Upcoming milestones include:
- We expect our partner, Abbott, to obtain CE Mark and launch its automated version of the BGM Galectin-3 test in Europe.
- We expect to conclude one or more new distribution agreements to launch the BGM Galectin-3 test in additional important markets throughout the world.
- We expect final approval and pricing for the analyte-specific CPT code for the BGM Galectin-3 test, effective for the 2013 Clinical Laboratory Fee Schedule.
- We expect that the results and analysis of the BioImage study, which was used as the clinical validation study for the CardioSCORE test, will be presented at a major scientific conference.
- Finally, for the CardioSCORE test, we are continuing our discussions with the FDA and we look forward to providing an update on the expected timing for the re-filing of our 510(k), as well as our plans for the commercial launch of the product.