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TaqScreen West Nile Virus Program - Roche Update

TaqScreen West Nile Virus Program - Roche Update. James L. Gallarda, Ph.D. Roche Molecular Diagnostics. Critical Milestones (Update from March BPAC). IND filed - April 21, 2003 Approved to allow sites to begin as test of record Phase I Training, Installation (5 sites - US and Canada)

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TaqScreen West Nile Virus Program - Roche Update

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  1. TaqScreen West Nile Virus Program - Roche Update James L. Gallarda, Ph.D. Roche Molecular Diagnostics PCR NAT Blood Screening

  2. Critical Milestones (Update from March BPAC) • IND filed - April 21, 2003 • Approved to allow sites to begin as test of record • Phase I • Training, Installation (5 sites - US and Canada) • Initiated studies (completed May, 2003) • Unlinked studies focused on workflow, training • Phase II • Training, Installation (completed June 14) • Safety and effectiveness in detecting WNV PCR NAT Blood Screening

  3. First Fully Automated System in North America - TaqScreen™ WNV Hamilton Pipettor COBAS TaqMan COBAS AmpliPrep PCR NAT Blood Screening

  4. Non-Clinical Performance Studies & Capacity Analysis PCR NAT Blood Screening

  5. Non-Clinical Performance Studies • Clinical specificity - 400 random volunteer samples from WNV low- and high- prevalence areas • Analytical specificity studies with non-WNV microorganisms • Limit of detection studies with CDC WNV lysate • Analytical sensitivity studies with IMPATH/BCP WNV Lineage 1 isolate • Analytical sensitivity studies with BBI WNV Lineage 2 (QWN701) Isolate • Reactivity to Japanese encephalitis serocomplex members PCR NAT Blood Screening

  6. Clinical specificity - 400 random volunteer samples from WNV low- and high- prevalence areas PCR NAT Blood Screening

  7. Human T-cell leukemia virus (HTLV I/II) Hepatitis B virus (HBV) Human immunodeficiency virus Type I (HIV-1) Hepatitis C virus (HCV) Cytomegalovirus (CMV) Hepatitis A virus (HAV) Adenovirus Herpes simplex virus (HSV) Human papilloma virus (HPV) Varicella virus Chlamydia trachomatis Proprionibacterium acnes Staphylococcus aureus Staphylococcus epidermidis Neisseria gonorrhoeae Candida albicans Analytical specificity studies with non-WNV microorganisms PCR NAT Blood Screening

  8. Analytical specificity studies with non-WNV microorganisms • Each of the 125 samples positive for these microorganisms tested negative in the TaqScreen WNV assay - no false-positive test results were observed. All associated Armored Internal Controls were positive for each sample tested. PCR NAT Blood Screening

  9. Positive @ > 107 dilution Limit of detection studies with CDC WNV lysate PCR NAT Blood Screening

  10. Analytical sensitivity studies with IMPATH/BCP WNV Lineage 1 isolate* 95% LOD estimated to be < 5 copies/mL PCR NAT Blood Screening

  11. Analytical sensitivity studies with BBI WNV Lineage 2 (QWN701) Isolate* 95% LOD (PROBIT) = 7.41 copies/mL (95% CI: 4.78 – 16.13) PCR NAT Blood Screening

  12. Reactivity to Japanese Encephalitis serocomplex members • Additional WNV isolate (ATCC VR-1267) • St Louis encephalitis virus (ATCC VR-1265) • Murray Valley encephalitis virus (ATCC VR-77) All isolates detected PCR NAT Blood Screening

  13. Phase I Capacity Analysis(Gulf Coast Regional Blood Center) • Start pooling 0630 hrs (average pooling time 19.5 minutes) • First extractions on COBAS AmpliPrep begin 0649 hrs • First amplifications begin 0900 hrs • Total throughput with 2 FTE operating 2 systems = 1728 samples in 11 ½ hours • Conservative extrapolation (one shift of 8 hours with “reporting” in the last 3 ½ hours) estimates ~500,000 samples per 2 FTE operating 2 system per year. PCR NAT Blood Screening

  14. Current Status & Issues • All 11 US sites and 3 Canadian sites are installed and prepared for linked testing on or before July 1 • Potential expansion to other sites • Assisting public health lab diagnostic needs • Dissemination of prevalence data through REDS • USDA permit requirements to ship WNV panels • Standardization of WNV panel • Capital, training, and support costs are substantial to execute multi-site IND PCR NAT Blood Screening

  15. Roche Diagnostics - Commitment to West Nile Response Rotkreuz, SW Engineering Manufacturing Laval, Que, Canada Distribution Customer Support Regulatory Clinical Trial Support Branchburg & Belleville, NJ Manufacturing & Quality IT/SAP Penzberg, GmbH Development Regulatory Marketing Indianapolis, IN Distribution Customer Support Pleasanton, CA Development Marketing Regulatory/Clinical Finance & Admin. Alameda, CA Legal/Licensing Research Roche Genetics PCR NAT Blood Screening

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