Biotechnology Focus

Biotechnology Focus February 2013

Biotechnology Focus is Canada's leading authority on Canada's life science news. From biopharma and healthcare to ag-bio and clean tech, our readership includes life science professionals, C-level executives and researchers.

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Chronic Diseases The goal of the program includes providing proper self-management education to these at-risk patients and to establish follow-up care procedures either with their family physician or the COPD clinic. — Bruce McManus PROOF Centre clinical coordinators consent a subject in one of our heart failure studies in the Heart Function Clinic at St. Paul's Hospital. Credit: Aaron Aubrey Photography for all aspects of data handling and storage. This quality-driven approach ensures that the vast amounts of data remain valuable assets. To this end, the PROOF Centre was awarded the 2010 Bio-IT World Best Practices Award for Personalized & Translational Medicine. The PROOF Centre's lead programs in chronic obstructive pulmonary disease (COPD), heart failure, and transplantation are projected to result in the commercialization of five biomarker blood tests by 2018. One of our tests that will improve care for COPD is discussed in more detail below. Chronic Obstructive Pulmonary Disease (COPD) Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and is expected to be the third leading cause of death worldwide by the year 2020, with much of this increase resulting from an exponential rise in COPD mortality among women. Lung exacerbations, or 'lung attacks' are experienced by about a third of those who suffer from COPD – a progressive disease that causes reduced lung function in the form of shortness of breath and coughing. When a lung attack takes place, the symptoms of COPD worsen resulting in increased breathlessness, coughing, and wheezing. Lung exacerbations not only take a physical and emotional toll on those with COPD, but are also an enormous burden to the healthcare system. Such exacerbations are the leading cause of emergency room visits and hospitalizations among chronic disease sufferers in British Columbia (BC), and across the country. Consequently, lung attacks can incur over $5.7 billion in direct and $6.7 billion in indirect healthcare costs every year in Canada. There is a large and compelling unmet medical need and a socioeconomic imperative for identifying markers of COPD exacerbation. Physicians lack objective measurements to accurately risk-stratify patients and monitor the effectiveness of interventions provided for their patients. Currently, the only test in clinical use is lung function measured by forced expiratory volume in one second (FEV1). However, FEV1 has limited utility because it cannot separate the different phenotypes nor reliably predict those who will exacerbate from those who will not. To address the devastating and costly impacts of COPD exacerbations, the PROOF Centre, Genome BC, Siemens Healthcare Diagnostics, Providence Health Care, and HTG Molecular Diagnostics are providing much needed funding to develop a simple blood test that can determine if a person is at risk for a lung attack. The PROOF Centre team, working with Dr. Don Sin, project leader and head of Respiratory Medicine at St. Paul's Hospital, and investigators from GlaxoSmithKline have identified unique gene and protein biomarkers that have the ability to predict which patients will likely have frequent lung attacks. Our blood tests outperformed the currently used test, FEV1. The goal is to put this test in the clinical laboratory and be available to any physician in BC. This would be a huge step forward from the current diagnosis method: a breathing test that is available only in certain centres in the province and which must be performed by specially trained staff. This predictive test will also provide a more accurate picture of a patient's condition, and will allow physicians to better treat and manage COPD. The development of a predictive test for COPD lung attacks highly complements the initiatives undertaken by the BC Ministry of Health to overcome COPD. Already, a plan is in place to mobilize COPD experts at three Lower Mainland hospitals who will identify lung attack patients seen at each site. The goal of the program includes providing proper self-management education to these at-risk patients and to establish follow-up care procedures either with their family physician or the COPD clinic. Such a program opens the door for a seamless transition from laboratory-based discovery to effective patient management targeting the prevention of fatal lung attacks. Prospect Thus, the PROOF Centre blood tests will save lives, improve quality of life, and save precious healthcare dollars with increasing rate of return. Our transplant, COPD, and heart failure tests combined are projected to save more than $3B in Canada and increase patient quality of life (QALY) five years after test implementation. Our blood tests will also be used by family practice physicians with practice guidelines integrated into the clinical reporting system for improved decision making. To see this story online visit http://biotechnologyfocus. ca/biomarker-signatures-andhealthcare-solutions/ February 2013 BIOTECHNOLOGY FOCUS 17

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