 May Licensed from the University of Michigan the exclusive worldwide rights to develop diagnostic tests for recently discovered genetic translocations associated with prostate cancer.  June Agreed to settle patent disputes with Bayer. Bayer agreed to pay Gen-Probe approximately $32 million over three years if certain conditions are met. August Received US Food and Drug Administration (FDA) clearance to test two additional kinds of patient samples for chlamydia and gonorrhea with the APTIMA Combo 2® assay on the TIGRIS® system. October Received FDA license for the PROCLEIX® ULTRIO® assay to screen donated blood for HIV-1 and hepatitis C virus (HCV), and to detect the presence of hepatitis B virus (HBV). Announced plans to conduct a post-marketing study to demonstrate HBV yield and gain an associated donor-screening claim. Received FDA approval for the APTIMA® HIV-1 RNA qualitative assay for clinical diagnostic use. Received FDA clearance to run the standalone APTIMA tests for chlamydia and gonorrhea on the TIGRIS system. November Launched in Europe the CE-marked PROGENSA™ PCA3 assay, a new, highly specific gene-based test for prostate cancer. December Formed an exclusive worldwide collaboration with 3M to develop, manufacture and market innovative NATs to enhance food safety and increase the efficiency of testing for food manufacturers. |
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 Achieve growth in earnings per share and revenues consistent with financial guidance. Continue to increase market shares of key commercial products, including the APTIMA Combo 2 assay and the PROCLEIX ULTRIO assay, which is approved outside the United States to screen donated blood for HIV-1, HCV and HBV. Gain FDA approval to screen donated blood for West Nile virus on the TIGRIS system.¹ Conduct US post-marketing study of the PROCLEIX ULTRIO assay to demonstrate HBV yield. File for FDA approval to use the PROCLEIX ULTRIO assay on the TIGRIS system.² Generate initial commercial revenue from first Millipore product to detect contamination in biopharmaceutical production processes.
¹ FDA approval received in March 2007.
² Application submitted to FDA in January 2007. |