professional regulation

Recent Articles

DIY Gene Editing: Fast, Cheap—and Worrisome

BY AMY DOCKSER MARCUS
WALL STREET JOURNAL

Kian Sadeghi has postponed homework assignments, sports practice and all the other demands of being a 17-year-old high-school junior for today. On a Saturday afternoon, he is in a lab learning how to use Crispr-Cas9, a gene-editing technique that has electrified scientists around the world—and sparked a widespread debate about its use. Scientific breakthroughs often raise big ethical questions. Moral concerns around the 1996 cloning of Dolly the sheep or the 2000 announcement of a rough draft of the human genome still reverberate today. The public benefits from scientific advances, particularly in improving health. Continue Reading →

Filed under:

Genetically Modified Mosquitoes: What Could Possibly Go Wrong?

BY ADRIENNE LAFRANCE
THE ATLANTIC
History is filthy with stories of pest control gone terribly, terribly wrong. Consider, for example, the infamous tale of how the mongoose got to the Hawaiian Islands. The sleek carnivore was imported in the 1880s as part of a plan by the sugar industry to subdue the rats that wouldn’t stop gnawing through stalks of sugar cane. Mongoose do enjoy a tasty rat supper, when the opportunity presents itself, but there was a problem: Rats are active at night, while mongoose are active during the day. So instead of decimating the rat population, the mongoose came to Hawaii and feasted on native birds and their eggs. Continue Reading →

Filed under:

Your Genome Belongs To You

BY SHARON TERRY AND ROBERT COOK-DEEGAN
HEALTH AFFAIRS

Just four years ago, only two people in the world had their genome sequenced:  James D. Watson (co-discoverer of the structure of DNA) and J. Craig Venter (former President of the firm that mounted a private-sector rival to the Human Genome Project).  There are now many thousands of such people.  At genome meetings, scientists are talking about millions of fully sequenced genomes in coming years.  And after that…? It cost roughly a billion dollars to generate the first reference human genome in 2003; last year a company would charge $10,000 for this service.  This year it costs a few thousand dollars. And in a few years we should be able to get our genomes sequenced for a few hundred dollars. At some point, our genomic information will get cheap enough for most of us to take the plunge and “get our genomes done.”  It may be curiosity, or concern about disease risk, or interest in ancestry and biological relationships in the context of social relationships. This seems big and incipient. Continue Reading →

Filed under:

DNA Test Agreements Disregard Privacy

BY MARK ANDERSON
IEEE SPECTRUM

Some personal genomics companies rely on so-called “clickwrap” contracts—agreements to which consumers could one day regret having clicked “Agree.”

Anyone today who spends time in the digital world also enters into contracts in the digital world. And while many consumers today just click through so-called “clickwrap” contracts without reading them, one new study suggests that they take greater caution when clicking “Agree” to the legal terms underpinning, say, a personal DNA test. The new study also leaves the door open for consumer advocates to begin pushing toward stronger consumer standards in personal genome contracts, starting with questioning the very logic of the clickwrap model in the personal genome industry. It’s one thing, after all, to breeze through a lengthy contract when the worst-case scenario is the possible dissemination of, say, your history of iTunes purchases or the contents of your Amazon shopping cart. It’s quite another to blithely risk losing control of parts or the whole of your own genome sequence—arguably the one string of personal data that is both the core of a person’s identity, and a nugget of information that could never be changed if it were compromised. Continue Reading →

Filed under:

Scientists Seek Ban on Method of Editing the Human Genome

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 →

Filed under:

US regulators try to tame ‘wild west’ of DNA testing

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:

23andMe’s First FDA Cleared Test Paves Path for Firm to Launch Other Carrier Reports

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 →

Filed under: