BG Medicine and Merck & Co. are joining forces to develop an in vitro diagnostic for lipid disorders. Merck has granted BG Medicine a semi-exclusive license to certain intellectual property and technologies in exchange for testing services, data sharing, and other considerations. BG Medicine is eligible to receive milestone-based payments.
BG Medicine will work to develop an immunoassay and validate its clinical utility as a biomarker. If successful, the company plans to complete these studies and seek regulatory clearance for the test.
“This project holds the potential to improve the management of a common disorder that plays an important role in the risk for heart attack and stroke, two of the most deadly medical conditions of our time,” says Pieter Muntendam, M.D., president and CEO of BG Medicine.
BG Medicine focuses on the discovery, development, and commercialization of molecular diagnostics. It has four cardiovascular-related biomarkers in development as tests for heart failure (HF), HF post myocardial infarction, acute atherothrombosis, and lipid disorders. The HF test, BGM Galectin-3™, is available in for clinical use only in the EU and certain other European countries. The company says that it has submitted a 510(k) application to obtain FDA clearance to sell the test in the U.S.
BGM Galectin-3 measures blood plasma or serum levels of galectin-3, which has been linked to adverse remodeling of the heart. Cardiac remodeling is an important determinant of the clinical outcome of heart failure and is linked to disease progression and poor prognosis.
The company also has discovery-stage programs in multiple sclerosis, autoimmune disorders, and cardio-metabolic diseases. The firm’s strategy is to focus on novel content for existing automated laboratory instruments to facilitate broader and more rapid adoption of its diagnostic tests.