(BGMD) Automated VIDAS(R) Galectin-3 Assay Validated in Published Clinical Research Study
WALTHAM, Mass., Jan. 28, 2014 — BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, welcomed today the publication of results of a clinical research study that demonstrate and validate the analytical and clinical performance of the automated VIDAS® Galectin-3 assay that was developed by bioMérieux SA, a world leader in the field of in vitro diagnostics and one of BG Medicine’s automation partners.
In this clinical research study, published online ahead of print in the journal Clinica Chimica Acta, elevated galectin-3 levels in previously collected blood samples, measured using the VIDAS® Galectin-3 assay, were reported to be significantly predictive of fatal cardiovascular events and severity of heart failure among the 137 patients diagnosed with chronic heart failure who were tested.[1] The prognostic information provided by the VIDAS® Galectin-3 assay in this published clinical research study was found to be complementary and additive to that obtained by measurement of three different types of natriuretic peptides, including BNP, NT-proBNP and proBNP. The significant predictive value of galectin-3 levels was further demonstrated to be independent of other key clinical parameters, such as impaired kidney function, reduced cardiac left ventricular pumping capacity, and age. When evaluated for analytical performance, measurement values obtained with the VIDAS® Galectin-3 assay were found to be in excellent agreement with those obtained with the BGM Galectin-3® Test.
“We are very pleased with the results obtained with the automated VIDAS® Galectin-3 assay in this clinical research study,” said Dr. Paul R. Sohmer, President and CEO of BG Medicine, Inc. “These results support commercialization of the VIDAS® Galectin-3 assay in Europe and substantiate our efforts to assist bioMérieux with its pursuit of 510(k) clearance of the assay in the U.S.”
The VIDAS® Galectin-3 assay was developed by bioMérieux for the quantitative measurement of galectin-3 levels in blood using the bioMérieux VIDAS automated and multiparametric immunoassay testing system. The VIDAS® Galectin-3 assay requires 200 microliters of blood plasma or serum and is designed to return test results within 20 minutes. [2] This automated and quantitative assay for galectin-3 in blood is CE Marked and currently available in Europe as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.
[1] Gruson D, Mancini M, Ahn SA, Rousseau MF. Galectin-3 testing: Validity of a novel automated assay in heart failure patients with reduced ejection fraction, Clin Chim Acta (2013), http://dx.doi.org/10.1016/j.cca.2013.12.017.
[2] bioMérieux SA. (2014). VIDAS® Galectin-3. Retrieved from http://www.biomerieux-diagnostics.com/servlet/srt/bio/clinical-diagnostics/dynPage?open=CNL_CLN_PRD&doc=CNL_CLN_PRD_G_PRD_CLN_99&pubparams.sform=0&lang=en.
About Galectin-3 and Heart Failure
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 hospital readmission.
The BGM Galectin-3® Test quantitatively measures galectin-3 protein concentrations in blood serum and plasma. It 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 also CE Marked and 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, and as an aid in assessing the risk of new onset heart failure in adults.
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 the results of the published clinical research study discussed herein support the commercialization of the bioMérieux VIDAS® Galectin-3 assay. 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.
CONTACT: Corporate Communications +1 (781) 890-1199 BG Medicine, Inc.
TraderPower Featured Companies
- Astrotech Corp. (NASDAQ: ASTC)
- Cepton Inc. (NASDAQ: CPTN)
- Clene Inc. (NASDAQ: CLNN)
- CNS Pharmaceuticals Inc. (NASDAQ: CNSP)
- Eloro Resources Ltd. (TSX.V: ELO) (OTCQX: ELRRF)
- Freight Technologies Inc. (NASDAQ: FRGT)
- InMed Pharmaceuticals Inc. (NASDAQ: INM)
- Lexaria Bioscience Corp. (NASDAQ: LEXX)
- Mullen Automotive Inc. (NASDAQ: MULN)
- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)
Top Small Cap Market News
- $NTRB InvestorNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Closes $8.4M Private Placement
- $MULN Europe Now Has Two Countries Fully Dependent on Green Energy
- $TTSRF Tartisan Nickel Corp. (CSE: TN) (OTCQB: TTSRF) (FSE: 8TA) Retains Northwest Solutions Inc. to Complete Kenbridge Nickel Project All-Season Access Road
- $TMET InvestorNewsBreaks – Torr Metals Inc. (TSX.V: TMET) Announces Promising Preliminary Results at Kolos
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp.’s (SFWJ) Eko2o S.A.S. Marks Significant Step in Strategy to Increase Global Footprint
- $DLMI InvestorNewsBreaks – Diamond Lake Minerals Inc. (DLMI) Partners with BOXABL to Expand Opportunities for Modular Housing Villages
- $ZDPY Zoned Properties Inc. (ZDPY) Advancing Initiatives Through the Cannabis Sector
- $ASTC Advancements in Medical AI Are Improving Timely Esophageal Cancer Detection
- $PXMD InvestorNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Completes Key Step in Preparation of PAX-101 for NDA Submission to FDA
- $PXMD “Urgent Action: PaxMedica Inc. (NASDAQ: PXMD) Addresses Medical Crisis in Malawi”
- $BBUZ Bebuzee Inc. (BBUZ) Unveils America’s First Superapp, Pioneering a New Era of Social Connectivity
- $ATBHF InvestorNewsBreaks – Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Announces Strategic Agreement and Advisory Board Appointment
Recent Posts
- $ATBHF InvestorNewsBreaks – Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Announces Strategic Agreement and Advisory Board Appointment
- $BBUZ Bebuzee Inc. (BBUZ) Unveils America’s First Superapp, Pioneering a New Era of Social Connectivity
- $PXMD “Urgent Action: PaxMedica Inc. (NASDAQ: PXMD) Addresses Medical Crisis in Malawi”
- $PXMD InvestorNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Completes Key Step in Preparation of PAX-101 for NDA Submission to FDA
- $ASTC Advancements in Medical AI Are Improving Timely Esophageal Cancer Detection
- $ZDPY Zoned Properties Inc. (ZDPY) Advancing Initiatives Through the Cannabis Sector
- $DLMI InvestorNewsBreaks – Diamond Lake Minerals Inc. (DLMI) Partners with BOXABL to Expand Opportunities for Modular Housing Villages
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp.’s (SFWJ) Eko2o S.A.S. Marks Significant Step in Strategy to Increase Global Footprint
Recent Comments
Archives
- April 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009