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BG Medicine's Q3 Revenues Shoot up 83 Percent, Plans FDA Submissions

NEW YORK (GenomeWeb News) – BG Medicine today reported an 83 percent jump year over year in third-quarter revenues and progress in its plans to file for regulatory approval of its tests.

The Waltham, Mass.-based company posted $179,000 in revenues for the three months ended Sept. 30, up from $98,000 a year ago, which it attributed to an increase in sales of its galectin-3 test.

Its R&D costs for the quarter rose 12 percent year over year to $1.9 million from $1.7 million due to an increase in activity and personnel costs associated with its biomarker discovery and development research.

The firm's SG&A costs spiked 72 percent to $3.1 million from $1.8 million a year ago due to educational programs associated with its galectin-3 test, as well as increased costs from being a public company. BG Medicine went public in February.

BG's net loss for the quarter rose to $4.9 million, or $.25 per share, from $4.5 million, or $1.59 per share, a year ago. About 19.3 million shares were used to calculate loss per share in the recent quarter, compared to 3 million shares used in the year-ago period when the firm was privately held.

As of Sept. 30, BG Medicine had $13.1 million in cash and cash equivalents, and $14.2 million in marketable securities.

In a statement, the firm said that recent highlights included the launch of galectin-3 testing by Cleveland HeartLab a week ago. It also reported progress in its collaboration with the Framingham Heart Study "regarding the galectin-3 study on the FHS offspring cohort" and use of the data for a planned submission to the US Food and Drug Administration for expanded use of the galectin-3 test.

BG Medicine additionally said that an undisclosed partner had progressed in developing an automated version of the test, and that the partner intends to submit to an application to US regulators in the first quarter of 2012.

The company is developing an in vitro diagnostic multivariate index assay to identify patients at high risk for a heart attack or a stroke within a two- to four-year period. Today, it said that it has begun testing more than 6,500 samples for a validation study for the assay called AMIPredict, and the laboratory phase of the study is anticipated to be completed sometime this month.

It is nearing completion of the analytical study for the test, as well, and is preparing study reports and other documents in support of a premarket approval submission to FDA in December for AMIPredict, it said.

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