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Sequenom Eyes 25K T21 Tests Billed in 2012

SAN FRANCISCO (GenomeWeb News) – Sequenom officials today said that the firm's Center for Molecular Medicine has billed for more than 1,000 MaterniT21 tests since its launch in mid-October, and Chairman and CEO Harry Hixson said the firm's goal is to bill 25,000 T21 tests in 2012.

The firm launched the long-awaited trisomy 21 test following the publication of clinical data in a peer-reviewed journal. It has since targeted 20 major metro centers in selling the test and has placed an initial emphasis on gaining reimbursement from private payers. But, company officials said today that they also are making headway with state Medicaid programs and HMOs that require prior authorization.

Speaking at the JP Morgan Healthcare Conference, Hixson said that as part of Sequenom's efforts to reach the goal of 25,000 tests this year, the company has plans to double the sales staff of the CMM to 50 reps.

In addition, the firm said earlier this week that it has received New York State approval to process T21 samples from residents of the state. In light of this, Sequenom also will add a few representatives targeting the state.

Hixson reiterated the company's expectation that a study demonstrating the use of its sequencing-based approach for diagnosing trisomy 13 and 18 will be published in a journal this quarter.

As the firm gears up for an application with the US Food and Drug Administration and continues its development plans, it is going to need a cash infusion. It finished its third quarter at the end of September with $101.2 million in cash, cash equivalents, and investment securities, but Hixson said today that the company would seek to raise capital in the first half of this year.

Asked about the increasing number of startups that are developing sequencing-based, non-invasive T21 tests and the intellectual property landscape, Hixson said he believes any competitors that enter the market will be infringing the IP, US Patent No. 6,258,540, licensed by Dennis Lo to Sequenom.

He said that Sequenom has sent letters to those potential competitors and noted that some have responded by filing lawsuits seeking a judgment that their IP doesn't infringe the '540 patent.

Natera and Aria Diagnostics are the two firms Hixson was referencing. Both firms filed their suits in recent weeks.

Hixson declined to comment further on any of the litigation.

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