NEW YORK (GenomeWeb) – BG Medicine's stock was down as much as 43 percent in morning trading on the OTC market following the company's announcement today that it has withdrawn its 510(k) premarket notification with the US Food and Drug Administration for an expanded indication of its BGM Galectin-3 test.
BG had hoped to obtain 510(k) clearance for use of the test in assessing the near-term risk of fatal cardiovascular events in older adults with no prior history of cardiovascular disease, cerebrovascular disease, or vascular disease.
The company filed the premarket notification in March 2015 and in August 2015 received a request from FDA for additional information. Following additional discussions with FDA, BG determined that providing this additional information, and information on clinical utility, specifically, would require a new 510(k) submission. The company has chosen instead to withdraw the notification.
BG said that it now plans to "evaluate what additional data, studies, and analyses would be required to support a new submission and a broader indication for use."
"We believe that the decision to withdraw this submission and to evaluate the possibility of pursuing the assessment of near-term risk for both fatal and non-fatal cardiovascular events among older adults, a more clinically useful indication for use, provides the best opportunity to create value from the work that we have completed to date," BG President and CEO Paul Sohmer said in a statement.