Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay.
Used with Abbott's fully automated ARCHITECT immunochemistry instrument platform, the test measures a patient's blood level of galectin-3, a protein that progresses heart failure.
The new application is expected to be the first measurement of galectin-3 on an automated platform once it receives the FDA approval.
BG Medicine president and CEO Eric Bouvier said the filing of the 510(k) for the Abbott ARCHITECT marks an important milestone for BG Medicine and further demonstrates the company's 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.
