BG Medicine gets FDA blessing for automated chronic heart failure test

Abbott's Architect analyzer--Courtesy of Abbott

BG Medicine ($BGMD) got an FDA nod for an automated version of its test for chronic heart failure, a win for the company as it charges ahead with development after laying out some cost-cutting measures last fall.

Regulators cleared the company's Architect galectin-3 test for use in clinical evaluations to see whether a patient is at risk of developing chronic heart failure. Higher levels of galectin-3 in the blood are linked with a more aggressive form of heart failure, and the test could help identify high-risk patients sooner to improve patient care, BG Medicine said in a statement. The company is developing the product with partner Abbott ($ABT) and will run the test on Abbott's automated immunoassay analyzer.

"We believe that the introduction of automated galectin-3 testing will improve access to galectin-3 testing, shorten turnaround time for delivery of test results and, as a result, accelerate adoption of galectin-3 testing in the United States," BG Medicine CEO Dr. Paul Sohmer said in a statement.

The clearance marks a bright point for the company, which is still rebounding from a corporate overhaul unveiled last fall. In September, BG Medicine announced that it would lay off half its workforce to prepare for the commercial launch of automated versions of its galectin-3 test. The move, which eliminated the company's sales and marketing department, was supposed to cost BG Medicine about $300,000 at first but save it $1.9 million in employee salary and benefits annually.

In the meantime, BG Medicine is forging ahead with nonautomated versions of its product. The company's galectin-3 test is already approved in the U.S. and Europe. In 2013, BG Medicine scored another win for its product after the Centers for Medicare and Medicaid Services said it would nearly double its reimbursement for galectin-3 from $17.80 to $30.24. The Waltham, MA-based company also counts CardioDx, a blood test for cardiovascular disease, among its offerings. But its bread-and-butter business is galectin-3.

Still, BG Medicine faces competition from other med tech outfits developing related products. Companies such as Critical Diagnostics and Ireland's Trinity Biotech are hard at work on heart failure diagnostics, chalking up regulatory approvals and touting promising clinical data for their tests. In September, Trinity nabbed a CE mark for its heart failure point-of-care diagnostic. In March, Critical Diagnostics grabbed the China Food and Drug Administration's clearance for its cardiac biomarker test, helping the company cash in on the country's fast-growing diagnostics market.

- read BG Medicine's statement

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