Spatula/Cytobrush
Improved sensitivityReduces false negatives by 26%
Improved specificityReduction of false positives of 33%
Ease of use for the provider
Greater patient comfort
Comparison of the Adequacy and Efficacy of SoftPAP® to Standard Specimen Collection for Cervical CytologyTrial Objective To demonstrate
equivalency of cervical cytology sampling using SoftPAP to conventional spatula/brush for cervical CA screening (Pap, HPV testing)
Patient Population 703 colposcopy clinic patients
Methods Randomized collection of cervical cytology specimens (compared for Pap, HPV testing)
Study Endpoints •specimen adequacy•sensitivity •specificity
SoftPAP® Results: Specimen Adequacy
SoftPAP® Results : Efficacy
* p <0.001
HPV vs. Cytology CorrelationSpatula/Brush
SoftPAP® Total
NHPV NEG
HPV POS N
HPV NEG
HPV POS N
HPV NEG
HPV POS
WNL1
53 66% 34% 58 67.2%
32.8%
111
66.7%
33.3%
ASC-
LSIL2
173
32.4%
67.6%
136
28.7%
71.3%
309
30.7%
69.3%
HSIL-
CA3
68 2.9% 97.1%
43 0% 100%
111
1.8% 98.2%
1 Within Normal Limits 2 Includes ASCUS, ASC-H, AGUS and LSIL3 Includes HSIL, CIS and Cancer
SoftPAP® Study Conclusions
Pinkerton, Guido, Ackerman, et al. Int J Obstet Gynecol, submitted 2009