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In the United States, Gen-Probe received
FDA marketing approval to run the PROCLEIX
ULTRIO assay on the Company’s
semi-automated platform during 2006. The
assay was approved to screen donated
blood for HIV-1 and HCV, and to detect
HBV. During 2007, Gen-Probe expects to
conduct a post-marketing study of the
assay to intercept HBV-infected blood
donations and gain a blood screening
claim for HBV in the United States.
Gen-Probe’s other blood screening priorities
for 2007 include launching the PROCLEIX
WNV assay on the TIGRIS system in
the United States, filing for FDA clearance
to run the PROCLEIX ULTRIO assay on the
TIGRIS system, and continuing to support
international adoption of the Company’s
innovative tests and instrumentation.
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Les Vanderbush, manufacturing process technician, operates a fill
machine for a component of the Company’s blood screening
assays.
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