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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<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 />
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