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 made a first payment of US$3 million and agreed to make additional payments of US$6.0 million over the ensuing three years. Gen-Probe received exclusive worldwide rights on the diagnostic products resulting from this agreement and will pay to DiagnoCure royalties on the cumulative net sales of the PCA3 assay to the end user of 8% on the first $50 million and 16% on the excess.

In December 2005, Gen-Probe’s PCA3 analyte specific reagents were made available to selected laboratories in the U.S. and, in Spring 2006, AmeriPath, in conjunction with Molecular Profiling Institute, and Bostwick Laboratories officially launched their versions of a PCA3-based test using reagents manufactured by Gen-Probe. Other laboratories are being added.

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 in six laboratory sites across Europe. Additional laboratories will be distributing the test in subsequent launches over the coming months.

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 laboratories offer the CE-marked Gen-Probe’s PROGENSA™ PCA3 test.