GeneNews - Press Release feed

GeneNews Rolls Out ColonSentry™ Test In Additional Toronto Area Labs

dboyd — Thu, 20 Nov 2008 13:35:40 -0600

Date: Wed, 2008-11-19 23:00

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GeneNews Limited (TSX: GEN), a company focused on developing blood based biomarker tests for the early detection of diseases and personalized health management, today announced that Gamma-Dynacare Medical Laboratories, leading providers of laboratory services, information and products in Canada, will provide blood specimen collection services for ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer, from an expanded number of laboratory patient service centres in the Toronto area.

"We are very pleased to be working with Gamma-Dynacare as it is one of Canada's largest and most respected providers of medical laboratory services. Gamma-Dynacare is committed to bringing the next generation of medical diagnostic tests to Canadians and ColonSentry™ will complement their menu of leading-edge offerings," said Gailina Liew, Chief Operating Officer of GeneNews. "The addition of these sites in the Toronto area will provide a far greater number of patients access to our unique test, an important factor as we continue to drive awareness and increase clinical and patient adoption of the ColonSentry™ test."

"Colorectal cancer is the second deadliest cancer in Canada, but is highly curable when detected early. The ColonSentry™ test represents a new approach to colorectal cancer screening that is more convenient for patients as the test only requires a simple blood sample," said Ron Hoffman, Vice-President, Business Development, Gamma-Dynacare Medical Laboratories. "We look forward to expanding access to the ColonSentry™ test in additional locations in south-western Ontario and Quebec over the next few months. We believe the convenience of this test will result in more patients being screened and we are proud to be the first community laboratory in Canada to assist GeneNews in the introduction of ColonSentry™."

"Gamma-Dynacare is currently offering specimen collection services for the ColonSentry™ test at the following eight Patient Service Centre locations that are listed below. GeneNews and Gamma-Dynacare expect to expand availability of ColonSentry™ to more Gamma-Dynacare locations in Ontario and Quebec over the first quarter of 2009."

1. 2401 Yonge St., Suite LL9 (Yonge St. & Eglinton Ave.)
Toronto, Ontario, M4P 3H1

Hours of operation:
Monday - Thursday
8:00 AM to 8:00 PM
Friday
8:00 AM to 3:00 PM

2. 123 Edward St., Suite 808 (University and Dundas)
Toronto, Ontario, M5G 1E2

Hours of operation:
Monday - Thursday
8:00 AM to 6:00 PM
Friday
8:00 AM to 3:00 PM

3. 328 Highway 7 East, Suite 210 (Bayview and Highway No.7)
Richmond Hill, Ontario, L4B 3P7

Hours of operation:
Monday - Thursday
8:00 AM to 5:00 PM
Friday
8:00 AM to 3:00 PM

4. 5359 Dundas Street West, Suite 200 (Bloor St. W. and Dundas St. W.)
Etobicoke, Ontario, M9B 6H8

Hours of operation:
Monday - Friday
9:00 AM to 12:00 PM

5. 960 Lawrence Avenue West, Suite 102 (Lawrence St. W. and Dufferin St.)
Toronto, Ontario, M6A 3B5

Hours of operation:
Monday - Thursday
8:00 AM to 6:00 PM
Friday
8:00 AM to 3:00 PM

6. 2000 Credit Valley Rd., Suite 107 (Credit Valley Road and Eglinton Ave W.)
Mississauga, ON L5M 4N4

Hours of operation:
Monday - Thursday
7:00 AM to 8:00 PM
Friday
7:00 AM to 3:00 PM

7. 164 Queen St. E., Main Floor (Queen St. East and Kennedy Road South)
Brampton, ON L6V 1B4

Hours of operation:
Monday - Thursday
7:00 AM to 5:00 PM
Friday:
8:00 AM to 3:00 PM

8. 95 Bayly Street West, Unit 208 (Bayly St. W. and Harwood Ave. S.)
Ajax, ON L1S 7K8

Hours of operation:
Monday, Tuesday and Thursday
8:00 AM to 7:00 PM
Wednesday
8:00 AM to 5:00 PM
Friday
8:00 AM to 3:00 PM

