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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

TaqScreen West Nile Virus Program - Roche Update

James L. Gallarda, Ph.D.

Roche Molecular Diagnostics

PCR NAT Blood Screening

critical milestones update from march bpac
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

first fully automated system in north america taqscreen wnv
First Fully Automated System in North America - TaqScreen™ WNV

Hamilton Pipettor

COBAS TaqMan

COBAS AmpliPrep

PCR NAT Blood Screening

non clinical performance studies
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

clinical specificity 400 random volunteer samples from wnv low and high prevalence areas
Clinical specificity - 400 random volunteer samples from WNV low- and high- prevalence areas

PCR NAT Blood Screening

analytical specificity studies with non wnv microorganisms
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

analytical specificity studies with non wnv microorganisms8
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

analytical sensitivity studies with impath bcp wnv lineage 1 isolate
Analytical sensitivity studies with IMPATH/BCP WNV Lineage 1 isolate*

95% LOD estimated to be < 5 copies/mL

PCR NAT Blood Screening

analytical sensitivity studies with bbi wnv lineage 2 qwn701 isolate
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

reactivity to japanese encephalitis serocomplex members
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

phase i capacity analysis gulf coast regional blood center
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

current status issues
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

slide15

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