BG pulls FDA submission for CardioScore, reports poor Q2 earnings
Amid its second quarterly results announcement, BG Medicine said that it is withdrawing the CardioScore diagnostic test from the FDA 510(k) submission process.
The FDA, according to the Waltham, Mass.-based company, requested that BG Medicine conduct an adjudication process to confirm certain data from the BioImage validation study. “The data were originally obtained through medical insurance claims, a method previously validated in numerous peer-reviewed studies,” Eric Bouvier, president and CEO of BG Medicine, said in a release. “Due to the time involved in the adjudication process, we determined that we would not be able to submit a complete response by the Aug. 15, 2012 deadline. Therefore, we withdrew the 510(k) on Aug. 8.”
Bouvier added, "We have been continuing our dialogue with the FDA regarding the 510(k) submission for our CardioScore test. We intend to submit a new 510(k) as soon as we are satisfied that the information requested by the FDA is addressed in the new submission. We remain very confident about the performance of the CardioScore test, and the submission of a thorough and responsive 510(k) is one of our highest priorities.”
For the 2012 second quarter ending June 30, the company reported a consolidated net loss of $6.4 million compared with a consolidated net loss of $4.8 million for the quarter ending June 30, 2011.
Also, research and development expenses for the six months increased to $5.1 million from $4.1 million over the first six months of 2011. BG Medicine said the increase was due to activity associated with its internal biomarker discovery and development efforts, primarily related to the BGM Galectin-3 test and CardioScore test programs.
In July 2012, the company announced the filing of a 510(k) for regulatory clearance for the Architect galectin-3 assay, which is used with Abbott's fully automated Architect immunochemistry instrument platform.
“We filed a 510(k) to extend the cleared labeling indication for the BGM Galectin-3 test to include individuals in the general adult population who are at risk for developing heart failure based on elevated levels of galectin-3,” Bouvier said. “We obtained CE Mark in the European Union for this expanded indication for the BGM Galectin-3 test and we are working with our partners to begin commercialization.”
The FDA, according to the Waltham, Mass.-based company, requested that BG Medicine conduct an adjudication process to confirm certain data from the BioImage validation study. “The data were originally obtained through medical insurance claims, a method previously validated in numerous peer-reviewed studies,” Eric Bouvier, president and CEO of BG Medicine, said in a release. “Due to the time involved in the adjudication process, we determined that we would not be able to submit a complete response by the Aug. 15, 2012 deadline. Therefore, we withdrew the 510(k) on Aug. 8.”
Bouvier added, "We have been continuing our dialogue with the FDA regarding the 510(k) submission for our CardioScore test. We intend to submit a new 510(k) as soon as we are satisfied that the information requested by the FDA is addressed in the new submission. We remain very confident about the performance of the CardioScore test, and the submission of a thorough and responsive 510(k) is one of our highest priorities.”
For the 2012 second quarter ending June 30, the company reported a consolidated net loss of $6.4 million compared with a consolidated net loss of $4.8 million for the quarter ending June 30, 2011.
Also, research and development expenses for the six months increased to $5.1 million from $4.1 million over the first six months of 2011. BG Medicine said the increase was due to activity associated with its internal biomarker discovery and development efforts, primarily related to the BGM Galectin-3 test and CardioScore test programs.
In July 2012, the company announced the filing of a 510(k) for regulatory clearance for the Architect galectin-3 assay, which is used with Abbott's fully automated Architect immunochemistry instrument platform.
“We filed a 510(k) to extend the cleared labeling indication for the BGM Galectin-3 test to include individuals in the general adult population who are at risk for developing heart failure based on elevated levels of galectin-3,” Bouvier said. “We obtained CE Mark in the European Union for this expanded indication for the BGM Galectin-3 test and we are working with our partners to begin commercialization.”