BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay.
The Architect Galectin-3 assay, which is designed for use with Abbott’s automated Architect immunochemistry instrument platform, measures patient’s blood protein level of galectin-3, which is implicated in the progression of heart failure.
BG Medicine president and CEO Eric Bouvier said the filing of the 510(k) for the Abbott Architect marks an important milestone for the company and further demonstrates its strategy to expand the usage and availability of the galectin-3 test to broader markets.
"Subject to clearance by the FDA, the automated test would enable broader access and more timely information flow to physicians and their patients," Bouvier added.
The company said currently it is marketing a manual version of its FDA-cleared BGM Galectin-3 test to assess the prognosis of patients diagnosed with chronic heart failure.
In May 2012, BG Medicine filed for an expanded indication of BGM Galectin-3 test, with the FDA, to identify elevated levels of galectin-3 in general adult population associated with an increased risk for new-onset heart failure.
The BGM Galectin-3 test has obtained CE mark in the EU for the expanded indication.