About Gamma-Dynacare Medical Laboratories
Gamma-Dynacare is one of Canada's largest and most respected providers of laboratory services and solutions. Our skilled and dedicated employees perform millions of tests each year in our state-of-the-art facilities, playing a key role in the treatment of patients and the prevention and diagnosis of disease. By living our mission of "Caring for People", we positively impact the health and wellness of people across Canada and are a valuable contributor to the betterment of the overall healthcare system. For additional information please visit www.gamma-dynacare.com

GeneNews Appoints Canadian Colorectal Cancer Advisory Board

dboyd — Wed, 19 Nov 2008 08:28:12 -0600

Date: Tue, 2008-11-18 22:00

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GeneNews Limited (TSX: GEN), a company focused on developing blood based biomarker tests for the early detection of diseases and personalized health management, today announced the formation of a Canadian Colorectal Cancer Advisory Board. Drs. Lawrence Cohen, Jeffrey Baker, Khursheed JeeJeebhoy, Andy Smith and Mr. Barry Stein will advise GeneNews on clinical and patient adoption strategies for the Canadian commercialization of ColonSentry™, the world's first blood-based screening test to determine a person's current risk for colorectal cancer.

"Following our July launch of ColonSentry™, we are increasing the availability of our test across the Greater Toronto Area and plan to expand into other regions of Canada through 2009," said Dr. Heiner Dreismann, Interim CEO and Lead Director of GeneNews. "This group of experts has been assisting us in delivering a series of physician education sessions on the need to engage in colorectal cancer screening and how increased compliance can ultimately save lives and potentially reduce the health economic burden. As we prepare to roll out our ColonSentry™ test across Canada, this advisory board will also provide invaluable region specific insights to allow us to most efficiently drive commercial adoption."

Dr. Lawrence Cohen

Dr. Cohen is the Director of and consultant in the Division of Gastroenterology and Chief of Medical Endoscopy at Sunnybrook Health Sciences Centre. He is an Associate Professor of Medicine at the University of Toronto and is a Fellow of the American College of Gastroenterology. Dr. Cohen received his Master of Science in Pharmacology at the University of Toronto and his Doctor of Medicine from McMaster University. He completed his Internal Medicine Fellowship at the University of Toronto with subspecialty training in Gastroenterology and Therapeutic Endoscopy.

Dr. Jeffrey Baker

Dr. Baker has been at St. Michael's Hospital since 1985 where he currently practices general gastroenterology with major interests in endoscopy, especially colonoscopy, inflammatory bowel disease and clinical nutrition. Dr. Baker graduated from the University of Toronto medical school and subsequently trained in internal medicine in Toronto and then gastroenterology at the Scripps Clinic and Research Foundation in La Jolla, California.

Dr. Khursheed Jeejeebhoy

Dr. Jeejeebhoy was the former division director of gastroenterology at the University of Toronto and the Toronto General Hospital and currently directs nutrition support and is a staff physician at St. Michael's Hospital. He is also a Emeritus Professor of Medicine, cross appointed to the Department of Nutritional Sciences at the University of Toronto. Dr. Jeejeebhoy received his medical degree from the Christian Medical College Hospital in Vellore, India and obtained his PhD from London University.

Dr. Andy Smith

Dr. Smith is a Surgical Oncologist at the Odette Cancer Centre, Head of the Division of General Surgery at Sunnybrook Health Sciences Centre and an Associate Professor at the University of Toronto. Dr. Smith completed medical school and General Surgery residency at the University of Toronto. During residency, he completed a Masters of Science studying the molecular biology of colorectal cancer.

Mr. Barry Stein

Mr. Stein is the President of the Colorectal Cancer Association of Canada (CCAC) and a survivor of metastatic colorectal cancer that was diagnosed in 1995. Mr. Stein graduated from McGill University faculties of Business Management and Law and he has been a member of the Bar of Quebec since 1981.

GeneNews Announces 2008 Third Quarter Results

dboyd — Mon, 17 Nov 2008 08:24:23 -0600

Date: Mon, 2008-11-17 14:00

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GeneNews Limited (TSX: GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today reported operational and financial results for the third quarter and year to date, ended September 30, 2008. The Company's lead product is ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer.

"Our recent restructuring has allowed us to leverage our strengths in Asia and should substantially reduce our overall use of capital in the near-term, while focusing our North American resources completely on the commercialization of ColonSentry™," said Dr. Heiner Dreismann, Lead Director and Interim CEO of GeneNews. "The next few months will be critical in the development and initial implementation of our U.S. marketing and reimbursement strategy as we plan to launch our ColonSentry™ test in the U.S. in the second half of 2009."

