A new genetic test for Down syndrome is put on hold — most likely on temporary hold.
Technological advancements have afforded many benefits to the pro-life cause. Ultrasound imaging has revealed the child in the womb as a living, feeling human being, and at earlier stages than previously thought possible. The widespread use of such technology helps explain significant shifts towards the pro-life position — both in sentiment and in deed, especially among young Americans — over the last fifteen years.
But medical technology has had some negative effects, too, especially for unborn babies with disabilities. Ultrasound imaging is routinely employed to discern genetic abnormalities in unborn children and to end the lives of those who fail to meet the standards of a culture that increasingly views genetic perfection as an entitlement.
This month, Sequenom, a company that makes genetic analysis products, was set to release a new genetic test for Down syndrome. The test, called SEQureDX, has been hailed by some as “the Holy Grail of genetic testing,” because it is safer and more accurate than any previous prenatal genetic test. But once it hits the market, SEQureDX may become known for something far less inspiring: as a leading tool for the elimination of an entire class of people.
Currently, prenatal genetic testing involves a combination of blood tests and ultrasounds to determine whether an unborn child faces significant risk of having a disability. Some women undergo further testing to confirm or rule out a diagnosis. The most common test in amniocentesis, in which amniotic fluid is extracted from the amniotic sac surrounding the baby. Fetal DNA in the tissue contained in the fluid is then examined for genetic abnormalities.
But many women eschew amniocentesis. Not only must amniocentesis wait until the second trimester of pregnancy, but it also carries a significant risk of miscarriage (as high as 2 percent) and risks causing fetal abnormalities, pre-term birth and fetal trauma.
The new tests, including SEQureDX, are less invasive, more accurate and can detect a broader range of fetal conditions with more sophisticated blood tests that examine a baby’s genetic information in DNA that circulate in the mother’s bloodstream.
Though the new tests are safer for both mother and child, they will create a profoundly unsafe environment for babies who test positive for genetic abnormalities.
Surveys have shown that as many as nine out of 10 babies with Down syndrome are aborted once their disability is detected. Even using the more invasive prenatal genetic testing, the number of Down syndrome live births declined 7.8 percent between 1989 and 2001, according to a study published in the American Journal of Obstetrics and Gynecology.
But the number of babies born with disabilities could plummet once the new tests become available, and as more physicians begin to follow the advice of the American College of Obstetricians and Gynecologists (ACOG), which in 2007 recommended universal screening for Down syndrome.
All of this worries pro-life and disability rights advocates, who fear what may result when such tests are put in the hands of a medical establishment with a decidedly anti-life bias against disability. In a recent article in the Journal of the American Medical Association, Peter A. Benn and Audrey R. Chapman argue that the new tests raise “significant ethical issues,” which will require an “ill-prepared medical system to change how patients are counseled and how cases are managed.” Benn and Chapman call for oversight of genetic testing by the United States Food and Drug Administration.
A further fear is that screening for disability and disease in unborn children will lead to widespread use of techniques that allow couples undergoing fertility treatments to create embryos and select both gender and physical traits in a baby. Pre-implantation genetic diagnosis, or PGD, allows parents to create designer babies by screening and then destroying embryos determined to have higher risk of severe genetic conditions. So parents can screen embryos that are the “wrong” sex, or that have the “wrong” eye or hair color, height and other physical traits in what the director of one clinic in Los Angeles calls “cosmetic medicine.”
Polls show most Americans oppose genetic testing for cosmetic enhancement (one poll found about 10 percent of respondents supported genetic testing for athletic ability). But there is potential for it to catch on, especially since, even though PGD is banned in many other countries, it is completely unregulated in the United States.
Also, polls show public support for abortion is strongest when testing indicates a high likelihood of fetal abnormality. That explains why Sequenom’s CEO, Harry Stylii, believes the market for prenatal testing for chromosomal disorders like Down syndrome could be $3 billion to $5 billion or more worldwide. It also explains why shares of Sequenom increased 200 percent in 2008 after the company revealed successful early testing of SEQureDX.
But recent developments may delay the impending epidemic of disability abortions caused by enhanced genetic testing. In February, due to “mishandling” of data by employees, Sequenom revised downward the results of its initial tests, re-estimating the accuracy of SEQureDX from 99.9 percent to 96.6 percent.
Then, in May, five investors filed suit against Sequenom for issuing materially false and misleading statements about the accuracy of its Down syndrome test. That followed an April 29th announcement that the company would delay launching SEQureDX in order to review all test data.
None of this means unborn babies with disabilities will be granted an extended reprieve. Sequenom says it wants to have a validated test by the fourth quarter of 2009 and new tests launched by late 2010 or early 2011. And at least three other companies are developing similar genetic tests and hope to have them on the market by the end of the year.
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