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BG Medicine (BGMD) Pulls FDA 510(k) Submission for CardioScore Test


8/10/2012 8:33:42 AM

Boston Business Journal by Julie M. Donnelly, Reporter

BG Medicine, Inc. (BGMD), the maker of an FDA-approved diagnostic test for heart failure, saw its shares fall almost 6 percent Thursday. This followed the company reporting that its second quarter loss widened on increased costs, and the company withdrew a diagnostic test from FDA consideration .

The Waltham, Mass-based diagnostics company reported a net loss of $6.4 million in the most recent quarter, compared with a loss of $4.8 million for the quarter ended June 30, 2011. Revenues for the second quarter were $622,000, up from $221,000 in the corresponding period last year.

Selling, general and administrative expenses for the quarter ended June 30, 2012 increased to $4.3 million from $2.5 million during the same quarter ended June 30, 2011. Marketing expenses increased $701,000, due to marketing activities and other costs associated with commercialization support for the BGM Galectin-3 test, which has already been approved by the FDA. General and administrative expenses increased $1.1 million primarily due to personnel-related costs, the company said..

BG Medicine said it has been in continuing discussions with the FDA over the approval process for its CardioScore test, after the regulatory agency said it needed confirmation of certain data obtained through medical insurance claims. The company disclosed in its earnings report that it would not be able to meet the FDA’s August 15 deadline to provide the additional information, and withdrew the application for approval. The company plans to re-submit the application when it has all necessary documentation.

BG Medicine’;s stock was trading at $6.50 on Thursday afternoon, down from $6.90 at the previous close.




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