BG Medicine yanks 510(k) submission for cardiovascular Dx

BG Medicine ($BGMD) pulled the 510(k) submission for its CardioScore diagnostic test this week because it couldn't meet an FDA deadline for requested information, and investors punished the company in turn. Of course, widening 2012 second-quarter losses didn't help matters.

As the Boston Business Journal and others reported, the Waltham, MA-based diagnostics company saw its stock price drop about 6% on the negative news, before slightly rebounding to $6.49 per share at the end of trading on Aug. 9.

BG Medicine said it withdrew its 510(k) application for its CardioScore blood test for cardiovascular disease because it didn't meet an Aug. 15 FDA deadline to confirm certain study data obtained through medical insurance claims. The company was careful to note that its approach is "a method previously validated in numerous peer-reviewed studies." No new submission data is planned yet, the company said, until it is "satisfied that the information requested by the FDA is addressed in the new submission."

Meanwhile, BG Medicine noted, it is plowing ahead with expansion plans for the company's BGM galectin-3 heart failure diagnostic test franchise. A separate 510(k) submission is pending for the company's Architect galectin-3 assay, and another 510(k) process is underway to gain expanded clearance to use the BGM galectin-3 test for adult patients at risk of developing heart failure based on elevated galectin-3 levels (an expansion already obtained in Europe through a CE mark). Development partner Abbott ($ABT), meanwhile, is expected to obtain a CE mark in the coming months for an automated version of the BGM galectin-3 test for Europe.

BG Medicine said it lost $6.4 million during the quarter ending June 30, up from a $4.8 million net loss over the same period in 2011, driven in part by higher sales and administrative expenses. As of the end of the second quarter, BG Medicine said it had about $23.3 million in cash, equivalents and securities on hand. BG Medicine just went public last year, and is still ramping up revenue. One bright spot: Product revenue spiked in the second quarter to $566,000, up from $46,000 over the same period in 2011, reflecting increased demand for the BGM galectin-3 test.

- read the release
- check out the BBJ's take
- here's BioCentury's coverage

Special Report: BG Medicine - Biotech IPOs of 2011

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