GeneNews - Press Release feed

New Study Demonstrates Value of ColonSentry™ as Pre-screening Alert to Enhance Effectiveness of Colorectal Cancer Screening

jying — Tue, 24 Aug 2010 11:18:28 -0500

Date: Tue, 2010-08-24 16:00

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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, announced that a poster describing a 786-cohort study entitled "Blood RNA Biomarker Detects Both Left- and Right-sided Colorectal Neoplasms" has been accepted for presentation at the Next Generation Dx Summit, held at the Ritz-Carlton in Washington, DC from August 24-26.

The poster reports on the application of a seven gene biomarker panel to 377 colorectal cancer ("CRC") patients and 409 controls. This seven gene biomarker panel forms the basis of the company's lead product, ColonSentry™, the world's first blood test to assess an individual's current risk for colorectal cancer. The poster concludes that the biomarker panel was able to detect right-sided CRC lesions across all stages with a sensitivity that is at least equal to the detection observed for left-sided lesions.

"Colonoscopy is widely regarded as the gold standard for colorectal cancer detection. Recent studies, however, suggest that its effectiveness is mostly confined to detection of tumors on the left side of the colon, with poor detection of right-sided lesions. Routine use of a blood test that can detect both left-sided and right-sided lesions could increase the effectiveness of colorectal cancer screening by revealing the potential presence of neoplasms in advance of colonoscopy," said Dr. Robert Burakoff, one of the investigators for the reported study, Clinical Chief of Gastroenterology and Director of the Center for Digestive Diseases and of the Crohn's and Colitis Center at Brigham and Women's Hospital, Harvard Medical School.

"We have long believed that widespread adoption ColonSentry™ would encourage more patients to engage in colorectal cancer screening, leading to earlier detection, improved patient outcomes and reduced healthcare costs. The results from this study further demonstrate the value of using ColonSentry™ as a routine test in advance of colonoscopy to provide a pre-screening alert, ultimately leading to enhanced colorectal cancer screening effectiveness," said Gailina J. Liew, President & Chief Operating Officer of GeneNews.

GeneNews Reports Second Quarter 2010 Financial Results

jying — Wed, 11 Aug 2010 08:52:40 -0500

Date: Wed, 2010-08-11 01:00

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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 three- and six- months ended June 30, 2010.

Recent highlights:

Executed a formal marketing partnership agreement with GeneDiagnostics Inc. to market and sell ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer, in China.
Presentation of positive ColonSentry™ validation data from a 210-patient Malaysian study entitled "Blood-based Seven-gene Biomarker Panel for Colorectal Cancer: Validation in Malaysia" at the 2010 National Committee for Clinical Research conference, Kuala Lumpur, Malaysia June 2 to 4.
Granted two new U.S. patents for Schizophrenia and Osteoarthritis, representing specific practical applications of the Company's core platform technology, the Sentinel Principle®.
Management and Board changes including the appointment of Ms. Leslie Auld as Chief Financial Officer, the election of Ms. Gailina J. Liew, GeneNews' President and Chief Operating Officer, to the Company's Board of Directors and the re-election of six incumbent directors at the Company's annual shareholder meeting.

"Throughout the second quarter, we continued to focus on the commercialization of our lead product, ColonSentry™. Now, as we move into the second half of the year, we will continue to work with our U.S. marketing partner, Enzo Clinical Labs, and our Chinese marketing partner, GeneDiagnostics, as they prepare to launch ColonSentry in their respective territories," said Ms. Liew. "At the same time, we will continue to pursue financing activities and discussions with additional potential ColonSentry™ marketing and strategic partners for other regions of the United States, Europe and Asia."

Financial results:

For the three months ended June 30, 2010, the Company reported a consolidated net loss of $1,291,648, or $0.02 loss per common share, as compared to a consolidated net loss of $1,755,474, or $0.03 loss per common share for the three months ended June 30, 2009. For the six months ended June 30, 2010, the Company reported a consolidated net loss of $2,729,136, or $0.04 loss per common share, as compared to a consolidated net loss of $3,724,755, or $0.07 loss per common share, for the six months ended June 30, 2009. This year-to-date improved financial performance is primarily due to a 38% reduction in research and development costs that resulted from reductions in the number of scientific and technical staff needed to support the Company's ColonSentry™ test service through its Canadian operations.

As at June 30, 2010, the Company's unrestricted cash and cash equivalents, cash held in trust and short-term investments amounted to $1,090,144. Subsequent to quarter-end, the Company received over $800,000 in non-dilutive cash, primarily into the Company's Malaysian subsidiary for the development of liver cancer and hepatitis biomarkers.

