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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

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