Subsequent to quarter-end the company restructured its operations. The Company's operations in Canada are now entirely focused on the Canadian and U.S. commercialization of its lead product, ColonSentry™. As a result, the Company's monthly cash expenditures in Canada will be significantly reduced on an ongoing basis commencing in 2009. Research and development of the Company's pipeline have been moved to GeneNews' Asian operations, which will also focus on the commercialization of ColonSentry™ in that region.

In support of the North American commercialization of ColonSentry™, in August GeneNews partnered with Scienta Health, a Toronto-based executive health clinic, to offer the ColonSentry™ test to its patients. GeneNews plans to partner with additional executive health clinics and expand the availability of ColonSentry™ beyond Ontario throughout 2009. The Company also appointed Patrick Terry as its lead strategic advisor for the U.S. commercial launch of ColonSentry™. Mr. Terry is one of the co-founders of Genomic Health and is a pioneer in the field of personalized medicine.

Financial results (CDN dollars) for the three-month and nine-month periods ended September 30, 2008:

Total revenue for the first quarter was $0.3 million (year-to-date: $0.9 million) compared to $0.2 million (year-to-date: $1.9 million) for the same period last year. Revenue in the third quarter resulted from a collaboration agreement entered into with an Asian biomedical consortium to identify and validate a set of biomarkers in the field of prostate diseases, for a total fee of $2 million (USD), while revenue in 2007 resulted from a collaboration agreement with Pfizer completed in the first fiscal quarter of 2007.

Total operating expenditures for the third quarter were $4.3 million (year-to-date: $11.6 million) compared with $3.4 million (year-to-date: $9.6 million) for the same periods last year. Research and development expenses in the third quarter were $2.6 million (year-to-date: $7.9 million) compared with $2.4 million (year-to-date: $6.8 million) for the same periods last year. General and administrative expenses for the third quarter were $0.7 million (year-to-date: $2.0 million) compared with $0.7 million (year-to-date: $2.0 million) for the corresponding periods in the previous year.

The net loss for the third quarter was $3.9 million or a loss of $0.07 per common share compared with a net loss of $3.0 million or a loss of $0.05 per common share for the same period last year. Year to date, the net loss was $10.5 million (2007: $7.0 million) or a loss of $0.19 (2007: $0.13) per common share. The net loss is reflective of the Company's continuing focus on research and development and product development which led, on July 21, 2008, to the launch of its first product, ColonSentry™, and the advancement of related products in the Company's pipeline.

As at September 30, 2008, the Company's cash and cash equivalents amounted to $3.2 million compared to $11.3 million as at December 31, 2007. As of November 6, 2008, approximately $1,668,000 in cash and cash equivalents was segregated as cash collateral, primarily resulting from the breach of a debt covenant. The Company is not in default on its payments of interest and principal and the bank has agreed to waive the covenant as the Company pursues additional funding opportunities. As at September 30, 2008 the Company had 56,207,176 common shares and 6,802,632 stock options outstanding.

Management's Discussion and Analysis of the financial statements for the three-month and nine month periods ended September 30, 2008 is available on SEDAR at www.sedar.com.

Attached file description:: Financial statements are available in the attached pdf document.

Attached file: 11 14 08 GEN Q3 08 Results FINAL.pdf (50.74 KB)

GeneNews Restructures Operations

dboyd — Wed, 12 Nov 2008 09:03:11 -0600

Date: Wed, 2008-11-12 06:00

Body:

North American resources focused on commercialization of ColonSentry™; Asian resources focused on pipeline development and local commercialization

GeneNews Limited (TSX: GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today announced that it has implemented a strategic restructuring of its North American and Asian operations. The Company's operation in Canada will focus on the Canadian and U.S. commercialization of its lead product, ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer. Research and development of the Company's pipeline, including patient sample accrual to support these activities, will be moved to GeneNews' Asian operations. As part of the restructuring, the Company has reduced its workforce in Canada by 40%.

