Subscribe to the BioNews newsletter for free

Advanced Search

Search for

Like the Progress Educational Trust on Facebook



FDA questions five US companies about unapproved genetic testing

28 June 2010

By Seil Collins

Appeared in BioNews 564

The Food and Drug Administration (FDA) has told five US companies that the genetic tests they sell directly to consumers are unapproved.

In a letter to one of the personal genetics companies, Alberto Gutierrez, in charge of diagnostic test regulation at the FDA, said that because the genetic tests are 'intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease', or are 'intended to affect the structure or function of the body', they are considered medical devices.

Medical devices are required to receive regulatory approval before they can be marketed. Gutierrez writes that pre-market review allows for an independent assessment of the test's ability to generate reliable results, upon which consumers can base good healthcare decisions.

The decision of the FDA to only now question the regulation of these devices has emerged as companies have modified their claims - from determining paternity or ancestry, to claims that are more medical and higher risk. Gutierrez told USA Today that the ones they're worried about 'are those that say something about drug metabolism or those that define risks for major diseases'. He specified, 'definitely all the cancer ones are ones that we think are high-risk'.

In response, 23andMe issued a statement disagreeing with the FDA, saying they believed their consumers had the right to access as much information about their genes and bodies as they choose, but also stated they were open to discussions on ways to regulate the personal genetics industry.

Gutierrez stated that they did not want to deny people information, but simply make sure people were given correct information.

Daniel Vohause, an independent lawyer specialising in genetic testing regulation, told The New York Times that no-one had a clear understanding of where the FDA were drawing the line at this point - the FDA has not removed the test from the market, simply initiated investigation as to an appropriate regulatory framework for approval. Vohause said the FDA was 'trying to keep up with a commercial space that is moving way faster than they are capable of'.

NY Times | 11 June 2010
USA Today | 15 June 2010


06 June 2011 - by Rosemary Paxman 
Direct-to-consumer (DTC) genetic tests provide an inaccurate prediction of disease risk and offer little benefit to consumers, scientists claim...
17 January 2011 - by Rosie Beauchamp 
A recent study suggests American consumers would be prepared to pay on average up to $600 for a predictive genetic test where no direct treatment is available....
26 July 2010 - by Chris Chatterton 
Direct-to-consumer genetic tests were called into question by the US authorities last week. An undercover investigation by the US Government Accountability Office (GAO) found that test results were often inaccurate and misleading....
12 July 2010 - by Nishat Hyder 
Proposals to genetically test incoming freshman and transfer students to the University of California, Berkeley (UCB), are under fire. UCB intended to offer a genetic test to its thousands of entrants, which would test three variants: genes that affect the ability to absorb folic acid, metabolise alcohol and digest lactose....

05 June 2010 - by Dr Megan Allyse 
The University of California at Berkeley has recently received a great deal of attention for its revised curriculum for incoming first years which will offer students the opportunity to have a DNA sample analyzed for genetic variants...
17 May 2010 - by Rosemary Paxman 
Personal genetic testing kits are to be sold in US pharmacies for the first time, US biotech firm Pathway Genomics has announced...
04 May 2010 - by Dr Sophie Pryor 
Whole genome analysis has been used for the first time to gather clinically-useful information about the risk of developing diseases later in life. Stephen Quake, an apparently healthy, middle-aged professor of bioengineering at Stanford University in California, volunteered to have his entire genetic code screened. He was found to be at increased risk of developing diabetes, some cancers and of having a heart attack...

Be the first to have your say.

You need to or  to add comments.

By posting a comment you agree to abide by the BioNews terms and conditions

- click here to enquire about using this story.

Published by the Progress Educational Trust


Public Conference
8 December 2017

Speakers include

Professor Azim Surani

Professor Magdalena Zernicka-Goetz

Professor Robin Lovell-Badge

Sally Cheshire

Professor Guido Pennings

Katherine Littler

Professor Allan Pacey

Dr Sue Avery

Professor Richard Anderson

Dr Elizabeth Garner

Dr Andy Greenfield

Dr Anna Smajdor

Dr Henry Malter

Vivienne Parry

Dr Helen O'Neill

Dr César Palacios-González

Philippa Taylor

Fiona Fox

Sarah Norcross

Sandy Starr


Good Fundraising Code

Become a Friend of PET HERE and give the Progress Educational Trust a regular donation