Shuwen Biotech (Deqing, China), a diagnostic company focused on developing diagnostic kits and services for unmet clinical needs in China, has has formed an alliance with the Canada-based DiagnoCure (Québec) to commercialize the Previstage GCC colorectal cancer staging test in China.
Under the exclusive license and collaboration agreement, DiagnoCure has granted Shuwen Biotech an exclusive license to commercialize the Previstage GCC colorectal cancer staging test in the Greater China Region (China, Hong Kong, and Taiwan). Shuwen will conduct clinical trials in China on an IVD kit format of the Previstage test, and obtain a regulatory approval from the Chinese FDA for the kit. Shuwen will manufacture the IVD kit in its own manufacturing facilities and market the kit to major Chinese hospitals. In addition, Shuwen will also offer the Previstage testing service from its own clinical reference lab.
DiagnoCure develops cancer diagnostic tests. In 2008, the company launched a colorectal cancer staging test through its U.S. CLIA laboratory. Previstage GCC is currently available for licensing. The company has granted a worldwide exclusive license on the diagnostic applications of its proprietary molecular biomarker PCA3 to Gen-Probe, now a subsidiary of Hologic (Bedford, Massachusetts). Hologic Gen-Probe's Progensa PCA3 prostate cancer test is commercialized in Europe under CE mark and is approved for commercialization in Canada and the U.S.