Market availability of the PCA3-based test

In 2003, DiagnoCure signed a license and collaboration agreement with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second generation of the PCA3 test on Gen-Probe’s proprietary platform. According to the terms of this agreement, Gen-Probe received exclusive worldwide rights on the diagnostic products and will pay to DiagnoCure royalties on the cumulative net sales of the PCA3 assay to the end user.

In December 2005, Gen-Probe’s PCA3 analyte specific reagents (ASRs) were made available to selected laboratories in the U.S. and, in Spring 2006, AmeriPath and Bostwick Laboratories officially launched their versions of a PCA3-based test using reagents manufactured by Gen-Probe. The test is now available from most large laboratories in the U.S., who use PCA3 ASRs manufactured by Gen-Probe. Moreover, in August 2009, Gen-Probe announced that it had initiated a clinical study on 500 patients designed to obtain regulatory approval from the FDA that will allow the Company to fully commercialize the PCA3 test in the United States.

At the end of 2006, Gen-Probe also completed the first phase of the European launch of its CE-marked PROGENSA® PCA3 for prostate cancer. The test is currently available from over 30 laboratories in Europe.

U.S. laboratories

The PCA3 test is not approved for marketing in the U.S. The following laboratories have validated and offer a PCA3-based test using specific reagents manufactured by Gen-Probe.

Canadian laboratories

The following laboratories offer Gen-Probe's PCA3 test.

European laboratories

The following are some of the laboratories that offer the CE-marked Gen-Probe’s PROGENSA® PCA3 test. For a full list, please go to www.pca3.org.