New CE Mark Brings BG Medicine Closer to Commercial Launch of Cardio Assay

BG Medicine Inc. has received a CE mark for the first automated version of its BGM Galectin-3 blood test, marking a key step toward commercializing the cardiovascular diagnostic. BG Medicine will distribute the test through bioMérieux's VIDAS immunoassay platform, which is installed in more than 27,000 instruments around the world, according to the Waltham, MA–based manufacturer. The French-based IVD firm is one of four partners BG has signed up to bring the automated version of the Galectin-3 to market. A phased launch is set for Europe and other countries that recognize the CE mark, BG says. The other partners are Abbott Laboratories, Alere, and Siemens.
The test could play a large role in mitigating the rate of heart failure, says Eric Bouvier, president and CEO of BG Medicine. The company points to statistics showing that heart-failure patients with elevated levels of the galectin-3 protein are up to three times more likely to be readmitted to the hospital within 30 days of discharge than other heart-failure patients. New CMS guidelines have increased financial penalties for hospital readmissions, BG notes.
Receiving the CE mark is one part of a three-pronged business model for launching the test, BG says. The model comprises increasing hospital sales of the galectin-3 test, converting U.S. field operations from an educational to a sales footing, and opening a CLIA laboratory in the first half of 2013.
---John Conroy