BG Medicine ($BGMD) may have paused U.S. regulatory plans for its CardioScore blood test to identify cardiovascular disease. But the company is ready to hit the ground running overseas, now that a CE mark approves its diagnostic to screen patients who have an elevated risk for heart attack and stroke.
Executives envision rolling out the new blood test in Europe in the first half of 2013.
BG Medicine's success in gaining European approval contrasts with the regulatory delays the company has faced in the United States. In August, BG Medicine pulled its 510(k) submission for CardioScore, because it failed to meet an Aug. 15 FDA deadline confirming certain study data the company obtained through medical insurance claims. In its CE mark announcement, CardioScore said in a statement that it "is continuing its active discussions with the U.S. Food and Drug Administration regarding 510(k) clearance for the test in the United States."
BG President and CEO Eric Bouvier said in a statement that the CE mark, at least, is a major advance for the company and that CardioScore "will be a pivotal and disruptive game-changer" in the bid to prevent heart attacks and strokes.
"The CardioScore test will identify individuals at elevated risk for attack and stroke, enabling preventative intervention," he said.
The company also has its BGM Galectin-3 test for patients with chronic heart failure, and it's approved both in Europe and the United States. As far as CardioScore goes, plans call for selling the test in Europe "in collaboration with specialty laboratory partners."
- read the release
BG Medicine yanks 510(k) submission for cardiovascular Dx
Positive results for biomarker based diagnostic CardioSCORE