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Legal battle threatens access to noninvasive fetal DNA test

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The market for genetic tests that analyze fetal DNA using mom's blood could exceed $1 billion a year. But this commercialization brings legal battles affecting corporate profits and patient access.

Baby genome found in mom’s blood! Ever since scientists made this discovery, genetic tests that analyze fetal DNA from the blood of the mother-to-be have been arriving in a rush.

Until recently, diagnoses on unborn babies could only be done using fetal cells from fluid in the womb (amniocentesis) or placental tissue (chorionic villus sampling). These require inserting needles and tubes into the womb or placenta and can cause miscarriages in 1% of all cases.

So, hooray for noninvasive prenatal screening!
A little history…

Over a decade ago, scientists discovered fetal DNA floating in pregnant women’s plasma (the liquid where blood cells are suspended).

In 2010, scientists developed a way to scan the unborn baby’s genome (pictured) using just a small sample of the mother’s blood by utilizing the fetal DNA floating cell-free in the mother’s plasma. Turns out, the baby’s DNA makes up 10% of the total mix.

NOW, 3 companies have launched their versions of this test in the last year, and another plans to do so later this year. Nature News reports:

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.

The 4 firms are all based in California: Sequenom in San Diego, Ariosa Diagnostics in San Jose, and Verinata Health and Natera, both in Redwood City.

They all use similar techniques, spotting genetic abnormalities as early as 10 weeks after conception (and several weeks sooner than tests in use). For women at high risk of carrying offspring with Down syndrome, the tests produced fewer false positives.

At the core of the conflict: patents. In 2005, Sequenom licensed the method, and it now says that other companies are infringing this patent. In January this year, Sequenom filed a lawsuit against Ariosa, then requested a preliminary injunction to stop the company from using its test. As a result, Ariosa, Natera and Verinata have all sued Sequenom, arguing that the slight differences in their methods mean that they're not infringing on the patent.

This week, a judge from the US District Court of Northern California will hear arguments in the lawsuits, but decisions in the cases aren't expected for many months.

The lawsuits are driven by the promise of a lucrative market that is poised to become a routine part of prenatal care. Observers expect the advantages of the noninvasive tests to expand the pool of women who opt for prenatal genetic screening in the United States each year from fewer than 100,000 to as many as 3 million.

The noninvasive prenatal-testing market could exceed $1 billion a year.

At present, costs range from $795 (for Ariosa's test) to $2,762 (for Sequenom's). Though with insurance coverage and state programs, the costs vary a lot.

If one company has a monopoly on the market, it'll essentially be able to dictate the standard of care and the price of the test. This could potentially push costs out of reach for government programs like California’s Medi-Cal, which pays for 40% of California births each year, or Medicaid, which covers as many as 60% of the births in some states.

Earlier this month, researchers showed that the whole genome sequence of a unborn baby can be reconstructed using just a blood sample from a pregnant woman and saliva from the father-to-be. The reading of whole genomes could tell parents about even more genetic variations. This could cost as much as $50,000.

[From Nature News]

Image: A. Chan & L.W. Yuen, Science/AAAS

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Janet Fang

Contributing Editor

Janet Fang has written for Nature, Discover and the Point Reyes Light. She is currently a lab technician at Lamont-Doherty Earth Observatory. She holds degrees from the University of California, Berkeley and Columbia University. She is based in New York. Follow her on Twitter. Disclosure