As previously disclosed, the Company has 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, to assist in expanding the Company's shareholder base and accessing additional working capital to support the pursuit of its milestones in 2010.

The Company's financial statements and management's discussion and analysis are available on www.sedar.com.

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

Attached file: GeneNews_2010Q2_Statement.pdf (8.88 KB)

GeneNews Executes Marketing Partnership Agreement with GeneDiagnostics

jying — Wed, 30 Jun 2010 08:14:35 -0500

Secondary Title: - Target Q4 2010 ColonSentry™ Launch in China -

Date: Wed, 2010-06-30 01:00

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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 executed a formal marketing partnership agreement with GeneDiagnostics Inc. (“GD”) to market ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer, in China.

As noted in a previous press release dated May 19, 2010, the agreement provides GD with non-exclusive rights to market and sell the ColonSentry™ test in Shanghai and the provinces of Zhejiang and Jiangsu. GD is targeting the fourth quarter of 2010 for the commercial launch of ColonSentry™. Financial terms were not disclosed.

According to the Chinese Anti-Cancer Association, the annual growth rate for colorectal cancer in China is 4.2%, more than double the global average of 2%, resulting in roughly 400,000 new cases of colorectal cancer in China each year. The total number of colorectal cancer patients in China has exceeded the total in the United States and onset of the disease in Chinese patients is about 10 years earlier than observed in North America and Europe. The highest incidence areas in China for colorectal cancer are the Yangtze River Delta (Shanghai and provinces of Zhejiang, Jiangsu) and the Zhujiang River Delta (Hong Kong, Macau and the province of Guangdong).

“The incidence of colorectal cancer in China has risen dramatically in recent years and will likely continue to rise over the next two decades as the Chinese increasingly adopt Western lifestyles and diets”, said Mark Han MD PhD, President of GeneDiagnostics. “We are delighted to be working with GeneNews to bring the benefit of this groundbreaking test to people in China which can lead to earlier detection of colorectal cancer.”

"ColonSentry™ is a patient-friendly blood test that can be easily incorporated into a routine physical examination to alert doctors and patients to move forward to colonoscopy,” said Gailina J. Liew, President & Chief Operating Officer of GeneNews. “We are very pleased to be working with Dr. Han and look forward to building a strong and mutually beneficial partnership with him and GeneDiagnostics.”

Malaysian Study Further Validates GeneNews' ColonSentry™ Test

jying — Thu, 03 Jun 2010 12:03:27 -0500

Date: Thu, 2010-06-03 05:00

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GeneNews Limited (GEN), a company focused on developing blood-based biomarker tests for the early detection of diseases and personalized health management, announced that an abstract describing a 210-patient Malaysian study entitled "Blood-based Seven-gene Biomarker Panel for Colorectal Cancer: Validation in Malaysia" was presented yesterday at the 2010 National Committee for Clinical Research conference, Kuala Lumpur, Malaysia, June 2 to 4.

The abstract reported on the application of the seven gene biomarker panel to 99 colorectal cancer patients and 111 controls. The seven gene biomarker panel forms the basis of the company's lead product, ColonSentry™, the world's first blood test for colorectal cancer.

Quoting directly from the abstract, "Screening is key to colorectal cancer prevention and mortality reduction, but patient compliance with faecal testing and endoscopy is low. We have previously reported our patient-friendly blood-based test for colorectal cancer current risk stratification (Marshall KW, Mohr S, El Khettabi F, Nossova N, Chao S, Bao W, et al. Blood-based biomarker panel for stratifying current risk for colorectal cancer. Internat J Cancer 2010;126:1177-86). The test utilizes a seven-gene panel of biomarkers, which was validated using blood samples collected from North American patients at average risk for colorectal cancer. In this study, we evaluate this seven-gene biomarker panel in blood samples collected from patients in Malaysia."

The abstract concluded, "Our results independently confirmed and validated the study previously conducted in North America and demonstrate the performance of the seven-gene biomarker panel to discriminate between colorectal cancer and control blood samples in Malaysia."

"It is well established that the greatest barrier to reducing mortality arising from colorectal cancer is patient compliance with screening. ColonSentry&trades; provides a blood-based testing option that can be easily incorporated into a routine physical examination. We believe that widespread adoption of this practice would encourage more patients to be tested and enhance the effectiveness of colonoscopy, leading to earlier detection, improved patient outcomes and reduced healthcare costs," said Gailina J. Liew, President & Chief Operating Officer of GeneNews.

