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QIAGEN- Development Programs in HPV Testing A Special Focus

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<strong>HPV</strong> Genotyp<strong>in</strong>g’s Cl<strong>in</strong>ical Utility<br />

Framed by 3 Facts About <strong>HPV</strong> Infections<br />

Normal Cervix<br />

Infection<br />

Progression<br />

Invasion<br />

Clearance<br />

65 – 70%<br />

<strong>HPV</strong> Infected Cervix<br />

Regression<br />

Pre-Cancer<br />

Cancer<br />

<strong>HPV</strong> Genotyp<strong>in</strong>g: Develop a triage assay for risk of progression <strong>in</strong> women<br />

who present as Cytology Normal, <strong>HPV</strong> DNA+<br />

CIN = Cervical Intraepithelial Neoplasia<br />

<strong>QIAGEN</strong> Analyst and Investor Day, February 14, 2008<br />

Sample & Assay Technologies<br />

<strong>QIAGEN</strong> <strong>HPV</strong> Genotyp<strong>in</strong>g Test Strategy<br />

Positive HC2<br />

Genotyp<strong>in</strong>g<br />

Reflex<br />

QIAplex<br />

18 High Risk Types<br />

2 Low Risk Types<br />

QIAplex <strong>HPV</strong> Genotyp<strong>in</strong>g Assay<br />

• 1° Customers: Reference Labs<br />

• Genotype 18 High Risk and 2 low<br />

risk types<br />

• Initial Cl<strong>in</strong>ical utility: 16, 18 triage<br />

• Persistence for other HR types<br />

• Vacc<strong>in</strong>e monitor<strong>in</strong>g<br />

• GP 5+/6+ consensus primers<br />

• Lum<strong>in</strong>ex-based<br />

Ensemble<br />

High Risk: 16, 18<br />

(More possible)<br />

Probe Set Genotyp<strong>in</strong>g Assay<br />

• Run on Ensemble <strong>in</strong>strument<br />

• Genotype 16, 18+ x” Hybrid Capture<br />

format<br />

• Hybrid Capture format<br />

• Cytology labs: no PCR capability<br />

• Reagents: reflex on <strong>in</strong>strument<br />

<strong>QIAGEN</strong> Analyst and Investor Day, February 14, 2008<br />

-18-<br />

-19-<br />

Sample & Assay Technologies<br />

9

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