for the Sequenom test, although it gives Sequenom the confidence to move full throttle on a more ambitious development program, Stylli says. The company also is laying groundwork for the market launch by generating interest among physicians, and making it easier to recruit patients to clinical trials, he says.
What that means is the ultimate data that will decide whether this diagnostic is a hit will start coming out later this year. One trial, called LDT, is being conducted among 3,000 to 5,000 pregnant women. That study, assuming it is also positive, will be used to bolster SEQureDx’s market introduction in June, and full results should be published in a peer-reviewed journal in 2010, Stylli says.
Another study, called the “RNA” trial, will provide much more evidence, from 10,000 patients. The first peer-reviewed publication on that study is scheduled to appear in the fourth quarter of this year, Stylli says.
This certainly intrigues Wall Street analysts, like Piros, who projected in October that Sequenom shares could be headed to $65 on this opportunity. But doctors are a different story. The American College of Obstetricians and Gynecologists currently recommends that all women get a prenatal screen for Down’s, although they don’t specify which one. That is an important endorsement Sequenom wants to win, and it probably won’t come until 2010 or 2011, Stylli says. The medical audience will demand evidence published in peer-reviewed journals, and loads of it, before they give their full stamp of approval.
“They’re opening the door, but they haven’t let us in yet,” Stylli says.
