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This is very unwarranted. Consumers should be smart enough to know that this genetic service is merely for education and not for diagnostics.
Quote:
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
In a warning letter posted online Monday, FDA regulators say that the Silicon Valley has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.
23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.
The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a new field of startups selling personal genetic information. The spread of consumer-marketed DNA tests has troubled doctors and health officials who worry that the products are built on flimsy science.
For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.
A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes it has been late responding to FDA questions about the application.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," said Kendra Cassillo in a statement.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter.
The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.
The FDA gives the company 15 days to respond in writing to the letter's concerns. Warning letters are not legally binding, but the government can take companies to court if they are ignored.
23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.
Company executives previously said that they first contacted the FDA in 2007, before launching their product. The agency did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
The FDA already regulates a variety of genetic tests administered by health care providers. The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.
Consumers order the company's $99 product online. Once the kit arrives by mail they are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis. 23andMe says the customer's DNA is analyzed to determine their likelihood of developing various diseases and responding to various drugs. The test also claims to provide information about ancestral background, though this information is not regulated by the FDA.
My daily horoscope can't be proven to be scientifically accurate either. I know people who have sought medical care or other similar actions based upon what some fortune teller has told them.
Many years ago I sold cars. I sold a really nice used car to a lady and at some point later I see her in the service waiting area and asked her if there was something wrong with her car. She assured me that there wasn't but a fortune teller had told her that she would soon have car problems so she brought it in for an inspection. No problems found.
Now was all of this necessary? No, but it put her mind at ease. As far as I can determine, no harm done. Yes the fortune teller was a quack only out to take her money but she believed in it.
I don't know.....I see this as nothing more than a verification of the old saying "a fool and his money is soon parted". The government can't save people from themselves.
I agree. I'm a member of 23andme, and the worse side effects that could happen are hypochondria and/or an impending sense of doom. Its very educational for the customers and a great research opportunity for the company.
Of all the things the FDA could be regulating, maybe they could be focusing more on salmonella filled chicken.
23andme is a great test. I've taken it, my grandmother took it, and my best friend took it. I hope this dispute is settled so they can go back to filling their database with more people.
My health results weren't surprising to me.
I did learn that I carry one copy of the gene that causes hemochromatosis. I am very happy to know this in case I have kids in the future I will know this is a risk.
I could see how damaging the test could be though for someone with hypochondria (something the 23andme test doesn't look for. Lol). Imagine if your results said you would likely develop Alzheimer's? The next time you forget where your car keys were you might go straight to a neuro doctor for evaluation. Lol.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter.
Let me get this straight.
This company is being shut down because it has not proven that its product does what it claims.
But Obamacare, which has been exposed as definitely NOT doing what it claims (saving us money, letting us keep our health plan or doctor, giving us "better" insurance, etc.).... is not only being allowed to keep making those claims, but we are FORCED to participate in it, or else pay stiff penalties if we don't???
Basically, as government is wont to do... It bans everything it doesn't allow.
We must be 'saved' from those things it doesn't give its blessings to.
Just one more tiny example of the vast amount of harm that has befallen us due to liberals insisting that government ban everything they don't want people to do.
I think the complication with this issue is is regards solely to the health risks that 23andMe reports on. So looking at my results right now, 23andMe is telling me that they think I have a 5% chance of chronic kidney disease and the national average is only 3.4%. So the FDA doesn't like it if I go to a urinary doctor and get diagnosed with kidney stones and then me saying "oh yeah, my DNA said I am at risk for stuff that that."?
As for this. What a crock of bogus. If you test positive for this gene then I suggest you get at least a second test to confirm before you hack off your boobs!
"23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery."
Now, I did fill out a survey from 23andMe earlier last week. It does seem like they are wanting to get into the business of offering medical kits for specific illnesses (in this case, it was blood pressure). If it wants to start doing this then it will need to undergo FDA approval. No taking short cuts.
I think the complication with this issue is is regards solely to the health risks that 23andMe reports on. So looking at my results right now, 23andMe is telling me that they think I have a 5% chance of chronic kidney disease and the national average is only 3.4%.
ha! i have them beat, i dont have to take their test, as i have a 100% chance of chronic kidney disease.
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