BG Medicine, a developer of cardiovascular diagnostics, has filed 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay.
Designed for use with Abbott’s automated Architect immunochemistry instrument platform, the Architect Galectin-3 assay measures a patient’s Galectin-3 blood protein level, which is implicated in the progression of heart failure.
Eric Bouvier, BG Medicine president and CEO, 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 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.
"We are very pleased with the Abbott collaboration and the development of the Galectin-3 test on the first automated platform."
Currently, BG Medicine is commercialising a manual version of its FDA-cleared BGM test to assess the prognosis of patients diagnosed with chronic heart failure.
In May 2012, BG Medicine filed for an expanded indication of test with the FDA, to identify elevated levels of Galectin-3 in the general adult population associated with an increased risk for new-onset heart failure.
Elevated levels are associated with a more aggressive form of heart failure and 30% or more of mild-to-moderate heart failure patients have elevated levels of Galectin-3, according to the company.
The BGM Galectin-3 test has obtained CE mark approval in the EU for the expanded indication.