2013 Outlook"The substantial progress we made in 2012 has positioned us to drive commercial growth in 2013 and beyond," Bouvier continued. "Galectin-3 test sales are expected to benefit due to the increase in the number of specialized and regional lab providers with which we have partnered from three to seven, the US sales force targeting customers focused on reducing hospital readmissions in light of recently imposed Medicare penalties and the anticipated continued commercial progress of our IVD partners, bioMerieux and Abbott, in Europe. We also expect to launch the CardioSCORE test in Europe during the first half of 2013 through specialty lab partners, and expect to complete the medical review of data from the BioImage study, which will then guide our regulatory and commercial strategy for CardioSCORE in the U.S."
- In December 2012, BG obtained a CE Mark for the CardioSCORE test, enabling the Company to market the test in Europe and other countries that recognize the CE Mark. The company expects to begin commercial activities in Europe for CardioSCORE in the first quarter of this year.
- In January 2013, bioMérieux obtained a CE Mark in Europe for an automated version of the BGM Galectin-3 test and launched its VIDAS® Gal-3 test in Europe and in certain other territories that recognize the CE Mark. bioMérieux is offering the VIDAS® Gal-3 test through its VIDAS® immunoassay platform, which is comprised of a broad CE-Marked installed base of instruments throughout Europe and in other countries that recognize CE Mark.
- In February 2013, we announced that two studies, comprising over 3,300 subjects, were published in two leading clinical journals that affirmed the clinical significance of repeat testing of galectin-3 in blood using the BGM Galectin-3 assay for patients with chronic heart failure. The results published reveal that changes in galectin-3 levels, over a time frame of 3 to 6 months are of significant clinical importance when they occur. These consistent findings in over 3,300 subjects across three distinct cohorts suggest that periodic testing of galectin-3 in patients with heart failure is useful for identifying patients in whom disease progression is advancing and whose clinical risk profile is changing. Full details are available here: http://investor.bg-medicine.com/releasedetail.cfm?ReleaseID=745705 .
- As previously announced, the BGM Galectin-3 test obtained an analyte-specific CPT code, 82777, in late 2012 for Medicare reimbursement purposes. In addition, we believe several managed care providers, which cover 75% of the US population, are also reimbursing for the BGM Galectin-3 test. We also believe these managed care providers and Medicare collectively represent approximately 140 million covered lives.
- Two 510(k) filings were withdrawn or expired prior to FDA's response deadline because complete responses could not be submitted in time to meet the FDA's deadline dates:
Conference call and web cast The Company will host a conference call and webcast today beginning at 8:30 am Eastern Time. The conference call may be accessed by dialing (877) 845-1016 from the U.S. and Canada, or (708) 290-1155 from international locations. The conference call will also be available via the Internet at www.bg-medicine.com . A replay of the call will be available approximately one hour following the end of the call through March 15, 2013. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, conference ID #15127201. The call will be archived and accessible on the Web site for approximately 30 days.
- Fujirebio, who is developing the ARCHITECT Galectin-3 test (an automated version of the BGM Galectin-3 test) for Abbott withdrew its 510(k). A new 510(k) application is expected to be filed in the second half of 2013 that will address the FDA's questions and comments.
- BG allowed its 510(k) for the BGM Galectin-3 test for the assessment of risk of developing new-onset heart failure (second indication for the BGM Galetin-3 test) to expire. The Company is currently evaluating options for submitting a new 510(k) that will address the FDA's questions and comments.