for the hepatitis B virus (HBV). The FDA had previously approved the
assay to screen donated blood for HIV-1 and the hepatitis C virus
(HCV). The assay is now approved to screen donated blood, plasma,
organs and tissue for the three viruses in individual blood donations
or in pools of up to 16 blood samples. The assay may be run on the
enhanced semi-automated PROCLEIX system (eSAS) and on the fully
automated, high-throughput TIGRIS system.
-- PROCLEIX ULTRIO Study Results. On October 7, independent investigators
presented key results of the PROCLEIX ULTRIO post-marketing HBV "yield"
studies at the annual meeting of the AABB. A total of 3.7 million
blood donations were screened in the two studies. Approximately 54% of
the donations were tested in pools of 16 donations, 30% were tested in
pools of eight donations, and 16% were tested as individual donations.
The ULTRIO assay detected eight cases of HBV yield, with yield defined
as HBV-infected blood donations that were missed by serology screening.
These donations therefore could have been transfused if not for the use
of the ULTRIO assay. In addition, the ULTRIO assay had a specificity
of greater than 99.9% in both studies, meaning that it generated fewer
than 0.1% "false positive" results. Based in part on the results of
these studies, the FDA fully approved the assay as described above.
-- $250 Million Stock Repurchase Plan. On August 26, Gen-Probe announced
that its board of directors had authorized the repurchase of up to
$250 million of the Company's common stock over the two years following
adoption of the program. Under the plan, repurchases may occur from
time to time and at Gen-Probe's discretion, depending on ma
|SOURCE Gen-Probe Incorporated|
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