The FDA considers the company’s service a “medical device” and therefor needs regulatory clearance. Risk assessments and safety is the grounds for the FDA letter. Cancer tests are the big concern with saliva testing.
False positive results is where the FDA is looking as they state a patient could undergo screenings and surgeries that are not in fact necessary. In addition false negatives are also addressed by the FDA stating that a patient would not undergo appropriate testing and diseases could be missed. It sounds like it’s a 501k time application perhaps to establish clinical boundaries and values. There has been ongoing meeting between the FDA and the company.
Update: If you have not read this article, do it…see how data selling makes big riches for Google and others as well, Scientific American article from Professor Siefe, mathematician at NYU gives his take and it’s a good one..full story at the link and a couple preview paragraphs below…
“But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.
What the search engine is to Google, the Personal Genome Service is to 23andMe. The company is not exactly hiding its ambitions. “The long game here is not to make money selling kits, although the kits are essential to get the base level data,” Patrick Chung, a 23andMe board member, told FastCompany last month. “Once you have the data, [the company] does actually become the Google of personalized health care.”
While the FDA concentrates on the question of whether 23andMe’s kit is a safe and effective medical device, it is failing to address the real issue: what 23andMe should be allowed to do with the data it collects. For 23andMe’s Personal Genome Service is much more than a medical device; it is a one-way portal into a world where corporations have access to the innermost contents of your cells and where insurers and pharmaceutical firms and marketers might know more about your body than you know yourself. And as 23andMe warns on its website, “Genetic Information that you share with others could be used against your interests. You should be careful about sharing your Genetic Information with others.”
Also scroll down to the footer to watch “Context is Everything” from Professor Siefe or visit the Algo Duping page for even more videos on how all of this takes place and the huge profits made from data selling. This is what I think could be done and my campaign to license (start an index) on all the data sellers out there as it’s really totally out of control. FTC thus far as well as Congress have been pretty useless and have not shown any teeth. BD
23andMe, which was founded in 2006 by Anne Wojcicki with the backing of Google, sells DNA testing services that the company says detect a range of genetic mutations and provide information about a person's health risks. Wojcicki recently separated from her husband, Sergey Brin, a co-founder of Google.
In a warning letter dated November 22 and released on Monday, the FDA said it considers the company's product a medical device that therefore requires regulatory clearance, "as FDA has explained to you on numerous occasions."
The agency said that if the company's risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.
I guess it’s time to keep up with the other “big drug store chain” as a couple years ago Walgreens made a business swap to secure the Omni-Care infusion business. Nobody really pays a lot of attention to this business until something happens and that did occur with a security breach with Walgreen’s infusion subsidiary Crescent not too long ago.
Coram has a network of 85 infusion sites as shown on their website.
The website has a patient education area to where you can watch videos on how to care for your catheter. how to flush it and trouble shooting your venous access device. I mention this as it gives an idea of what they do at Coram. BD
Coram provides infusion therapies for the treatment of acute and chronic ailments like immune deficiencies, rheumatoid arthritis, multiple sclerosis and nutritional deficiencies to more than 20,000 patients each month, primarily at their homes. It also has a network of more than 85 infusion sites.
The video is a family below who witnessed the rampage as they were there taking their daughter in for surgery. The poor nurse just came around the corner to see what was happening and that’s when she was stabbed. It was not a a gun this time, he did all his damage with a knife.
The nurse who was killed 57 years old and had worked at the hospital for many years. The actual scene took place in the ambulatory surgical center and one survivor remains in critical condition. The man with the knife was the son of a patient at the center. From the video they stated there was a lot of pushing and shoving going on before all realized he was going around stabbing people. Police handcuffed and had him in custody quickly upon their arrival. BD
Police responded to the scene within minutes after receiving calls about stabbings occurring in the surgery center, and though the suspect fled the scene of the stabbings, they were able to apprehend him just blocks away within a very short time.
The suspect, identified as Kyron Rayshaun Templeton, 22, of Longview, fled but was taken into custody a short while later on Sixth Street in Longview. There was a scuffle during his arrest, but no officers were injured. He is now charged with murder and four counts of aggravated assault. He is being held on $2.6 million bond.
One East Texas family arrived at Good Shepherd around 5:30 Tuesday morning because their six-year-old daughter was scheduled for surgery. They say everything was running smoothly until about 7 a.m., when they witnessed a young man, now identified as Templeton, stab two people just feet away from where they were standing.
This is pretty good and makes some good points for when the Healthcare.Gov site is working for you. He waits long enough and the information comes up and this was done a few weeks ago so keep that in mind. He goes through applying with a health insurance site to compare. There’s a lot of questions versus the exchange site. He’s reading all of it too four our benefit.
At any rate you get the picture and if you have applied via a commercial insurance site then you know what all the questions are about. So this makes the exchange sites look pretty good as far as what information you need to provide. BD
Even with all the glitches, it's apparently still faster to apply for health coverage with the new exchanges under the Affordable Care Act than going through the invasive application process with an individual private care insurer that existed before the act went into affect.