Hologic thinprep 2000 - Summary of Direct-To-Vial HSIL+ Study; Direct-To-Vial HSIL+ Study; Summary of Direct-To-Vial Endocervical Component (ECC) Studies

MAN-02624-001 Rev. 003 page 13 of 15
Table 16: Summary of Direct-to-vial Endocervical Component (ECC) Studies
Study Number of
Evaluable
Patients
SBLB due to No
Endocervical
Component
Comparable
Conventional Pap
Smear Percentage
Direct-to-Vial
Feasibility
299 9.36% 9.43%
1
Direct-to-Vial
Clinical Study
484 4.96% 4.38%
2
1. Direct-to-Vial Feasibility study compared to overall clinical investigation conventional Pap
smear SBLB-No Endocervical Component rate.
2. Direct-to-Vial Clinical study compared to site S2 clinical investigation conventional Pap smear
SBLB-No Endocervical Component rate.
DIRECT-TO-VIAL HSIL+ STUDY
Following initial FDA approval of the ThinPrep System, Hologic conducted a multi-site direct-to-vial
clinical study to evaluate the ThinPrep 2000 System versus conventional Pap smear for the detection of
High Grade Squamous Intraepithelial and more severe lesions (HSIL+). Two types of patient groups
were enrolled in the trial from ten (10) leading academic hospitals in major metropolitan areas
throughout the United States. From each site, one group consisted of patients representative of a
routine Pap test screening population and the other group made up of patients representative of a
referral population enrolled at the time of colposcopic examination. The ThinPrep specimens were
collected prospectively and compared against a historical control cohort. The historical cohort
consisted of data collected from the same clinics and clinicians (if available) used to collect the
ThinPrep specimens. These data were collected sequentially from patients seen immediately prior to
the initiation of the study.
The results from this study showed a detection rate of 511 / 20,917 for the conventional Pap smear
versus 399 / 10,226 for the ThinPrep slides. For these clinical sites and these study populations, this
indicates a 59.7% increase in detection of HSIL+ lesions for the ThinPrep specimens. These results
are summarized in Table 17.
Table 17: Summary of Direct-to-Vial HSIL+ Study
Site
Total CP
(n) HSIL+
Percent
(%)
Total TP
(n) HSIL+
Percent
(%)
Percent
Change (%)
S1
2,439 51 2.1 1,218 26 2.1
+2.1
S2
2,075 44 2.1 1,001 57 5.7
+168.5
S3
2,034 7 0.3 1,016 16 1.6
+357.6
S4
2,043 14 0.7 1,000 19 1.9
+177.3
S5
2,040 166 8.1 1,004 98 9.8
+20.0
S6
2,011 37 1.8 1,004 39 3.9
+111.1
S7
2,221 58 2.6 1,000 45 4.5
+72.3
S8
2,039 61 3.0 983 44 4.5
+49.6
S9
2,000 4 0.2 1,000 5 0.5
+150.0
S10
2,015 69 3.4 1,000 50 5.0
+46.0
Total
20,917 511 2.4 10,226 399 3.9
59.7( p<0.001)
Percent Change (%) = ((TP HSIL+/TP Total)/(CP HSIL+/CP Total)-1) *100