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.
Three months ended June 30, 2012
Product revenue for the quarter ended June 30, 2012 increased to $566,000 from $46,000 in the quarter ended June 30, 2011, reflecting increasing demand for the BGM Galectin-3 test. On a sequential quarterly basis, product revenue increased 36% to $566,000 from $416,000 in the quarter ended March 31, 2012. Service revenue decreased to $56,000 in the quarter ended June 30, 2012 from $175,000 in the corresponding period in 2011. Our service revenue consists primarily of activities under the HRP initiative.Research and development expenses for the quarter ended June 30, 2012 decreased to $2.1 million from $2.4 million in the quarter ended June 30, 2011. The decrease in expense was due to lower activity associated with the HRP initiative. On a sequential quarterly basis, research and development expenses decreased to $2.1 million from $3.0 million in the quarter ended March 31, 2012.