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Diagnocure Acquires Exclusive Worldwide Rights to Gene-Based Tests for Colorectal Cancer

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DiagnoCure strengthens its position in cancer diagnostics by securing exclusive worldwide rights to two high-value molecular tests for colorectal cancer and an option to a CLIA-certified U.S. service laboratory to commercialize molecular cancer diagnostics tests.

The two tests for colorectal cancer in-licensed from Targeted Diagnostics & Therapeutics, Inc., (TDT) of Philadelphia, PA, are based on the detection of GCC (guanylyl cyclase C), a gene that appears normally in cells lining the intestinal track, but has only been found outside the intestine when colorectal cancer has metastasized.

Initial research conducted by Dr. Scott A. Waldman of Thomas Jefferson University of Philadelphia, PA, showed GCC to be 95% to 100% accurate in detecting the spread or recurrence of colon cancer, in lymph nodes or blood. This led the National Institutes of Health (NIH) to provide more than $10 million in funding for two five-year multicenter clinical studies on 2,500 colorectal cancer patients.

Interim results from the NIH-sponsored GCC lymph node study started in 2003 are expected later this year.

“Preliminary data from the lymph node GCC study corroborated our initial research results,” said Dr. Waldman, founder of TDT.

“This agreement with TDT significantly strengthens our position in molecular diagnostics for cancer”, John Schafer, President and CEO of DiagnoCure said.

“We have just obtained what we believe to be the most promising tests for colorectal cancer. With these tests and our PCA3 biomarker for prostate cancer we now have high-value diagnostic tests for two of the top four most deadly forms of cancer,” Schafer added.

“With DiagnoCure securing the GCC-based tests, we are assured of the continued development and commercialisation of our tests for colorectal cancer,” Harry Arena, President and CEO of TDT mentioned. DiagnoCure has the proven track record in molecular diagnostics for cancer, the skills and the financial strength to expedite this process.

“Having a CLIA lab will enable us to quickly bring to market high-value molecular diagnostic tests for cancer in the home brew format,” Mr. Schafer explained.

While the total value of the transaction will not be disclosed, DiagnoCure's initial payment includes US$2.2 million in shares, each valued at CA$4.30. TDT will also receive performance-based milestone payments and royalties on revenues generated by the tests.

More than 150,000 Americans are diagnosed with colorectal cancer each year, with a post-surgery recurrence rate close to 50 percent. About 53,000 Americans die of the disease annually, making it the second leading cause of cancer-related deaths.