TaqScreen West Nile Virus Program Roche Update

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TaqScreen West Nile Virus Program - Roche Update

• James L. Gallarda, Ph.D.
• Roche Molecular Diagnostics

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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

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First Fully Automated System in North America -
TaqScreen WNV
COBAS TaqMan
Hamilton Pipettor
COBAS AmpliPrep
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Non-Clinical Performance Studies Capacity
Analysis
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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

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

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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.

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Limit of detection studies with CDC WNV lysate
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Analytical sensitivity studies with IMPATH/BCP
WNV Lineage 1 isolate

• 95 LOD estimated to be lt 5 copies/mL

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Analytical sensitivity studies with BBI WNV
Lineage 2 (QWN701) Isolate

• 95 LOD (PROBIT) 7.41 copies/mL (95 CI 4.78
  16.13)

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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
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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.

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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

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