Transcript Slide 1

SoftPAP®
 A Novel Collection Device for Cervical Cytology
History of the Pap Smear
1943Papanicolaou
published
paper on
significance
1928-First
discovered by of vaginal
smears in
Dr. George
Papanicolaou diagnosis of
carcinoma of
the uterus
1945- Pap
Smear adopted
by ACS as
cervical cancer
screening tool
New cancer cases in the U.S.
2009 Estimates (Females):
 Breast
 Uterus (womb)
 Ovary
 Cervix
 Vulva
192,370
42,160
21,550
11,270
4,000
Source: American Cancer Society, Cancer Facts and Figures 2009
How common is cervical cancer?
 500,000 women worldwide die of cervical cancer
annually
 60-65 million women in the U.S. have a Pap test
each year
 3-5 million women in the U.S. have an abnormal
result
 11,270 new cervical cancers diagnosed in the U.S. in
2009
 4,100 deaths from cervical cancer in the U.S. per
year
Most cervical cancer can be prevented
Pap Smears
 Conventional
 Liquid based monolayer (e.g.. Thin Prep)
 Spatula, Brush or Broom Collection
 HPV testing
 Automated Analysis
Classification
 Bethesda System
 Based on the probability of invasive cancer
 Originally developed in 1998
 System revised in 2001
 Is 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 liquidbased 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 liquidbased 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
12,000
cancers
300,000 HSIL
1.25 million LSIL
2-3 million ASC
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
Pap Specimen Adequacy Depends on Obtaining
Both Ectocervical and Endocervical Cells
Sources of Errors with Conventional Pap
 Sampling errors
 Cells not collected on sampling device
 Collected cells not transferred to slide
 Cells poorly preserved
 Screening errors
 Cytologist misses abnormal cells
 Incorrect 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 sensitivity
 Reduces false negatives by 26%
 Improved specificity
 Reduction 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 Cytology
Trial Objective
To demonstrate equivalency of
cervical cytology sampling
using SoftPAP to conventional
spatula/brush for cervical CA
screening (Pap, HPV testing)
Patient Population
Methods
703 colposcopy clinic patients
Randomized collection of cervical
cytology specimens (compared
for Pap, HPV testing)
•specimen adequacy
•sensitivity
•specificity
Study Endpoints
SoftPAP® Results: Specimen Adequacy
SoftPAP® Results : Efficacy
* p <0.001
HPV vs. Cytology Correlation
Spatula/Brush
SoftPAP®
N
HPV
NEG
HPV
POS
N
WNL1
53
66%
34%
58 67.2% 32.8%
ASCLSIL2
173 32.4% 67.6% 136 28.7% 71.3% 309 30.7% 69.3%
HSIL
-CA3
68
2.9%
97.1%
43
HPV
NEG
0%
1 Within Normal Limits
2 Includes ASCUS, ASC-H, AGUS and LSIL
3 Includes HSIL, CIS and Cancer
HPV
POS
Total
100%
N
HPV
NEG
HPV
POS
111
66.7%
33.3%
111
1.8%
98.2%
SoftPAP® Study Conclusions
SoftPAP® is at least equivalent to spatula/brush for
the collection of samples for detection of cervical
dysplasia , cancer and high risk HPV
SoftPAP® may offer a lower false positive and lower
false negative rate than does spatula/brush
combination
-33% reduction in false positives; 26% reduction in false
negatives
Pinkerton, Guido, Ackerman, et al. Int J Obstet Gynecol, submitted 2009