"While these actions are difficult, when assessing the structure of our company and our strengths in Canada and Asia, we determined that there were efficiencies in research and development that could be better leveraged from our Asian operations in Penang, Malaysia and Tianjin, China," said Dr. Heiner Dreismann, Lead Director and Interim CEO of GeneNews. "Transferring this segment of our operations to our Asian facilities also enhances opportunities to access to capital from Asian sources, which GeneNews has successfully secured in the past, to support research and development activities including the accrual of patient samples to support our pipeline development. We will also be better positioned to attract resources and expertise to facilitate the commercial launch of our products in China, Malaysia and the surrounding regions."

Dr. Dreismann continued: "This restructuring will result in a substantial reduction in cash expenditures in Canada over the near term and allows us to completely refocus our North American sources on the commercialization of our lead ColonSentry™ product in Canada and the U.S. As we roll out our test in additional regions in Canada and prepare for its commercial launch in the U.S. in the second half of 2009, we believe that a leaner and more focused organization will provide a significant strategic advantage to GeneNews."

The Company will maintain its global headquarters in Canada where it will focus on Canadian marketing activities and development of a U.S. marketing and reimbursement strategy for the ColonSentry™ test. GeneNews will continue development and validation of the ColonSentry™ test to support a CLIA submission and the operation of a centralized clinical reference laboratory to serve the North American market from its global headquarters. Scientific leadership and direction for research and development activities that will be pursued by the Company's Asian facilities and the development of a strategy to create a personalized health management system based on the Sentinel Principle will also be managed in the Company's global headquarters.

GeneNews Appoints Patrick Terry as Lead Strategic Advisor for U.S Commercialization of ColonSentry™

dboyd — Wed, 15 Oct 2008 08:18:37 -0500

Date: Wed, 2008-10-15 04:00

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GeneNews Limited (TSX: GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today announced that it has appointed Patrick Terry as its lead strategic advisor for the U.S. commercial launch of ColonSentry™, the world’s first blood-based test to determine a person’s current risk for colorectal cancer. Mr. Terry is one of the co-founders of Genomic Health, a leading molecular diagnostics company.

“Having co-founded one of the most successful molecular diagnostic companies in the U.S., Mr. Terry is the ideal individual to advise GeneNews on its U.S. commercialization strategy,” said Dr. Heiner Dreismann, Interim CEO and Lead Director of GeneNews. “Mr. Terry is a pioneer in the field of personalized medicine. His experience growing Genomic Health from a start up to a company with $64 million in revenues will be invaluable as we prepare for U.S. commercialization of our ColonSentry™ test in 2009.” The Company launched its lead product, the ColonSentry™ test, in Canada earlier this year.

Mr. Terry is the co-founder and former Director of Consumer Advocacy & Governmental Affairs at Genomic Health. He is also co-founder and former President of the International Genetic Alliance, which focuses on empowering problem solving by networking the consumer movement, centers of excellence, and high technology with patient communities around the world. Mr. Terry has published dozens of peer-reviewed scientific papers, articles, and book chapters in the field of genetics, personalized medicine, and biomedical research. Some of his activities include leadership positions on numerous trade associations, professional societies, corporate boards, and he also sits on a number of U.S. federal advisory bodies.

GeneNews Partners with Leading Executive Health Clinic for Colonsentry™

psun — Tue, 12 Aug 2008 13:34:46 -0500

Date: Tue, 2008-08-12 06:00

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GeneNews Limited (TSX: GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, today announced that Scienta Health, a Toronto-based executive health clinic, will offer the ColonSentry™ test to its patients. ColonSentry is the world’s first blood based molecular test that assesses a patient’s current risk of having colorectal cancer and is the lead product in a planned suite of “Sentry” products based on the Sentinel Principle™ technology that GeneNews will bring to market. Scienta will offer the ColonSentry test to its clients as an optional component in their comprehensive annual health assessments.

“The ColonSentry test is a breakthrough risk-assessment tool that provides a more accurate and reliable basis for recommending colonoscopies than demographic benchmarks or the less sophisticated occult blood stool test. We believe that these traditional guidelines result in overlooked risk for the patient,” said Dr. Elaine Chin, Chief Medical Officer and co-founder of Scienta Health. “Alternatively, this patient-friendly blood test will provide diagnostic information to allow physicians to make better decisions regarding next steps in the colorectal cancer screening process. Ultimately, the ColonSentry™ test may help identify the presence of this cancer in patients at a curable stage providing individualized preventative health care for our patients, which is fundamental to Scienta’s core commitment to our patients.”

