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Analytics & Data Science Security & Privacy

FDA Opens the Doors for Consumer Genetic Testing, But is the Technology Ready?

Genetic testing is going mainstream, but is the science ready for prime time? The marketing of genetic tests to consumers raises short-term risks and may even threaten the longer-term promise of the technology.   More

Bio & Life Sciences Healthcare

Ethical Issues Abound with Fast-Growing Prenatal Genetic Testing

In the last few years, the standard tests for fetal abnormalities have been largely replaced with new genetic tests. Since they launched, traditional procedures that confer a small risk of miscarriage have dropped by about 70 percent. Now we face a big ethical issue: these tests reveal much more about future diseases than those they replaced. What information should parents know, and what can and should they do about it?   More

Bio & Life Sciences Healthcare

Lawsuit Underscores Risk of Thinking Genetic Tests Authoritative

A recently filed lawsuit suggests trouble may be brewing for the new era of genomic testing. A mother claims an inaccurate test result contributed to the death of her young son, who had a mitochondrial disorder. But interpreting genetic tests remains as much art as science, which we will have to accept if this field is to get on its feet. It would be a shame if such tragedies hindered the innovations that will ultimately make genomic medicine more reliable.   More

Healthcare

My BRCA Journey: Why Fear of Information Imperils Genetic Testing

The world breaks down into two camps, my genetic counselor said: people who want information, and people who don’t. I’ve been writing about gene testing and genomics for a long time, but as I navigated my own recent journey in genetic testing, I learned why that divide will probably remain the biggest hurdle to achieving the promise of genomics. Despite the enthusiasm I hear regularly from genomics experts I talk to about the clinical power of genetic tests, getting my own medical professionals to order the genetic test for BRCA, the mutation linked to breast cancer, was a challenge.   More

Bio & Life Sciences

How You Are Hurt by FDA Genetic Test Restrictions

These are boom times for progress in genetic testing, but restrictions limiting access are delaying benefits we could all be experiencing right now. The National Institutes of Health maintains a Genetic Testing Registry, which currently lists some 15,000 available genetic tests. Together, they can single out 2,800 genes for some 4,000 medical conditions—and that’s not factoring in the rapidly growing exome or genome sequencing tests that look at all known genes. With so many tests out there, there’s a good chance that one exists to scan for whatever diseases may run in your family. But you may not be able to get those tests. Direct consumer access has always been tricky in U.S. medicine, and the FDA’s crackdown on consumer genetic testing firm 23andMe last year has providers running scared.   More