Genetic Testing Should Adhere to Medical, Not Business, Ethics: FDA's Regulation of 23andMe Is a Welcome Move for Consumers
By Karuna Jaggar,
Huffington Post
| 12. 01. 2013
This week the Food and Drug Administration (FDA) issued a
warning letter to the direct-to-consumer genetic testing company 23andMe, demanding that it immediately stop marketing and selling its DNA testing service until it receives approval from the agency tasked with regulating medical tests and devices. In what has widely been called a "scathing" letter, the FDA said that 23andMe had failed to show that "the firm has analytically or clinically validated the [23andMe Saliva Collection Kit and Personal Genome Service] for its intended uses" and expresses concern "about the public health consequences of inaccurate results from the P.G.S. device."
It sounds temptingly light-hearted to find out about the percentage of genes you share with a Neanderthal, your earwax type, or why you love Brussels sprouts while others can't stand them. But 23andMe's test doesn't stop there. It claims to provide health reports on some 254 diseases and conditions. Some of the information the company provides, based on the saliva you send them, includes how your body may metabolizes certain pharmaceutical drugs, an individual's carrier status, and risk of disease such...
Related Articles
By Eric Schmidt, TIME | 04.16.2024
Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could...
By Harold Brubaker, The Philadelphia Inquirer | 04.04.2024
Acompany started by University of Pennsylvania scientist Jim Wilson has received FDA approval to test a form of gene editing in infants for the first time in the United States, the company said Thursday.
The Plymouth Meeting company, iECURE, is...
By Carey Gillan, UnSpun | 03.18.2024
A Mexican standoff with the United States turned into a Mexican smack-down this month with the release of Mexico’s formal rebuttal to US efforts to overturn limits Mexico has ordered on the use of genetically modified (GM) corn and the...
By Billy Perrigo, TIME | 03.11.2024
The U.S. government must move “quickly and decisively” to avert substantial national security risks stemming from artificial intelligence (AI) which could, in the worst case, cause an “extinction-level threat to the human species,” says a report commissioned by the U.S...