QIAGEN- Development Programs in HPV Testing A Special Focus
QIAGEN- Development Programs in HPV Testing A Special Focus
QIAGEN- Development Programs in HPV Testing A Special Focus
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First Cl<strong>in</strong>ical-Endpo<strong>in</strong>t Trial: Ch<strong>in</strong>a, Jun 2007<br />
• Wu Xiang County (n = 2380)<br />
Fast<strong>HPV</strong> performance <strong>in</strong> predict<strong>in</strong>g cervical disease<br />
• Fast<strong>HPV</strong> test<strong>in</strong>g performed same day on-site<br />
• Test<strong>in</strong>g performed by locally tra<strong>in</strong>ed personnel<br />
• Reference hc2 test<strong>in</strong>g performed two weeks later <strong>in</strong><br />
advanced cl<strong>in</strong>ical lab <strong>in</strong> Beij<strong>in</strong>g<br />
•All women test<strong>in</strong>g positive followed up with appropriate<br />
cl<strong>in</strong>ical management…the same day<br />
Test<br />
hc2<br />
Fast<strong>HPV</strong><br />
VIA<br />
Cl<strong>in</strong>ical Sensitivity<br />
95%<br />
86%<br />
55%<br />
Cl<strong>in</strong>ical Specificity<br />
84%<br />
86%<br />
94%<br />
Fast<strong>HPV</strong> could reduce <strong>in</strong>cidence of cervical cancer by as much as 56%<br />
<strong>QIAGEN</strong> Analyst and Investor Day, February 14, 2008<br />
Sample & Assay Technologies<br />
The Status of FASThpv<br />
• Cl<strong>in</strong>ical studies demonstrate:<br />
FASThpv test produces rapid, accurate results<br />
FASThpv is simple to run and requires m<strong>in</strong>imal <strong>in</strong>frastructure<br />
• The test will be cost-effective to governments and NGO’s for<br />
public-health programs <strong>in</strong> qualify<strong>in</strong>g countries.<br />
• Mov<strong>in</strong>g quickly to leverage <strong>QIAGEN</strong>’s Ch<strong>in</strong>a-based <strong>in</strong>dustry<br />
lead<strong>in</strong>g molecular diagnostic organization to successfully<br />
manufacture, cl<strong>in</strong>ically validate and launch the Fast<strong>HPV</strong> test <strong>in</strong><br />
Ch<strong>in</strong>a.<br />
• The product is scheduled to be registered for approval <strong>in</strong> Ch<strong>in</strong>a<br />
<strong>in</strong> H1 2009.<br />
• Plann<strong>in</strong>g to follow our launch <strong>in</strong> Ch<strong>in</strong>a with similar efforts <strong>in</strong> India<br />
<strong>QIAGEN</strong> Analyst and Investor Day, February 14, 2008<br />
-26-<br />
-27-<br />
Sample & Assay Technologies<br />
13