Gen-Probe: Another Setback for Ultrio (GPRO)

Gen-Probe (ticker: GPRO) announced that the FDA has advised the company of additional questions regarding the BLA for Procleix Ultrio for the simultaneous detection of HIV, hepatitis B and hepatitis C on eSAS; as a result, approval is most likely pushed out from year end to mid-2006. Earlier this month, the FDA also delayed approval of Ultrio on fully-automated Tigris system. We should receive more clarity on these issues on the November 2nd earnings call.

The Ultrio setback affects perception more than earnings. This is an otherwise modest setback for a company with strong growth: Ultrio continues to show strong sales trends ex-U.S.; west nile virus test should be approved next year; and the company has interesting tests in the pipeline for prostate cancer (PCA3) and HPV.

There may also be some implications of Novartis' (ticker: NVS) acquisition of Chiron (ticker: CHIR). Novartis may be forced to sell-off Chiron's blood screening business since they own 33% of Roche, which is the world market leader in blood screening.

GPRO chart.

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