NEW YORK (GenomeWeb News) – Sequenom is closing in on a potential fourth-quarter launch of its Trisomy 21 test and is gearing up with new salesforce hires, according to a research note put out today by an investment analyst.
According to David Ferreiro at Oppenheimer, Sequenom has submitted a clinical validation study on the SensiGene T21 test for publication and plans to hire 20 sales representatives by the end of August, suggesting that the San Diego-based firm is poised to launch the test by the end of 2011 or the start of 2012, on schedule with previous estimates.
Last month, Harry Hixson, chairman and CEO of Sequenom, told investors at a conference that pending a publication of its clinical validation study, the company would launch the test as a laboratory-developed test. At the time, he also gave a timeline for the launch as the end of this year or early 2012.
In discussions with members of Sequenom's management team this week, Ferreiro said that in addition to hiring a 20-strong sales force for the T21 test, the company said that through consultants it has targeted 28 payors for reimbursement of the test, of which 25 have responded, "and their initial receptiveness to the locked assay data is encouraging. Moreover, management indicated they are happy with current pricing sensitivities and continue to believe data quality will help dictate a test price near," the price for an amniocentesis, between $1,500 and $3,000.
Hixson said a month ago that Sequenom was talking with the US Food and Drug Administration about a proper design of a clinical study for submission of the test for pre-market approval. In his note, Ferreiro said that the company is still eyeing a PMA submission for SensiGene T21 in the fourth quarter of 2012.
Sample collection for the PMA is ongoing, but Sequenom and FDA have not agreed upon a trial protocol, he said.
Ferreiro pegged the initial market opportunity for the test at more than $1 billion. Further out, the potential for the test in the low-risk market could increase market opportunity, he added.