DGAP-News: BG Medicine Obtains CE Mark for CardioSCORE(TM) Test in Europe
(firmenpresse) - BG Medicine Inc.
11.12.2012 14:30
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Innovative Blood Test for the Prediction of Major Cardiovascular Events
Expected to Launch in the First Half of 2013
WALTHAM, Mass., 2012-12-11 14:30 CET (GLOBE NEWSWIRE) --
BG Medicine, Inc. (Nasdaq:BGMD), a diagnostics company focused on the
development and commercialization of novel cardiovascular tests, today
announced that it has obtained a CE Mark enabling the commercial sale of the
CardioSCORE(tm) test in the EU and other countries that recognize the CE Mark. The
CardioSCORE test is the company's patented diagnostic blood test designed to
dramatically improve risk prediction of major cardiovascular events beyond
traditional risk factor assessments, such as the Framingham Risk Score and
European SCORE.
The CardioSCORE test is performed on a standard blood sample and utilizes
algorithmic analysis to combine the results of seven reimbursed protein assays.
The test involves an independent scoring system that yields a quantitative
result ranging from 0.0 to 10.0, with higher values indicating elevated risk
for a major cardiovascular event in the subsequent 3 years and with each 1.0
point increment representing a 30% increase in relative risk. In the 6,600
patient BioImage Study cohort, the primary clinical validation study for the
CardioSCORE test, among those who experienced a near-term major cardiovascular
event during follow-up, only 26% were identified as being at high risk at
baseline by traditional risk factors, whereas 54% percent were identified as
being at high risk upon addition of their CardioSCORE result (p<0.0001).
'We are thrilled to bring the benefits of the CardioSCORE test to patients and
physicians in Europe. We believe this test will be a pivotal and disruptive
game-changer in the primary prevention of major cardiovascular events and
treatment of disease, representing a major advancement over the diagnostic
tools clinicians have used for the past 15 years,' said Eric Bouvier, President
and Chief Executive Officer of BG Medicine. 'The majority of cardiovascular
events occur among patients who are asymptomatic, and current risk factor
assessment methods simply miss too many patients with hidden subclinical risk,
delaying appropriate therapy and effective monitoring of response to such
therapy. The CardioSCORE test will identify individuals at elevated risk for
heart attack and stroke, enabling preventive intervention. We are working
aggressively to launch the test in the first half of 2013 in Europe in
collaboration with specialty laboratory partners.'
'The CardioSCORE test may have the potential to help improve the care of many
people by providing a simple, accurate and clinically meaningful score to
assess an individual's risk for near-term major cardiovascular events,' said
Valentin Fuster, MD, PhD, Professor of Cardiology and Director of Mount Sinai
Heart.
Last month, investigators at the American Heart Association (AHA) Scientific
Sessions 2012 presented the results of several analyses of the CardioSCORE test
performance in the BioImage Study. The presentations by investigators from the
Mt. Sinai School of Medicine and the Baptist Hospital of Miami highlighted the
predictive value of the test in assessing risk for near-term major
cardiovascular events across a broad and diverse community-dwelling population.
A summary of these findings is available here:
http://investor.bg-medicine.com/releases.cfm.
'Obtaining the CE Mark for the CardioSCORE test is not only a significant
milestone in the prevention and treatment of cardiovascular disease but also a
critical advancement in our company's continued transformation into a
full-scale commercial organization,' continued Mr. Bouvier. 'BG Medicine now
has two products covering the continuum of heart disease diagnostics,
positioning us strongly to drive the clinical usage of our important diagnostic
tests for millions of patients who will benefit from them throughout the
world.'
The CardioSCORE test is not yet available commercially in the United States. BG
Medicine is continuing its active discussions with the US Food and Drug
Administration regarding 510(k) clearance for the test in the United States.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq: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 will 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.
The BG Medicine Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10352
Special Note Regarding Forward-looking Statements
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 in the significant potential of the CardioSCORE test to provide valuable
information about an individual's risk of experiencing near-term major
cardiovascular events; our belief in the importance of receiving CE Mark in the
EU in order to foster widespread adoption of the CardioSCORE test and as a
means of broadening our commercialization efforts for our diagnostics tests
generally; our belief that there is a critical need for a simple and
easy-to-use blood test to more accurately determine patients' risks for
near-term major cardiovascular events. 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.
CONTACT: Chuck Abdalian
EVP&Chief Financial Officer
(781) 434-0210
News Source: NASDAQ OMX
11.12.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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