Healthcare Industry News:  colorectal cancer 

Diagnostics Oncology Licensing

 News Release - June 5, 2007

EXACT Sciences and NorDiag Announce International Collaboration and License Agreement for Colorectal Cancer

MARLBOROUGH, Mass. & OSLO, Norway--(HSMN NewsFeed)--EXACT Sciences Corporation (NASDAQ: EXAS ) and NorDiag ASA (OSE: NORD) announced today that they have entered into a collaboration and a non-exclusive license agreement to advance the development and commercialization of colorectal cancer (CRC) screening technologies outside the U.S. and Canada. Under the terms of the agreement, EXACT Sciences has extended a non-exclusive license to its proprietary DIA® (long-DNA) technology and related know-how to NorDiag for commercializing CRC screening tests in Europe, Japan and Australia. The collaboration and license also includes the right to develop an in vitro diagnostic test kit as well for these markets. In exchange, NorDiag will pay a licensing fee and royalties to EXACT. Financial terms were not disclosed.

"This agreement fulfills one of our key corporate goals which is to expand our DNA-based colorectal cancer screening technologies into international markets where there is a tremendous need for new methods," said Don Hardison, President and CEO of EXACT Sciences. "We are pleased to have aligned ourselves with NorDiag abroad as they have a demonstrated ability to commercialize stool-based DNA diagnostics in markets outside the U.S. We are also looking forward to collaborating with NorDiag to explore ways in which we may further leverage each other's strengths, while continuing to advance stool-based DNA testing worldwide."

"We are very pleased to work with the leading U.S. company in molecular, stool-based screening for colorectal cancer," said Marten Wigstol, CEO of NorDiag. "Having access to their issued patents and expertise related to the long-DNA cancer biomarker will further enhance our colorectal cancer product strategy. EXACT's IP and know-how is complimentary to already in-licensed NorDiag Long-DNA technology and enables us to strengthen our technology base as we work toward the rapid development and launch of a cost-effective, test kit for CRC screening in Europe and Asia. This is an enormous market with room for many players - we believe that this is the start to a collaboration that can easily be expanded in the foreseeable future."

colorectal cancer mortality is a global problem. Worldwide there are more than 900,000 new cases diagnosed annually and with 500,000 deaths it is the second most deadly cancer. In Europe alone there are 100 million people over the age of 50 that should be screened for colorectal cancer and it is estimated that a third of CRC-related deaths could be prevented if more people underwent regular screening. New screening options such as those based on EXACT's and NorDiag's technologies can help address this problem and have the potential to increase screening rates for this deadly, but curable disease if caught early.

DIA (long-DNA) is a proprietary biomarker of EXACT Sciences that is used to identify, at the molecular level, the presence of abnormal cell death, which is typically a hallmark of cancer. When the marker is detected in stool samples of patients, multiple studies have shown both high sensitivity and specificity for the presence of colorectal cancer. The DIA biomarker is also a key component of the PreGen-Plus(TM) testing services currently offered by Laboratory Corporation of America®. It is also a key biomarker in EXACT Sciences' second generation technology, recently demonstrating sensitivity of 88% in a study published in Clinical Gastroenterology and Hepatology in January, 2007.

About EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. colorectal cancer, which is the most deadly cancer among non-smokers, is generally curable if detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high. EXACT Sciences believes its genomics-based technologies will help enable detection of colorectal cancer so that more people can be effectively treated. EXACT Sciences is based in Marlborough, Mass. PreGen-Plus(TM), the non-invasive colorectal cancer screening testing service offered by LabCorp, has not been approved or cleared by the Food & Drug Administration.

About NorDiag ASA

NorDiag is a biotechnology company with focus on genetic diagnostics in the fields of cancer and infectious diseases. The Company's first product in cancer diagnosis is Genefec(TM) for the diagnosis of colorectal cancer. The company has other applications for diagnosis of cancer under development, among others a screening product for colorectal cancer. In addition the company has a product for automated sample preparation of sexually transmitted diseases, as well as applications for other infectious diseases in the product pipeline. NorDiag is listed on Oslo Stock Exchange with the ticker NORD.

Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences' expectations concerning, among other things, the ability of EXACT Sciences to realized the expected benefits of its agreement with NorDiag, the efficacy of its colorectal cancer screening technology and management's plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences' control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; the inclusion of fecal DNA screening in colorectal cancer screening guidelines; sufficient investment in the sales and marketing of EXACT Sciences' technologies; the success of its strategic relationship with LabCorp; EXACT Sciences' ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' technologies; the ability to convince medical practitioners to order tests using EXACT Sciences' technologies; the ability to increase the performance of the PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower the cost of the PreGen-Plus test through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences' technologies; competition; the ability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences' public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the SEC.


Source: EXACT Sciences

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