CardioSCORE regulatory update

BG Medicine withdrew a 510(k) application to FDA for its CardioSCORE diagnostic to identify patients at high risk for near-term major cardiovascular events, including heart attack or stroke. BG Medicine made the decision after determining that it would not be able to submit additional information that FDA had asked for by Aug. 15. According to the company, FDA asked the company to conduct an adjudication process to confirm data from the pivotal BioImage validation study. Data from the study showed that testing with CardioSCORE at baseline significantly improved the identification of subjects at high risk for near-term major cardiovascular events over conventional risk scoring throughout a median follow-up of 2.5 years. ...