WALTHAM, Mass., July 27, 2015 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD) announced today that, in conjunction with the U.S. market introduction of automated testing for galectin-3, clinical and analytical performance data for galectin-3 testing using an Abbott ARCHITECT® automated immunoassay analyzer will be presented at the 2015 American Association for Clinical Chemistry (AACC) Annual Meeting to be held in Atlanta, GA from July 26 to July 30, 2015.
The AACC is a leading scientific and medical professional organization dedicated to clinical laboratory science and its application to healthcare. The AACC Annual Meeting is the largest global laboratory medicine meeting and exposition, with over 17,000 laboratory medicine and healthcare professionals in attendance.
"The AACC Annual Meeting is an ideal venue for introducing automated testing for galectin-3," said Paul R. Sohmer, M.D, President and CEO of BG Medicine. "The meeting provides a unique opportunity to communicate the value of automated galectin-3 testing to laboratory professionals through both formal presentation and informal discussion."
The meeting's scientific program includes a presentation entitled "An ARCHITECT Assay for Quantitation of Galectin-3 in Human Serum and Plasma," that was authored by scientists from Fujirebio Diagnostics Inc. and BG Medicine Inc., and clinicians from the University of Pennsylvania.[1] These investigators will present analytical precision, accuracy, and sensitivity data for the automated ARCHITECT Galectin-3 assay, and report a suitable measurement range spanning clinically relevant values, with equal to or less than 0.3% cross-reactivity by potential cross-reactants. Additionally, the authors will present results of a clinical study of 405 chronic heart failure patients whose blood was analyzed with the automated ARCHITECT Galectin-3 assay, and report that high levels of galectin-3 are significantly and independently associated with elevated risk of hospitalization due to worsening heart failure, ventricular assist device placement, cardiac transplantation or all-cause mortality in heart failure.
"We believe that the clinical and analytical performance characteristics of the ARCHITECT Galectin-3 test that are being presented at this meeting are compelling and will serve to highlight the utility of this automated assay," concluded Dr. Sohmer.
The ARCHITECT Galectin-3 automated blood test was recently cleared by the United States Food and Drug Administration (FDA) for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The ARCHITECT Galectin-3 assay is available on Abbott's ARCHITECT automated immunoassay analyzer, and is being commercialized through an agreement between BG Medicine and Abbott.
ARCHITECT® Galectin-3 Assay Intended Use and Important Safety Information
For In Vitro Diagnostic Use
Intended Use: The ARCHITECT Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and EDTA plasma. The ARCHITECT Galectin-3 assay may be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF). The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.
Important Safety Information: Results should be interpreted along with clinical findings and other laboratory test results. Levels of galectin-3 in blood may be increased in patients with certain cancers and conditions associated with organ fibrosis. The ARCHITECT Galectin-3 assay is not indicated for detection, diagnosis, prognosis, or any uses associated with any type of cancer, conditions associated with organ fibrosis, or any other condition not noted under the INTENDED USE section.
CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.
For complete information, see the assay specific package insert on www.abbottdiagnostics.com.
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.[2] Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of hospitalization or death. Galectin-3 testing 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 the opportunity afforded by introducing the first automated galectin-3 test at AACC and the compelling nature of the data being presented in support of the utility of the automated test. 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.
References:
[1] 2015 American Association for Clinical Chemistry Annual Meeting Abstracts. Abstract B-008, p. S-138. Available at: https://www.aacc.org/science-and-research/annual-meeting-abstracts.
[2] de Boer R, Lok D, Jaarsma T, et al. Predictive value of plasma galectin-3 levels in heart failure with reduced and preserve ejection fraction. Annals of Medicine. 2011; 43: 60-68.