ARCHITECT Galectin-3 test regulatory update

BG Medicine said partner Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) received CE Mark approval 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). The test measures a patient's blood level of galectin-3 (LGALS3), a soluble beta-galactoside-binding lectin associated with the formation of cardiac fibrosis, in human plasma or serum, and runs on Abbott's Architect automated immunochemistry instrument. In November 2009, BG Medicine partnered with Abbott to develop and commercialize LGALS3 diagnostics to run on Abbott's Architect platform and other diagnostic instruments (see BioCentury, March 15, 2010).

BG Medicine partner Fujirebio Inc. (Tokyo, Japan) withdrew a 510(k) application for the ARCHITECT Galectin-3 test after FDA requested additional clinical data information last July. BG Medicine expects Fujirebio, which is developing the test for Abbott, to submit a new 510(k) application next half (see BioCentury, April 1). ...