BY NICHOLAS WADE
THE NEW YORK TIMES
A group of leading biologists on Thursday called for a worldwide moratorium on use of a new genome-editing technique that would alter human DNA in a way that can be inherited. The biologists fear that the new technique is so effective and easy to use that some physicians may push ahead before its safety can be assessed. They also want the public to understand the ethical issues surrounding the technique, which could be used to cure genetic diseases, but also to enhance qualities like beauty or intelligence. The latter is a path that many ethicists believe should never be taken. “You could exert control over human heredity with this technique, and that is why we are raising the issue,” said David Baltimore, a former president of the California Institute of Technology and a member of the group whose paper on the topic was published in the journal Science. Continue Reading →
professional regulation
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US regulators try to tame ‘wild west’ of DNA testing
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BY ERIKA CHECK HAYDEN
NATURE
Genetic testing has entered a new realm, with the ability to read a person’s genetic code and predict how it will affect his or her health. But US regulators are struggling to work out how the tests should be governed, with a particular sticking point being who decides what the genetic read-outs mean in terms of health and disease. So far, the US Food and Drug Administration (FDA) has approved genetic tests only for specific conditions. This includes the approval on 19 February of a test developed by 23andMe of Mountain View, California, to determine whether people carry a gene variant that could lead to their offspring developing Bloom syndrome, a rare disorder characterized by small stature and multiple health problems.
With the massive number of genome-based diagnostics that are possible, the agency cannot practically continue with the painstaking approach it has taken in approving these tests. So on 20 February, the FDA is running a workshop at which scientists, doctors and regulators will discuss a strategy put forward by the agency in December that aims to allow the technology to flourish but clamp down on a ‘wild west’ atmosphere in which some companies are making unproven claims about how well the tests can predict health patterns. Continue Reading →
Filed under: professional regulation
23andMe’s First FDA Cleared Test Paves Path for Firm to Launch Other Carrier Reports
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BY TURNA RAY
GENOMEWEB
The US Food and Drug Administration’s clearance last week of 23andMe’s Bloom syndrome test has created a more predictable path for the genomics firm to launch a direct-to-consumer (DTC) carrier testing offering in the near term. As part of the authorization, the FDA said it is classifying carrier screening tests as class II, and intends to exempt similar devices from FDA premarket review. FDA’s action shows its regulatory flexibility as it is coming under significant criticism for its draft guidelines for regulating lab-developed tests (LDTs), a plan that lab industry players say will hinder diagnostics innovation and patient access to tests. The agency has said it will regulate DTC genetic tests outside of its LDT regulatory framework. However, its handling of 23andMe’s first 510(k) application – for a carrier test for a rare, autosomal recessive genetic disorder – shows its ability to lightly wield its regulatory authority for diagnostics that it finds pose intermediate risk (deemed class II in a three-class risk system) to patients. Continue Reading →