QUEBEC CITY, May 1st /PRNewswire-FirstCall/ - DiagnoCure strengthens its leading 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."
"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.
"We believe molecular diagnostics has the power to dramatically alter the way cancer is diagnosed and managed, and we have focused DiagnoCure squarely into this market. While the entire $24 billion diagnostics market is growing at just over 5% percent annually, cancer molecular diagnostics is growing faster than 30 percent," Mr. Schafer told shareholders at the Company's Annual General Meeting last month. "This is the first of what we expect will be several strategic acquisitions to strengthen our leadership position in this field."
Conference call Wednesday
Mr. Schafer and members of his management team will talk with investors via conference call at 10:00 AM Eastern Daylight time, Wednesday, May 2, 2007. To access the audio conference in real-time, please dial 1-800-590-1508.
About DiagnoCure
DiagnoCure specializes in the development, production and commercialization of molecular diagnostics for the detection and management of cancer. Its first test, ImmunoCyt(TM) / uCyt+(TM) for bladder cancer, is distributed worldwide. In 2003, the Company entered into a strategic alliance with Gen-Probe for the development and commercialization of a second-generation PCA3-based diagnostic test for prostate cancer. This test is now available in the U.S. through laboratories using PCA3 analyte specific reagents (ASR), as well as in Europe as the CE-marked Gen-Probe PROGENSATM PCA3 in vitro assay. In addition to its own research, the Company intends to acquire or in-license promising cancer biomarkers from both academic and commercial institutions. Additional information can be found at www.diagnocure.com.
About Targeted Diagnostics & Therapeutics, Inc.
TDT is a biotechnology company developing molecular-based technologies for the targeted detection, diagnosis and treatment of gastrointestinal cancers and infectious diseases. In August of 2003, TDT launched the first of several in vitro diagnostic products for the detection of metastatic colorectal cancer. The GCC-B1TM Blood Test is used for monitoring patients for signs of recurrent colorectal cancer. The GCC-N1TM Node Test is a lymph node test for staging colorectal cancer. Both tests can detect one colorectal cancer cell in 10,000,000 normal cells, and represent a dramatic improvement in sensitivity and specificity over other test methodologies currently in use. TDT has a rich pipeline of technologies with a number of additional product applications for the detection and treatment of several cancers, as well as therapies which could lead to a cure for colon cancer. TDT's headquarters and clinical laboratory for patient testing services are located in Philadelphia, Pennsylvania.
Forward-looking statements
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
DIAGNOCURE INC.CONTACT: Thom Skinner, Chief Financial Officer, DiagnoCure Inc., (418)527-6100, communications@diagnocure.com; Harry Arena, President and CEO,Targeted Diagnostics & Therapeutics, Inc., (610) 431-0800, ext. 203,arena@tdtinc.com
