“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”—
FDA warning letter to 23andMe tells company to immediately stop marketing its Personal Genome Service. A very blunt letter. Very. (via scotthensley)
"It has been a mystery since 1966 when, three years after the president’s assassination, it was discovered that his brain, which had been removed during the autopsy and stored in the National Archives, had gone missing. Conspiracy theorists have long suggested the missing organ would have proved…
“You don’t know anyone at the party, so you don’t want to go. You don’t like cottage cheese, so you haven’t eaten it in years. This is your choice, of course, but don’t kid yourself: it’s also the flinch.
Your personality is not set in stone. You may think a morning coffee is the most enjoyable thing in the world, but it’s really just a habit. Thirty days without it, and you would be fine. You think you have a soul mate, but in fact you could have had any number of spouses. You would have evolved differently, but been just as happy.
You can change what you want about yourself at any time. You see yourself as someone who can’t write or play an instrument, who gives in to temptation or makes bad decisions, but that’s really not you. It’s not ingrained. It’s not your personality. You personality is something else, something deeper than just preferences, and these details on the surface, you can change anytime you like.
If it is useful to do so, you must abandon your identity and start again. Sometimes, it’s the only way.
Set fire to your old self. It’s not needed here. It’s too busy shopping, gossiping about others, and watching days go by and asking why you haven’t gotten as far as you’d like. This old self will die and be forgotten by all but family, and replaced by someone who makes a difference.
Your new self is not like that. Your new self is the Great Chicago Fire—overwhelming, overpowering, and destroying everything that isn’t necessary.
“I’ll tell you something really terrible: every relationship I’ve ever had with a woman, at some point very early on, I’d bring them to Yasuda in New York, and I would watch how they would eat. If they talked too much, didn’t understand how to eat sushi, if they did not eat the uni - we will never have a relationship. That’s it. It’s the end.”—Bourdain in Japan, confiding to his mentor, Naomichi Yasuda (via kateoplis)