Genetic Testing Boom Ahead?

After 13 years of Congressional debate, the Genetic Information Nondiscrimination Act (GINA) finally was signed into law last month.

This landmark legislation removes a significant barrier to genetic testing by protecting Americans from discrimination based on their individual genetic profiles.
Health insurers will be prohibited from denying coverage or increasing premiums based solely on genetic predisposition toward a specific disease. Employers will not be allowed to consider genetic information when making decisions about hiring, placement, promotion and firing.
"Americans can finally take advantage of the tremendous potential of genetic research without the fear that their own genetic information will be used against them," said Representative Louise Slaughter (D-NY), who first introduced the legislation in 1995. Cosponsor of the bill, Senator Edward Kennedy (D-MA), said, "This bill paves the way for every American to benefit from the vast potential of this new age of personalized medicine."
Will GINA unleash a boom of genetic testing and therapies?
Not immediately. GINA's health-insurance provisions are predicted to take effect in about one year, followed by the employer provisions six months later.
In the meantime, commercial genetic testing labs and manufacturers of in vitro diagnostic (IVD) products may accelerate their efforts in anticipation. The most recent issue of IVD Technology stated, "Industry analysts believe GINA will remove public apprehension about getting genetic tests, which will encourage IVD manufacturers to continue developing such tests."
According to the Genetics and Public Policy Center at Johns Hopkins University, tests currently exist for nearly 1,500 diseases and conditions. Many are available to consumers on the Internet. 
That raises the question as to what people can actually do with the information they gain from genetic testing. Doctors can monitor patients and begin diagnostic and preventive care earlier to save lives. They can also more accurate determine dosages of certain medications, such as blood thinners.  Couples with hereditary conditions can make decisions about having children. And people genetically predisposed toward a disease can learn about it and make long-term medical, personal, legal and financial plans.
The present value of genetic testing has been put in perspective by Francis Collins, director of the Human Genome Project. He explained, "Genetic testing offers us a great opportunity to practice preventive medicine in a way that focuses more specifically on what each of us ought to do for our health. It is a great new model, but right now we don't quite know how to implement it."
Do I believe that GINA will generate a genetic testing boom? Not yet. In the short term I predict:
• A bit of a "gold rush" by companies selling direct-to-consumer tests
• More scrutiny and regulation of genetic test procedures and results
• Continuing debate over "civil rights" regarding genetic information
• More doctors prescribing and more patients accepting genetic tests
• Optimism and opportunity to strengthen the emerging IVD industry
• Healthcare organizations touting their capabilities in genetic testing
GINA is a great leap forward on the road to personalized medicine and the wondrous possibilities of genetic therapies. 
—Tom DeSanto
Photo: www.whitehouse.gov

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