Publication Reports Clinical Utility of BGM Galectin-3(R) Test for Prediction of Near-Term Rehospitalization in Patients With...
March 25 2014 - 8:30AM
BG Medicine, Inc. (Nasdaq:BGMD) announced today the publication of
results, in the American Heart Journal, of an analysis of
aggregated data from three large, multicenter clinical research
trials in the United States and Europe. The trials included a total
of 902 heart failure patients and demonstrated that elevations of
galectin-3 levels in blood, as measured using the BGM Galectin-3®
Test, were significantly predictive of rehospitalization for heart
failure as early as within the first 30 days following discharge
from an initial hospital stay. [1]
The authors reported that heart failure patients with elevations
in their galectin-3 levels at the time of their hospitalization
were re-admitted within 30 days at nearly three times the rate of
patients without galectin-3 elevation (risk ratio of 2.80 at 30
days, P-value of 0.003). The increased risk conferred by elevations
in galectin-3 was seen to persist at 60, 90 and 120 days in the
study. Galectin-3 testing correctly identified markedly higher risk
among between one-fifth to one-third of all patients who, based on
conventional risk assessment, were placed into a low risk category
at the time of their initial hospital discharge but who,
nonetheless, went on to be rehospitalized or suffer a fatal event
(net reclassification improvement statistic value of +42.6% at 30
days, P-value < 0.001).
In the United States, the annual cost to Medicare of hospital
readmissions within 30 days of discharge has been estimated to
exceed $17 billion. [2] The leading cause of hospital readmissions
among Medicare beneficiaries is heart failure related
complications. [2] The recently enacted Affordable Care Act
required the Centers for Medicare and Medicaid to implement
penalty-based reductions in payments to hospitals with excessive
rates of readmissions within 30 days of hospital discharge. The
Medicare Payment Advisory Commission has concluded that
approximately three-quarters of these hospital readmissions are
potentially preventable. [3]
"We believe that this analysis of data from three significant
clinical research trials further affirms the previously reported
utility of galectin-3 testing as an aid in assessing the prognosis
of patients with heart failure when used in conjunction with
clinical evaluation," said Dr. Paul R. Sohmer, President and CEO of
BG Medicine, Inc. "The identification of heart failure patients who
are at significantly elevated risk for unforeseen events may
facilitate the care of heart failure patients and help control the
cost burden of this disease on healthcare systems worldwide."
The BGM Galectin-3® Test is cleared by the U.S. FDA as an aid in
assessing the prognosis of patients diagnosed with chronic heart
failure when used in conjunction with clinical evaluation.
The BGM Galectin-3® Test is CE Marked and is available in Europe
as an aid in assessing the prognosis of patients diagnosed with
acute and chronic heart failure when used in conjunction with
clinical evaluation. It is also CE Marked for adults as an aid in
assessing the risk of new onset heart failure.
About Galectin-3 and Heart Failure
Galectin-3 is a protein that is involved in fundamental disease
processes including the development of fibrosis in organ tissues,
and cardiac remodeling, which may lead to 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 hospitalization or death. The BGM Galectin-3® Test is to be used
as an aid in assessing the prognosis of patients with chronic heart
failure, in conjunction with clinical evaluation. For more
information please visit www.BG-Medicine.com.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM
Galectin-3® Test, is focused on the development and delivery of
diagnostic solutions to aid in the clinical management of heart
failure and related disorders. For additional information about BG
Medicine, heart failure and galectin-3 testing, please visit
www.BG-Medicine.com.
The BG Medicine Inc. logo is available for download here
Forward Looking Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements regarding: our
belief that this analysis further affirms the previously reported
utility of galectin-3 testing; and our belief that the
identification of heart failure patients who are at significantly
elevated risk for unforeseen events may facilitate the care of
heart failure patients and help control the cost burden on
healthcare systems worldwide. These forward-looking statements are
neither promises nor guarantees of future performance, and are
subject to a variety of risks and uncertainties, many of which are
beyond the Company's control, which could cause actual results to
differ materially from those contemplated in these forward-looking
statements. These risks and uncertainties include, among other
things, the factors discussed under the heading "Risk Factors"
contained in BG Medicine's annual report and quarterly reports
filed with the Securities and Exchange Commission. All information
in this press release is as of the date of the release, and BG
Medicine disclaims any obligation to update the information
contained in this press release as new information becomes
available.
Publication References
1. Meijers WC, Januzzi JL, deFilippi C, et al. Elevated Plasma
Galectin-3 is Associated with Near-Term Rehospitalization in Heart
Failure: A Pooled Analysis of 3 Clinical Trials. American Heart
Journal (2014), doi:10.1016/j.ahj.2014.02.011.
2. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among
patients in the Medicare fee-for-service program. N Engl J Med.
2009 Apr 2;360(14):1418-28. doi:10.1056/NEJMsa0803563.
3. Medicare Payment Advisory Commission. A path to bundled
payment around a rehospitalization. In: Report to the Congress:
reforming the delivery system. Washington, DC:, June
2005:83-103.
CONTACT: Corporate Communications
+1 (781) 890-1199
BG Medicine, Inc.
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