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DiagnoCure Licenses Multi-Marker CRC Staging Test to China's Shuwen Biotech

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NEW YORK (GenomeWeb) — Canadian cancer diagnostics firm DiagnoCure said this week that it has granted an exclusive license to China's Shuwen Biotech to commercialize DiagnoCure's Previstage GCC colorectal cancer staging test in China, Hong Kong, and Taiwan.

The agreement includes a "clear commercial development plan in which both corporations are committed to close collaboration that is expected to lead to the expansion of the clinical use of the test," DiagnoCure said in a statement.

Because similar discussions are underway with third parties, DiagnoCure did not disclose details of the financial terms of the agreement.

The Previstage GCC colorectal cancer staging test uses quantitative reverse transcription to amplify minute quantities of GCC (GUCY2C) messenger RNA to magnify the presence of cancer cells.

According to the company, the current standard method for identifying metastasis in the lymph nodes involves microscopic examination of a thin slice of tissue from the lymph nodes harvested during a patient's surgery. This slice amounts to less than 1 percent of a lymph node's volume, and the microscopic examination has a detection sensitivity of one cancer cell in every 200 normal cells.

"Unfortunately, with this method, up to 20 percent of patients thought to have disease confined to the colon (stage I or II) return later with recurrent disease, presumably through cancer cells that were missed during microscopic examination," the company explains on its website. In contrast, Previstage can detect as few as one cancer cell among up to 10 million normal cells, and examines an average of 375 times more nodal tissue, according to the company.

DiagnoCure also said this week that a clinical study of the Previstage test is progressing and is expected to be completed by September.

DiagnoCure, based in Quebec City, develops molecular diagnostic assays for the detection and management of cancer. Its flagship molecular assay is the urine-based PCA3 test for prostate cancer. In 2003 DiagnoCure signed a license and collaboration agreement with Gen-Probe (now part of Hologic) for the development and commercialization of a second generation of the PCA3 test on Gen-Probe's Direct Tube Sampling system.

That assay, which uses isothermal transcription-mediated amplification, has been well-validated, but the company believes that sales of the assay are not as robust as they could be due to the fact that they run on an outdated instrument platform and not Hologic's Panther molecular testing system, DiagnoCure Chief Medical Officer Yves Fradet told PCR Insider in March.

DiagnoCure's second quarter earnings, also released this week, seem to support that assertion. For the three months ended April 30, DiagnoCure garnered total revenues of about $130,000 compared with $164,000 in the same period in 2013.

The decrease, DiagnoCure said, is attributable to PCA3 royalties, reflecting a reduction of 32 percent in US royalty revenues and an increase of 1 percent in European royalty revenues from the year-ago quarter.

"While the commercial advancement of the PCA3 test remains a concern for DiagnoCure, the clinical community continues to advocate the use of the test in the management and diagnosis of prostate cancer," the company said in a statement this week.

For example, the company said, the US National Comprehensive Cancer Network (NCCN) recently recognized the utility and specificity of the PCA3 test in predicting biopsy outcomes, recommending the assay in its recently updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection.

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