[Rooters] The company, DNA4Life, believed it did not need FDA approval before selling the test.
CHICAGO (Reuters) - The U.S. Food and Drug Administration sent a letter to privately held gene testing company DNA4Life over the company's sale of an unapproved direct-to-consumer gene test to predict drug response.
In its letter, posted on Monday, the agency said it was unable to identify any FDA clearance for the company's test. The letter follows 23andMe's limited relaunch last month of a series of direct-to-consumer (DTC) tests after the agency ordered the tests off the market.
DNA4Life told Reuters in an earlier interview that it did not believe it needed FDA approval to sell its test.
DNA4Life, based in Mandeville, Louisiana did not immediately respond to requests for comment.
In its letter, the FDA said the company's test appears to meet the definition of a medical device, which requires marketing approval. The agency said the company needs to provide evidence that the device has been approved or information regarding why it believes the test does not require FDA approval.
In a statement sent to Reuters last week, FDA spokesman Eric Pahon said the FDA believes that "certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks."
The letter comes in the wake of 23andMe's two-year tussle with the FDA over its direct-to-consumer personal DNA testing service, which the FDA ordered off the market in 2013.
Last month, 23andMe relaunched its service with a limited number of genetic tests for carrier screening - tests that show whether an individual carries genes associated with 36 different disorders that could be passed on to a child. Genetic link analysis? Potential generational impacts from behavior, lifestyle choices and drugs? Who knew?
23andMe still does not have FDA approval to resume the sale of tests that predict drug response.
Experts in pharmacogenetics believe those tests could be much riskier in the hands of consumers, who might use the information to make decisions about the drugs they are taking.
The U.S. Gov't Genetic Information Nondiscrimination Act will save us. The people must never discover that the earth is not flat or that some within a particular species are actually different from others within that species, or that Pharmacogenetics is actually their friend. Costs must be shared, it's only fair.
#3
I would say it is more of a tool that used medical knowledge and databases to bring about a result.
IMHO, the FDA doesn't really have much of a say since the person isn't brining the product into their body or using it as a medical device like an EKG.
If fitbit watches aren't FDA approved, then this shouldn't be either.
#4
I will repeat. Once partners and myself considered a 3d device to track changes in body imperfections like moles. I did a search on other devices and came across one that looked for cancer in moles with several colors of low powered LEDs. (Yes low power versions of LED lighting that is all about us starting with calculators.) The crooks at the FDA demanded a 230 million dollar study from that company to prove that low power colored LEDs wouldn't cause cancer. The doctors who invented the device wanted to use it so bad they caved and let VC's get more than a %90 interest so that the stupid study could be paid for.
We decided to never ever do anything that could be construed in any way as a medical device.
My opinion of those FDA bureaucrats is below my respect of Satan and his fallen.
They are even below pond scum.
#8
Snowy - the old crushed crocus med for gout?
BTW... crush a crocus and put the juice on the apical meristem of a monopolid plant and the cells that develop from that meristem become di-and-multi-polid. (multiplies chromosome numbers) You can then cross it with other species that match the new chromosome count or just have a custom plant that might optimize some feature for you.
#12
My testosterone patches are a "Medical Device".
Posted by: Deacon Blues ||
11/10/2015 19:38 Comments ||
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#13
My testosterone patches are a "Medical Device".
The nutraceutical DHEA is a testosterone precurser that the body converts to testosterone, Deacon Blues. Available in the vitamin section of your grocery store or drug store between fish oil and vitamin D, without any interference from the FDA. Also useful for women taking hormonal birth control or hormone replacement treatments, as both significantly reduce normal female levels of testosterone.
A long time ago we used to watch this lady as she languished in house arrest at the pleasure of Burma's military junta. Now her party might well form the country's next government, though she will not.
[AnNahar] Supporters of Aung San Suu Kyi's pro-democracy party on Monday cheered early results from Myanmar's historic election, with hopes boosted of sweeping gains to carry it to power after decades of military dominance.
Election authorities have so far announced only a small fraction of the results, but the National League for Democracy has scooped the lion's share of those, boosting enthusiasm in the crowds in front of Suu Kyi's party headquarters in Yangon Monday evening.
"We'll win tonight, we'll stay until we win anyway," said 24-year-old Wanna Htay, sporting a scarlet bandana with the party's iconic fighting peacock motif as the crowd sung and cheered around him at the height of the celebrations.
Continued on Page 49
[Daily Caller] Students at the University of Missouri formed a "no media safe space" to prevent reporters from interviewing protesters on Monday after the school's president announced his resignation in response to activist demands. Call us when yer ready for that interview. We'll just sit back here where it's safe and finish these fried baloney sammiches.
