BG Medicine this week announced it is partnering with Siemens Healthcare Diagnostics on the development and commercialization of an automated version of its galectin-3 protein biomarker prognostic for chronic heart failure patients.
The manual version of the test received approval from the US Food and Drug Administration in November, and BGM is currently finalizing commercialization plans with the Laboratory Corporation of America.
In its recently amended preliminary prospectus for its initial public offering, the company said it believes an automated version of the test will be required for it "to achieve broad customer acceptance and clinical adoption." The filing also said BGM hopes to submit a 510(k) pre-market notification to the FDA for an automated test by the fourth quarter of 2011, and to have such a test on the market in the first half of 2012 (PM 12/3/2010).
According to a statement released by BGM this week, under the agreement Siemens will be responsible for "the development of the test in accordance with certain plans and milestones," and both firms "will collaborate in support of development of the test and regulatory filings."
In addition to the Siemens agreement, the company has signed deals with Abbott, Alere, and BioMérieux for the development and commercialization of automated galectin-3 tests.
Also this week, BGM announced the publication of a study in the Annals of Medicine by the Department of Cardiology at the University Medical Centre Groningen in the Netherlands that suggests galectin-3 could be useful as a biomarker for predicting adverse outcomes in heart failure patients with preserved ejection fraction and reduced ejection fraction.
According to the study, this was the first time galectin-3 data had been published on patients with preserved ejection fraction, which make up roughly half of all heart failure patients.