BG Medicine Receives CE Mark for Galectin-3 Test
Published: Apr 10, 2013
The launch of the ARCHITECT Galectin-3 test under CE Mark will further expand the availability of galectin-3 testing in several European countries, pending country registration. BG Medicine is partnering with four diagnostic instrument manufacturers to commercialize automated versions of the BGM Galectin-3 test.
"The launch of the ARCHITECT Galectin-3 test under CE Mark is another important step in our commercial strategy. We are very pleased with the progress made by our partner Abbott, a worldwide leader in in vitro diagnostics, to expand the use of galectin-3 testing in heart failure patients," said Eric Bouvier, President and Chief Executive Officer of BG Medicine. The announcement will strengthen our ability to drive the growth of galectin-3 testing throughout the world."
"Galectin-3 is a powerful indicator of prognosis and risk for readmission in heart failure. Having a rapid turn-around galectin-3 result means heart failure patients at high-risk for such adverse events can be more readily identified," said Stefan Anker MD, PhD and President of the Heart Failure Association of the European Society of Cardiology. "Given the rise in heart failure, it is critical we introduce new tools that aid fast clinical decision making processes and provide options to explore new interventions."
In addition to Abbott, BG Medicine is partnering with Alere Inc., bioMerieux SA, and Siemens Healthcare Diagnostics Inc. to supply automated versions of its galectin-3 test to key segments of the market. Earlier this year, bioMerieux SA launched the test in Europe and in certain other territories that recognize the CE Mark.
About Galectin-3 testing
Galectin-3 has been implicated in a variety of biological processes important in the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of death or hospitalization, including 30-day readmission.
About BG Medicine, Inc.
BG Medicine, Inc. (BGMD) is a diagnostics company focused on the development and commercialization of novel cardiovascular tests to address significant unmet medical needs, improve patient outcomes and reduce healthcare costs. The Company has two products: the BGM Galectin-3(R) test for use in patients with chronic heart failure is available in the United States and Europe; and the CardioSCORE(TM) test for the risk prediction of major cardiovascular events is expected to be launched in Europe in the first half of 2013. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com and www.galectin-3.com.
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Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. Forward-looking statements in this news release address our belief that the launch of the ARCHITECT Galectin-3 test under CE Mark will further expand the availability of galectin-3 testing in several European countries and our belief regarding the importance of the launch in our commercial strategy; our understanding that higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care; and our belief that galectin-3 testing may be useful in helping physicians determine which patients are at high risk of cardiovascular death or hospitalization, including 30-day readmission. Forward-looking statements are based on management's current expectations and involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our recent filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
EVP & Chief Financial Officer