A group calling themselves Concerned Students 1950 had demanded that school president Tim Wolfe apologize, admit to white privilege, and resign because of his alleged failure to address a series of racially-tinged incidents at the school.
The school's student body president wrote in a recent Facebook post that he was the target of racial epithets from fellow students. A graduate student named Jonathan Butler also embarked on a hunger strike after he says Wolfe failed to act after a swastika was found scrawled in feces on campus.
Butler's strike prompted some members of the school's mediocre football team to boycott future football games.
#2
I look forward to the gang of 'old and privileged' MSNBC media marched before the cameras for "self criticism" by this new Red Guard. Just think of yourselves as Trunks in one of your rigged 'debates'.
#5
Problem is one or more of these snowflakes will be hired by your company's HR department in order to promote 'diversity in the workplace'.
And then we will need to apologize profusely for our 'white privileges' and have incompetent boobs promoted over us who don't have a clue what they are doing but, hey, they have the right skin color...
Political Correctness is already poisoning our workplace.
#6
CF, those snowflakes might very well get hired by a lot of modern HR departments - which are largely staffed with like-minded social justice warriors. But they probably aren't interested in going to work for companies - they'll be following the path to power taken by our Community Organizer in Chief, and for that, such protests are a golden credential.
#12
And their families. "Participant" Ribbons for everyone!
Posted by: Frank G ||
11/10/2015 13:33 Comments ||
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#13
I recently had a young, female delicate snowflake chide me on not apologizing for my male privelage. I said, "So you were drafted right out of high school, given 8 weeks of training, and sent to Viet Nam?". Of course she said no and she wasn't even born then. I told her what she could do with he "male privledge".
Posted by: Deacon Blues ||
11/10/2015 19:36 Comments ||
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#14
Good for you, Deacon Blues. And salutary for her.
[Pointer View] West Point's Inaugural Gay Rights History Luncheon took place Oct. 30 at the West Point Club Grand Ballroom. The event, which was hosted by the Cadet Respect Committee, filled its roster after just five days of it being announced.
Class of 2016 Cadet Zoe Kreitenberg came up with the idea of the luncheon because no such event existed.
"We have lots of events here for different communities," said Kreitenberg, the Brigade Respect Executive Officer. "We thought that it was unfair that we didn't have one for the LGBTQ community, which is definitely growing in its importance in American history, especially in my generation's lifetime."
Kreitenberg emphasized that the purpose of the luncheon was to educate the Corps and help them become excellent leaders.
In order to best educate her peers, Kreitenberg felt that there was no better way than to invite living history to speak at the luncheon.
She reached out to Brig. Gen. Randy S. Taylor, the Director of Architecture, Operations, Networks and Space for the Army Chief Information Officer/G-6.
"We're really lucky to have him," Kreitenberg said. "His experience relates to the overall history of the Gay Rights Movement in America and in the Army."
Posted by: Redneck Jim ||
11/10/2015 5:22 Comments ||
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#4
Silly rabbit, you still think this is a republic/democracy, government in the interest of the majority? It's been a oligarchy for over a generation where minorities dictate what the life of the majority will be, with or without their consent.
Prudence, indeed, will dictate that Governments long established should not be changed for light and transient causes; and accordingly all experience hath shewn, that mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed.
Posted by: Ricky bin Ricardo (Abu Babaloo) ||
11/10/2015 11:22 Comments ||
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#7
Throw out your hands!!
Stick out your tush!!
Hands on your hips
Give them a push!!
You'll be surprised
You're doing the Cadet Mistake!!
OORAH!!
Come on, try it; move the scene along
Fifty bazzilion A-rabs can't be wrong
Wheeeeeeee!!
Throw out your hands!!
Stick out your tush!!
Hands on your hips
Give them a push!!
You'll be surprised
You're doing the Cadet Mistake!!
..................OORAH!!
#8
Only intermittent two part harmony, and simple harmonies at that? They aren't demanding much of themselves, though at least they're enunciating properly. One hopes some of their other pieces are a good deal less precious, and a great deal less redolent of junior high chorus.
Anything in common with the troubled VA Directors Diana Rubens (Philadelphia) and Kimberly Graves (St. Paul, Minn.), and some of Champs other appointees? Yes, as matter of fact.
A multi-volume chronology and reference guide set detailing three years of the Mexican Drug War between 2010 and 2012.
Rantburg.com and borderlandbeat.com correspondent and author Chris Covert presents his first non-fiction work detailing
the drug and gang related violence in Mexico.
Chris gives us Mexican press dispatches of drug and gang war violence
over three years, presented in a multi volume set intended to chronicle the death, violence and mayhem which has
dominated Mexico for six years.
Rantburg was assembled from recycled algorithms in the United States of America. No
trees were destroyed in the production of this weblog. We did hurt some, though. Sorry.