GeneNews Partners with GeneDiagnostics Inc. to Market ColonSentry™ in China

jying — Wed, 19 May 2010 08:03:50 -0500

Date: Wed, 2010-05-19 01:00

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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 executed a binding term sheet with GeneDiagnostics Inc. ("GD"), a private clinical research and services company in China, for the non-exclusive rights to market ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer.

The term sheet sets forth the main criteria to be incorporated into a definitive marketing partnership agreement under which GD would obtain non-exclusive rights to market and sell the ColonSentry™ test in Shanghai and the provinces of Zhejiang and Jiangsu where a combined population of more than 38 million men and women aged 50 or older reside. GeneNews expects that the negotiation and execution of a formal marketing partnership agreement will be completed before the end of the Company's current fiscal quarter.

"We are delighted to be working with GeneDiagnostics, our first ColonSentry™ marketing partner in China. The engagement of additional partners to establish a global ColonSentry™ marketing and distribution network is a key objective for GeneNews in 2010 and the signing of this binding term sheet with GeneDiagnostics is an important step towards achieving that goal," said Gailina J. Liew, President & Chief Operating Officer of GeneNews.

GeneNews Issued U.S. Patents for Schizophrenia and Osteoarthritis Based on Core Sentinel Principle® Platform

jying — Tue, 11 May 2010 08:22:51 -0500

Date: Tue, 2010-05-11 05:00

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The first, U.S. Patent No. 7,713,702 entitled "Biomarkers for Diagnosing Schizophrenia," covers any analysis of a blood sample in which the expression pattern of a 9-gene panel is assessed in a diagnosis of schizophrenia. The second, U.S. Patent No. 7,713,695 entitled "Mild Osteoarthritis Biomarkers and Uses Thereof," protects any analysis of a blood sample in which a characteristic expression of a specific marker gene is determined in a diagnosis of mild osteoarthritis. Both patents represent specific practical applications of GeneNews' proprietary Sentinel Principle®, which is based on the concept that all states of health and disease are associated with characteristic gene expression signatures.

"We continue to actively pursue additional patent issuances with the goal of expanding the scope of protection for the Company's Sentinel Principle® 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," said Dr. Heiner Dreismann, Lead Director and Interim CEO of GeneNews.

"Both schizophrenia and mild osteoarthritis are difficult to diagnose due to the lack of objective, convenient and, in the case of mild osteoarthritis, non-invasive, measures for assessing the likelihood that a patient has the condition," said Gailina Liew, President & Chief Operating Officer of GeneNews. "These two patents protect unique clinically actionable biomarkers that can be used to develop simple blood-based tests to facilitate early diagnosis of these diseases. We are interested in engaging with partners that can work with us to co-develop these products."

The Sentinel Principle®, a platform technology discovered and developed by GeneNews, is based on the concept that all clinical conditions and body states, including those resulting from disease or in response to treatment, generate characteristic gene expression signatures in the blood as a result of the constant and dynamic physiological interaction of blood with the cells, tissues and organs of the human body. This technology is the basis of GeneNews' initial product, ColonSentry™, the world's first blood test for colorectal cancer. ColonSentry™ was launched in Canada in 2008 and is poised to enter the New York and New Jersey markets in the second half of 2010 through GeneNews' exclusive partnership for these U.S. states with Enzo Clinical Labs. GeneNews' broad patent portfolio includes pending patents related to these foundational patents in diverse disease areas such as cancer, cardiovascular, neurological and inflammatory conditions.

GeneNews to Feature ColonSentry™ at the 8th Annual Primary Care Today Conference

jying — Wed, 05 May 2010 11:36:06 -0500

Date: Wed, 2010-05-05 20:00

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GeneNews Limited (GEN), an emerging molecular diagnostics company focused on the application of functional genomics to enable early diagnosis and personalized health management, today announced that it will be exhibiting at the Primary Care Today educational conference and medical exposition being held at the International Center, May 6-8, 2010 in Toronto. GeneNews' exhibit, at booth No. 1108, will feature the Company's lead product, ColonSentry™, the world's first blood-based test to determine a person's current risk for colorectal cancer.

"Primary Care Today is produced in partnership with Canada's largest medical school, the University of Toronto's Department of Family & Community Medicine, and is expected to attract more than 2,000 family physicians, general practitioners and healthcare professionals," said Gailina J. Liew, President and Chief Operating Officer of GeneNews. "We believe that increasing doctor awareness and acceptance of ColonSentry™ through our participation in events like this will go a long way towards achieving our goal of expanded adoption and use of the test in Canada."