“Scienta is a leader in individualized preventive medicine and as the first executive health clinic to offer our ColonSentry test, their patients will now have access to this unique and powerful risk-assessment tool among their robust suite of health care services,” said Dr. Heiner Dreismann, interim CEO and Lead Director of GeneNews. “Our partnership with Scienta is a good example of one component in our commercialization strategy for ColonSentry. In the coming months, we expect to rollout our test in additional regions in Canada and target private health insurers to include our test under their healthcare offerings.” For more information on the ColonSentry test, please visit www.colonsentry.com.

Scienta Health specializes in individualized preventive medicine. The clinic is renowned for its expertise in applying the latest science to health screening and disease prevention. Scienta is the first executive health clinic to offer ColonSentry to its clients and the test will be an optional component in their comprehensive annual health assessments. For additional information please visit www.scientahealth.com.

GeneNews Announces Second Quarter Results

psun — Thu, 07 Aug 2008 11:42:36 -0500

Date: Thu, 2008-08-07 20:00

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“The launch of our first commercial product, ColonSentry™, a blood test to assess a patient’s current risk of having colorectal cancer, marks the completion of our Company’s transition into a fully commercial enterprise. ColonSentry is the world’s first blood test for colorectal cancer screening and we believe this unique product will facilitate earlier detection and treatment of the disease, resulting in improved outcomes for patients with colorectal cancer,” said Dr. Heiner Dreismann, Lead Director and Interim CEO of GeneNews. “Over the coming quarters, our focus will be on driving adoption of ColonSentry in Canada, subsequent launches of the test in Asia, the United States and Europe, and further development of our pipeline of innovative molecular diagnostic tests for a range of disease indications.”

Highlights in the second quarter:

Subsequent to quarter-end in July, launched the world’s first blood test for colorectal cancer screening in the Greater Toronto Area.
Presented positive results in a Late Breaking Abstract at the American Association of Cancer Research (AACR) annual meeting from a validation study of a panel of six colorectal cancer biomarkers, confirming (p<0.05) that the panel was able to stratify a population with average risk for colorectal cancer into three defined risk groups (Increased, Average, and Decreased Probability).
Elected two additional independent members to the Board of Directors, Mr. Harry A. Glorikian and Ms. Fran Tuttle.

Financial results (CDN dollars) for the three-month and six month periods ended June 30, 2008:

Total revenue for the first quarter was $0.3 million (year-to-date - $0.6) compared to $nil (year-to-date - $1.7 million) for the same periods last year. Revenue in the second quarter resulted from a collaboration agreement entered into with an Asian biomedical consortium to identify and validate a set of biomarkers in the field of prostate diseases, for a total fee of $2 million (USD), while revenue in 2007 resulted from a collaboration agreement with Pfizer completed in the first fiscal quarter of 2007.

Total operating expenditures for the second quarter were $4.3 million (year-to-date - $7.3 million) compared with $2.7 million (year-to-date - $6.2 million) for the same periods last year. Research and development expenses in the second quarter were $3.0 million (year-to-date - $5.2 million) compared with $1.8 million (year-to-date - $4.4 million) for the same periods last year. General and administrative expenses for the second quarter were $0.8 million (year-to-date - $1.3 million) compared with $0.6 million (year-to-date - $1.3) for the corresponding periods in the previous year.

The net loss for the second quarter was $4.0 million or a loss of $0.07 per common share compared with a net loss of $2.3 million or a loss of $0.04 per common share for the same period last year. Year to date, the net loss was $6.6 (2007 - $4.0) million or a loss of $0.12 (2007 - $0.07) per common share. The net loss is reflective of the Company’s continuing focus on research and development and product development which has led on July 21, 2008 to the launch of its first product, ColonSentry™, and the advancement of related products in the Company’s pipeline.

As at June 30, 2008, the Company’s cash and cash equivalents amounted to $6.7 million compared to $11.3 million as at December 31, 2007. The Company believes it has adequate resources to continue through the first quarter of 2009 based on its current cash and cash equivalent position.

As at June 30, 2008 the Company had 55,883,437 common shares and 6,483,738 stock options outstanding.

Management’s Discussion and Analysis of the financial statements for the three-month and six-month periods ended June 30, 2008 is available on SEDAR at www.sedar.com.

Financial statements are available in the attached pdf document.