/NOT FOR DISTRIBUTION TO UNITED STATES NEWS SERVICES/
/THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES/
-ColonSentry(TM) data featured in International Journal of Cancer paper and editorial-
-Retains Reedland Capital Partners and Dundee Securities Inc.-
TORONTO, Feb. 9 /CNW/ - GeneNews Limited (TSX: GEN), an emerging molecular diagnostics and personalized health management company, today provided an update on corporate initiatives and the commercialization of the Company's lead product ColonSentry(TM), the world's first blood test for colorectal cancer.
GeneNews' innovative blood-based platform technology, the Sentinel Principle(R), which forms the basis of the ColonSentry(TM) test, is currently featured in an editorial found in the International Journal of Cancer (Volume 126, Issue 5, March 1, 2010). The paper which reports on the clinical validation data for ColonSentry(TM) appears in the same issue.
"As reported in the International Journal of Cancer, the analysis includes a total of 314 cancer samples in training and test set populations resulting from more than 10,000 patient samples collected from 25 screening colonoscopy and surgery clinics in North America, and represents one of the largest, if not the largest, colorectal cancer patient groups in a blood-based prospective study thus facilitating a well-controlled design,'' said Dr. Bernard Levin, Chair of GeneNews' Colorectal Cancer Clinical Advisory Board. "The reported data sets provide a solid basis for the Company's ColonSentry(TM) test which offers patients a blood-based testing option and thus has the potential to facilitate greater adherence to colorectal cancer screening guidelines." The editorial and paper entitled, "A Blood-Based Biomarker Panel for Stratifying Current Risk for Colorectal Cancer," are currently available online at: http://www3.interscience.wiley.com/journal/123226630/issue.
"Throughout 2009, we achieved several important corporate and commercialization milestones, including the execution of a strategic marketing partnership with our first regional U.S. commercialization partner for ColonSentry(TM), Enzo Clinical Labs Inc., a subsidiary of Enzo Biochem, and the issuance of our first U.S. foundational patent for our core platform technology, the Sentinel Principle(R)," said Gailina J. Liew, President & Chief Operating Officer of GeneNews. "Our efforts were supported by a strong investor base that stepped forward to provide an aggregate of $7.5 million in working capital over the past 14 months. We are appreciative of their demonstrated commitment which leaves us well-positioned as we look forward to 2010 and continue to build upon the positive momentum from our recent achievements."
The Sentinel Principle(R), a platform technology developed, owned and patented by GeneNews, is based on the concept that all health conditions and body states, including those resulting from disease or in response to treatment, generate characteristic gene expression signatures in a person's blood as a result of the close physiological interaction of blood with the cells, tissues and organs of the human body. U.S. Patent No. 7,598,031, issued to the Company on October 6, 2009, and entitled "Method for the detection of gene transcripts in blood and uses thereof," protects the Sentinel Principle(R). The Sentinel Principle(R) is a powerful method for identifying biomarkers from whole blood relating to any disease or health condition. This technology is the basis of GeneNews' first commercialized product, ColonSentry(TM), the world's first blood test for colorectal cancer. ColonSentry(TM) was commercially launched by GeneNews in Toronto, Canada, in July 2008, and is the first example of a clinical test developed from the Sentinel Principle(R).
In 2009, GeneNews presented the results of an health economic analysis of the ColonSentry(TM) test to facilitate screening for colorectal cancer. This health economic study, entitled, "The Cost-Effectiveness of a Blood Test for Colorectal Cancer Screening", demonstrated that the use of the ColonSentry(TM) test as a first step to triage average-risk patients followed by colonoscopy detected more early-stage colorectal cancers ("CRC"), thereby potentially reducing mortality attributable to CRC, and lowered the costs associated with late-stage CRC treatment compared to use of the fecal occult blood test (FOBT) or no screening. GeneNews also expanded the number of ColonSentry(TM) specimen collection services centres that are available in Ontario through Gamma-Dynacare Medical Laboratories, a leading provider of laboratory services, information and products in Canada. The Company also announced a commitment by the Malaysian Ministry of Health to provide the Company with a grant of MYR 5 million (approximately $1.55 million) to support a two-year joint project to expand the Company's pipeline of products to include the development of blood-based diagnostic tests for liver cancer and hepatitis based on the application of the Company's Sentinel Principle(R) platform technology.
