The European Union has granted CE mark approval to BG Medicine’s automated blood test, designed for use in patients with chronic heart failure.
The Galectin-3 test will be made available through bioMerieux‘s VIDAS immunoassay, which consists of about 27,000 installed instruments.
The CE mark is expected to further BG Medicine’s three-pillared business model for rapid commercial adoption of the test through automated partners, specialised labs and the targeting of US hospitals with high readmissions rates.
BG Medicine president and chief executive officer Eric Bouvier said bioMerieux is in a position to drive the adoption of the test in Europe through its broad CE-marked installed base.
"Offering an automated version of the Galectin-3 assay is critical for us to obtain broad-based and rapid global adoption," Bouvier said.
"Partnering with bioMérieux, as well as Abbott, Alere and Siemens provides BG Medicine tremendous international coverage to drive commercial adoption over the next several years.
"2013 is poised to be a year of great progress in our commercial strategy for the manual and automated versions of the BGM Galectin-3 test and we are pleased to begin the year with this important development in the execution of this strategy."
bioMerieux is also preparing a phased launch of the Galectin-3 test in Europe and in certain other territories that recognise the CE mark.