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Genetic tests that analyze fetal DNA from a pregnant woman's blood are arriving in a rush, giving parents powerful tools for gleaning information about their unborn offspring. Three companies have launched versions of such tests in the past 12 months, and a fourth plans to do so later this year.
But the commercialization of these tests has brought a legal battle that could not only affect corporate profits, but also limit which patients will be able to access the tests and under what terms. The tangle of lawsuits may also offer a taste of future conflicts in the rapidly growing medical-genomics industry.
“If a single company has a monopoly on the market, it will essentially be able to dictate the standard of care and the quality of care,” says Mildred Cho, a bioethicist at the Stanford University School of Medicine in California.
The four firms are all based in California — Sequenom in San Diego, Ariosa Diagnostics in San Jose, and Verinata Health and Natera, both in Redwood City — and use similar techniques to identify fetal DNA in maternal...