ARCHITECT Galectin-3 test regulatory update

BG Medicine disclosed in its 2012 earnings that partner Fujirebio Inc. (Tokyo, Japan) withdrew a 510(k) application for the ARCHITECT Galectin-3 test, an automated version of BG Medicine's BGM Galectin-3 test that is marketed as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (CHF). BG Medicine said Fujirebio received a letter from FDA last July, the same month the application was submitted, requesting additional information on "various matters, including the geographic composition of the patient cohort that provided the blood samples used to support the 510(k)." BG Medicine expects Fujirebio to submit a new 510(k) application next half addressing FDA's questions. BG Medicine said Fujirebio is developing the test for Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) (see BioCentury, July 30, 2012). ...