How FDA and 23andMe Dance Around Evidence That Is Not There

by jeeg 28. January 2014 22:02
On July 20, 2010, Andrew Alexander, founder and director of easyDNA, received a letter from the US Food and Drug Administration. The FDA had noticed that easyDNA was marketing the "Genetic Predisposition Health Test, a home-use device that is intended to allow individuals to discover whether t... [More]

The FDA Is Not Anti-Genetics

by jeeg 22. January 2014 21:54
When the FDA shut down biotech company 23andMe’s direct-to-consumer Personal Genome Service, many in the biotech community worried that the FDA was risking the survival of a nascent industry that would revolutionize medical care with new genetic technologies. But lost in the story about ... [More]

Genetic Testing Should Adhere to Medical, Not Business, Ethics

by jeeg 2. December 2013 23:24
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 a... [More]

Consumer gene tests poised for regulatory green light

by jeeg 11. September 2012 20:34
When US lawmakers hauled direct-to-consumer (DTC) genetic testing companies into congressional hearings in July 2010, it seemed clear that the industry was in for a shakedown. The US Food and Drug Administration (FDA) had already mailed stern letters to 20 different firms warning that their genetic ... [More]

Direct-to-Consumer Genetic Tests Neither Accurate in Their Predictions nor Beneficial to Individuals, Study Suggests

by jeeg 31. May 2011 18:27
Direct-to-consumer (DTC) genetic tests give inaccurate predictions of disease risks and many European geneticists believe that some of them should be banned, the annual conference of the European Society of Human Genetics heard May 31. In the first of two studies to be presented, Rachel Kalf, ... [More]

FDA warns home genetic test makers on medical claims

by jeeg 18. May 2011 02:12
The FDA warns a trio of companies that offer direct-to-consumer genetic tests on medical claims made in their marketing campaigns. The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn't approved. ... [More]

Test lets genome out of the bottle

by jeeg 29. March 2011 22:00
PEOPLE are being encouraged to ''discover your own genome'', with the introduction by a Sydney company of an international online DNA testing service for genetic risks to a wide range of common diseases. The tests scan a person's genome and can identify more than 700,000 genetic variants ... [More]

FDA Panel Hearing Suggests Medical Professionals May Play Role in Direct-to-Consumer Testing

by jeeg 22. March 2011 23:17
A role for professionals in direct-to-consumer (DTC) genetic tests seemed like a forgone conclusion from an FDA hearing held two weeks ago, considering the agency first weighed in on the issue last spring. In May 2010, Walgreens backtracked from plans it announced two days earlier to sell a sa... [More]

DTC Genetic Testing Industry and its Supporters Fail to Discredit Damning GAO Report

by jeeg 17. March 2011 18:24
Former FDA official Mary Pendergast, who now works as an adviser to some companies that seek to market genetic tests, raised eyebrows at an FDA hearing on regulation of direct-to-consumer genetic testing when she made some startling claims about the veracity of a damning GAO report which ... [More]

FDA Panel Says Home Gene Tests Need MD Input

by jeeg 11. March 2011 23:43
Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist, an FDA advisory panel recommended. So-called direct-to-consumer (DTC) genetic tests can provide information ranging from a ... [More]
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