results, which sort of defeats the purpose, and can lead patients to opt for one of the standard invasive procedures.
As I described back in February, when the Natera test was formally rolled out, it is being marketed for its ability to specifically call out when a fetus has Trisomy 13, 18 and 21, which are otherwise known as Patau syndrome, Edwards syndrome, and Down syndrome, respectively. Natera also says its test can detect monosomy X (Turner syndrome), which doesn’t tend to display clear symptoms in newborns, which can be effectively managed if caught early.
Natera isn’t entering the market alone. It offers its screening test direct to consumers, and through distribution partners that include Quest Diagnostics, Bio-Reference Laboratories, and Arup Laboratories. Especially since the American College of Obstetrics and Gynecology recommendations from last fall, Sheena says the company says it has gotten a “really positive response” from insurers about their willingness to pay for the test. Big private insurers such as WellPoint, United Healthcare, and Aetna have announced policies in favor of non-invasive prenatal tests, and are paying for the tests, including Natera’s.
While Sequenom was the first mover in this market, introducing its test in October 2011, the overall market is still pretty small, and in its early days. If more physicians and insurers embrace the idea of expanding use of the tests to all pregnant women in the U.S., then the market could easily reach into the billions of dollars. That’s not likely to happen anytime soon, but it’s not inconceivable either. If the four companies do end up providing people with valuable information, and no major scandalous mistakes get made with the data in the early days, then you can bet even more investment dollars will line up behind this new frontier for genetic information.
“The big vision at the company is to change the way families approach genetics,” Sheena says. “Non-invasive prenatal testing is a major step toward that.” He adds: “Ensuring that the test is used appropriately, responsibly, effectively, and broadly, is our goal for 2013.”