In December 2009, the Malaysian government granted BioNexus status to the Company's Malaysian subsidiary as it prepares for the commercial launch of ColonSentry(TM) in Malaysia. BioNexus status is a designation awarded to qualifying biotechnology companies, making them eligible for certain tax benefits and privileges otherwise not available within Malaysia. These privileges include: freedom of ownership (including intellectual property); freedom to source funds globally; and freedom to bring in knowledge workers. BioNexus status is an important factor in attracting capital to prepare for the commercialization of ColonSentry(TM) in Malaysia.
Outlook for 2010
Looking forward, the Company's upcoming anticipated milestones for 2010 include:
- the commercial launch of ColonSentry(TM) in New York and New Jersey
by GeneNews' exclusive partner for these U.S. states, Enzo Clinical
- continued efforts to further the adoption and use of ColonSentry(TM)
- the engagement of additional partners to establish a global
ColonSentry(TM) marketing and distribution network that will make
ColonSentry(TM) available to patients in Europe, China, Malaysia, and
regions of the United States not covered by GeneNews' agreement with
- the initiation of further clinical and economic studies to generate
additional data to support public and private health insurance
reimbursement, and clinical adoption of ColonSentry(TM) as a cost-
effective and patient-friendly first step to facilitate greater
adherence to colorectal cancer screening guidelines;
- partnering to advance further development of GeneNews' pipeline of
molecular products based upon the Sentinel Principle(R); and
- additional patent issuances to expand the scope of protection for the
Company's Sentinel Principle(R) platform technology to include all
aspects of personalized health management from early detection to
determining response to treatment, and to protect the use of
biomarkers derived from the application of the Sentinel Principle to
specific clinical applications.
"We also intend to expand our shareholder base in 2010 and access additional working capital to support the pursuit of our milestones. Although no terms for an offering of securities have yet been agreed upon, the Company has recently retained Dundee Securities Corporation, a Canadian-based investment dealer and Reedland Capital Partners, an institutional division of Financial West Investment Group, Inc., a US-based, SEC-registered broker-dealer, as our agents to assist us in these efforts," said Ms. Liew. "Our ColonSentry(TM) commercialization strategy is centred on the engagement of capable and experienced partners to establish a global marketing and distribution network for ColonSentry(TM), thereby reducing the overall capital and in-house sales and marketing requirements that would otherwise be required by GeneNews to make ColonSentry(TM) broadly available to patients around the world. This strategy will ultimately lead to what the Company expects will be a strong recurring revenue base for GeneNews from royalties resulting from ColonSentry(TM) sales by our partners. Our primary focus for 2010 is to ensure that we remain on track with the execution of this strategy."
GeneNews is an emerging molecular diagnostics company focused on the application of functional genomics to enable early diagnosis and personalized health management based on disease-specific biomarkers. The Company has patented its core platform technology, the Sentinel Principle(R), which has the power to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle(R) in major areas with unmet clinical needs such as cancer, cardiovascular disease, neurological disorders and arthritis. GeneNews has developed and commercialized its first clinical test based on its core platform technology, ColonSentry(TM), a blood-based test to assess an individual's risk for colorectal cancer. For more information on GeneNews and ColonSentry(TM), visit www.genenews.com and www.colonsentry.com.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
SOURCE GeneNews Limited
For further information: For further information: Gailina Liew, President & COO, Office: (905) 739-2036, Mobile: (416) 844-0649, email@example.com