Several tests are now available that can analyse fetal DNA present in a pregnant woman's blood.
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Genetic tests that analyse 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 blood samples. The tests can spot genetic abnormalities, such as those that cause Down's syndrome, as early as ten weeks after conception several weeks sooner than tests already in use. In studies of women at high risk of carrying offspring with Down's syndrome, the tests also produced fewer false positives.
Patents are at the core of the conflict (see 'Blood feuds'). Sequenom licensed the method for detection of cell-free fetal DNA in a mother's bloodstream in 2005, and it now says that other companies are infringing this patent.
A spate of prenatal DNA tests has brought with it a host of legal disputes.
14 OCTOBER 2005
Sequenom licenses a patent for non-invasive prenatal diagnosis.
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Fetal tests spur legal battle