"The automated versions of the galectin-3 test are under development by our commercialization partners, Abbott Laboratories, Alere, Siemens, and bioMerieux," continued Dr. Muntendam. "We expect that our partners will begin FDA clearance submissions for their automated versions of the test starting in the fourth quarter of 2011.
"AMIPredict is in development by the Company as a test to identify people at risk for near-term heart attack. Identifying patients before their first heart attack is a significant unmet medical need, and we believe that AMIPredict could be an improved diagnostic test compared to conventional risk factor-based approaches for heart attack and stroke risk. Furthermore, we believe that identification of those at risk could enable targeted primary prevention, such as anti-platelet and anti-thrombotic therapies. We expect to complete the remaining development of AMIPredict in the second or third quarter of 2011, and, if successful, we expect to file a 510(k) application with the FDA shortly thereafter," said Dr. Muntendam.
"Approximately five years ago, we set out to create a new type of diagnostic company - a company that focuses on the discovery and development of novel, high value assays and that we make available through partnerships with leading diagnostic companies. Last year, we turned that concept into reality by announcing multiple new partnerships and obtaining FDA clearance for our first partnered product. This year, we will focus on raising awareness of our products with clinicians in preparation for the expected launch of the automated versions of our galectin-3 test commencing in 2012," said Dr. Muntendam.
"In February of this year, we completed our initial public offering, raising net proceeds to the Company of approximately $35.1 million. We believe that the net proceeds of the offering will provide us with the capital to invest in the launch of the galectin-3 test in 2011 and 2012, as well as to continue the development of our pipeline products," said Michael Rogers, Executive Vice President and Chief Financial Officer of BG Medicine.