Hologic ThinPrep 5000 Instruction Manual page 15

Table 16: Summary of Direct-to-vial Endocervical Component (ECC) Studies
Study
Direct-to-Vial
Feasibility
Direct-to-Vial
Clinical Study
1. Direct-to-Vial
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
Total
Site CP (n)
S1
2,439
S2
2,075
S3
2,034
S4
2,043
S5
2,040
S6
2,011
S7
2,221
S8
2,039
S9
2,000
S10
2,015
Total
20,917
Percent Change (%) = ((TP HSIL+/TP Total)/(CP HSIL+/CP Total)-1) *100
Number of SBLB due to
Evaluable No Endocervical
Patients Component
299
484
Feasibility study compared to overall clinical investigation
Percent Total
HSIL+ (%) TP (n)
51 2.1 1,218
44 2.1 1,001
7 0.3 1,016
14 0.7 1,000
166 8.1 1,004
37 1.8 1,004
58 2.6 1,000
61 3.0
4 0.2 1,000
69 3.4 1,000
511 2.4 10,226
Comparable
Conventional Pap
Smear Percentage
9.36%
4.96%
Percent
HSIL+
(%)
26 2.1
57 5.7
16 1.6
19 1.9
98 9.8
39 3.9
45 4.5
983 44 4.5
5 0.5
50 5.0
399 3.9
MAN-04008-001 Rev. 001
1
9.43%
2
4.38%
Percent
Change (%)
+2.1
+168.5
+357.6
+177.3
+20.0
+111.1
+72.3
+49.6
+150.0
+46.0
59.7(p<0.001)
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