FDA Bans 23andme Personal Genetic Tests
By BBC,
BBC News [Quotes CGS's Marcy Darnovsky]
| 11. 26. 2013
Google-backed 23andme has been ordered to "immediately discontinue" selling its saliva-collection tests after failing to provide information to back its marketing claims.
The tests aims to show how personal genetic codes may affect future health.
The company said it would address concerns.
The start-up has been operating since 2006 and was co-founded by Anne Wojcicki, the wife of Google co-founder Sergey Brin.
For $99 (£61), users receive a kit allowing them to take sample of saliva. This is sent to the company and in return users receive a readout of their genetic code.
The website promises reports on 254 health conditions and traits as well as offering to help people trace their genealogy.
Under FDA rules, the company must provide proof about how accurate its detection methods are as well as supplying the error rates from its personal genome service (PGS).
In a public letter the FDA said that 23andme had not supplied this information, despite increasing its marketing campaign and the scope of its tests.
"FDA is concerned about the public health consequences of inaccurate results from the PGS...
Related Articles
By Aileen Editha, The Conversation | 12.11.2024
By Staff, Reuters | 12.04.2024
The Centers for Medicare & Medicaid Services said on Wednesday it had entered into agreements with Vertex Pharmaceuticals (VRTX.O), opens new tab and bluebird bio (BLUE.O), opens new tab to help increase patient access to their gene therapies.
The so-called...
By Staff, Center for Food Safety | 12.03.2024
Photo by Markus Winkler on Unsplash
SAN FRANCISCO—In a precedential victory for food and environmental safety, a federal district court ruled today that genetically engineered (GE) organisms must be regulated. The Court's ruling overturns the 2020 rule overhaul by the...
Image by Mohamed Hassan from Pixabay
It is hard to make predictions, especially about the future, as Yogi Berra, Niels Bohr, and other luminaries have remarked. But there are already signs that the incoming Trump administration may have some difficulty establishing consistent policies about controversial issues concerning human reproduction.
On the one hand, consider “the conservative blueprint for a second Trump administration.”
The notorious Project 2025’s Mandate for Leadership seeks to delete terms such as “reproductive rights” from “every federal...