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MOST OF US THINK of DNA and paternity testing as something we watch on "Who's Your Daddy?" tabloid TV, or witness during our favorite Sunday night crime drama. However, a new, innovative technology for a noninvasive prenatal paternity test has opened a fascinating frontier of DNA testing that moves the science into a new century.

DNA Diagnostics Center (DDC) announced the release of a noninvasive prenatal paternity test. The company has the exclusive license in the U.S., using testing known as SNP (single nucleotide polymorphism--pronounced "snip") microarray technology. The test is safe for mother and fetus, and replaces current invasive methods that can be dangerous to the pregnancy. It employs a bioinformatics program to analyze 317,000 genetic markers, and requires a simple blood draw from the mother and alleged father, with results--99.9% accurate in as little as five days.

Scientists now can--at 12 weeks--analyze all 46 chromosomes necessary to determine paternity. (There is a gender test that can determine the sex of a baby as early as seven weeks. However, it analyzes only one chromosome.)

According to Peter Vitulli, CEO of DDC, "Questions about paternity testing often arise at conception, and are a dilemma for the mother: Can I get a test now? Do I have to wait until the child is born before I determine who is the biological father? Such uncertainty can cause anxiety and maternal stress, which could affect the health of both the mother and child."

Interestingly, almost 50% of those who contact the company are potential fathers, who, along with the mother, find great comfort and closure at an early stage of pregnancy.

The test involves a three-step process: First, a call is made to DDC to speak with a paternity test specialist. Since each situation is unique, it is important to get the right test. If a noninvasive prenatal test is chosen, appointments are made for the blood draw at a collection facility. Next, a small amount of blood is required from the mother and potential father. The mother's blood is stabilized for shipping to the laboratory with a proprietary solution that preserves the fetal DNA for several days at room temperature. This is critical to ensure the integrity of the testing. Finally, the testing is performed and results are delivered. They are available within a week of the samples arriving at the laboratory, and indicate whether the alleged father is the biological father of the child.

Noninvasive prenatal paternity testing has been available for years but, the new test, created by Gene Security Network, represents a significant advancement in accuracy and reliability. "Our bioinformatics technology is used in a range of... clinical diagnostic tests involving tiny quantifies of DNA--as little as that from a single cell," explains CEO Matthew Rabinowitz. "This... technology is now being applied to tiny traces of fetal DNA found in a pregnant mother's blood to reach an accurate conclusion regarding paternity, without incurring any risk to the pregnancy."

What also makes this new test extraordinary is that it uses "circulating cell-free" fetal DNA, ensuring that the fetal DNA analyzed will be from the DNA of the current fetus, and not fingering DNA found in the mother's system from previous pregnancies.

DNA testing for paternity has become the standard for resolving questions about biological relationships. According to the AABB, (formerly known as the American Association of Blood Banks), the organization that accredits laboratories to perform paternity testing, more than 500,000 paternity tests are performed each year in the U.S. Many concern claims for child support and almost all use DNA testing. The reason is twofold. Since DNA is the genetic material unique to each individual, DNA paternity testing relies on the genetic fact that an individual receives DNA from his or her biological parents in equal amounts. Second, DNA paternity testing has the statistical power to establish parentage effectively.

As with any groundbreaking scientific and medical test, DDC's latest effort may attract controversy. For instance, some contend that information about who is the biological father of a developing fetus may lead to an increased number of terminations. "That's a private family matter, which should be discussed confidentially between family members," stresses Vitulli. "DDC is in the business of determining paternity and helping families at the most exciting, yet stressful, time of their lives. It is our hope that the news we provide is a service that helps all family members."

This noninvasive technology is the beginning of a new frontier in DNA testing. As reported in Nature, SNP microarray technology also may have the ability in the near future to detect abnormalities such as Down syndrome and single-gene defects like cystic fibrosis, sickle cell anemia, and Tay-Sachs, as well as other genetic conditions.

Moreover, imagine using the technology to evaluate your own health. Researchers point out that certain biomarkers in the blood can offer a glimpse into a variety of ailments. The advancement of scientific instrumentation and sensitivity make this a possibility. In the near future, a blood sample collected by your physician may unlock even more information about you and your health.

Michael Baird is chief science officer of DNA Diagnostics Center, Fairfield, Ohio, and chair of the Relationship Testing Committee of the AABB responsible for developing standards for paternity testing. He has been involved in more than 300 court cases involving DNA and paternity.
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Title Annotation:HEALTH BEAT; Deoxyribonucleic acid Diagnostics Center
Author:Baird, Michael
Publication:USA Today (Magazine)
Geographic Code:1USA
Date:Nov 1, 2011
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