BG Medicine diagnostic news

BG Medicine reduced headcount by 11 (30%) to 26 as part of its strategy to transition into a commercially focused company to support sales and marketing of its BGM Galectin-3 heart failure risk and CardioSCORE tests. The cuts came from early discovery research. The company expects to save up to $1.2 million in 2013. BG Medicine also said it is building its own sales organization and plans to open the BG Medicine CLIA laboratory next half to support direct sales of its BGM Galectin-3 heart failure risk test to hospitals and other health care providers. Earlier this month, the Centers for Medicare & Medicaid Services (CMS) assigned a payment rate for the test under an analyte-specific current procedural terminology (CPT) code, effective Jan. 1, 2013, but did not award a higher payment rate for the test. At the time, BG Medicine said it would seek an increased Medicare reimbursement rate for 2014. The test is approved in the U.S. as an aid to assess the prognosis of patients diagnosed with chronic heart failure (CHF) (see BioCentury, Nov. 12).

BG Medicine plans to launch its CardioSCORE test initially in Europe, assuming it received CE Mark approval, which the company expects in 1Q13. The company said it is continuing discussions with FDA regarding 510(k) clearance for its CardioSCORE diagnostic. In August, BG Medicine withdrew a 510(k) application for CardioSCORE to identify patients at high risk for near-term major cardiovascular events, including heart attack or stroke. The company did not provide a timeline for a resubmission. The product is an in vitro diagnostic multivariate index (IVDMIA) assay that measures multiple protein biomarkers in blood (see BioCentury, Aug. 13). ...