Previous Statements by SQNM
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» Sequenom's CEO Hosts Launch of MaterniT21 - Conference Call Transcript
Our Sequenom Center for Molecular Medicine built a 21,000 prenatal and retinal diagnostic test in 2011. I think is important because we now have a revenue to cover our investment in our infrastructure that’s our billing, logistics, medical affairs, and sales force efforts going forward. And we plan to take advantage of that and we have successfully demonstrated that we can obtain reimbursement for this test as well.We have about 350 employees worldwide, and two CLIA labs one in Grand Rapids, Michigan, where we do our MassARRAY; and in San Diego where we do our MaterniT21 test. This is our product portfolio in molecular diagnostics. I think the most important thing here is that we have introduced MaterniT21, and we did that in October. And that we continue to work with the FDA to obtain PMA approval for an LDT test for T21. In December we submitted to the FDA a clinical plan for clinical study for that LDT test. And we continue and expect to have discussions with the FDA in the first quarter of this year. We also introduced our age-related macular degeneration tests and we are seeing some initial success there. In 2010, in January at this meeting and in 2011 in January this meeting, we laid out goals for ourselves for the year, and we during each of those years as we progressed through the year various financial meetings, we kept you apprised at how we are doing in those goals. In both 2010 and 2011 we achieved all of our goals as you can see in the checks in this box. Most important of course is the introduction of the MaterniT21 tests in October and also that we introduced our AMD tests, the RetnaGene LDT. So, in keeping with that tradition, these are the goals we have established for ourselves for 2012, and that we expect to keep you posted on as we go through the year. For our Sequenom business, this is not the molecular diagnostic, we expect to file with FDA a 510-K for our MassARRAY system. We expect to continue to introduce researching (inaudible) for the MassARRAY platform throughout the year.
We also expect that the we present the slow random sequencing pattern or issue in that in 2012. As we have been saying for over a year, we expect to raise capital sometime in 2012 likely in the first half. We at least since base in North Carolina, for a second CLIA lab where we could do the MaterniT21 test. And we expect to have that built out by the end of the year. In 2011 we also licensed LifeCodexx to the patents and technology for our T21 tests in 2012, we expect to have additional licensees established in Europe and we should look for those to appear at various times during the year.For the Sequenom Center for Molecular Medicine, and we have more aggressive goals, we expect to increase our field sales force from current 20 to over 50. Basically doubling the T21 sales force, doubling the AMD sales force, and now that we are allowed to sell T21 in New York State we are going to add additional three reps in New York State. We have established a minimum goal for T21 test to be built of 21,000 for the year. I will speak a little bit more about that later in the talk. We have a goal of having contracts with at least two national payers for reimbursement for T21 during the year. We have submitted and had accepted a paper on the T13 and T18 portions of the women’s and infant study. We expect that to be published in Q1, quite honestly we know that the electronic version of that will be ready and available in four to six weeks. Read the rest of this transcript for free on seekingalpha.com