Walgreen's is ready to plunge headlong into the brave new world of personal genomics retailing, becoming the first retailer to stock store shelves with genetic-testing kits that can test for a person's likelihood of developing a range of genetic ailments, from Alzheimers to breast cancer to obesity. The FDA, however, isn't so thrilled.
The tests, which retail for $20 to $30, allow customers to collect their own saliva sample in a vial and send it to the test's maker, Pathway Genomics of San Diego. For an additional cost -- ranging from $79 for drug-response results to $249 for a suite of "pre-pregnancy planning results and health condition analysis -- Pathway will analyze the customers' genetic code, scanning for markers associated with certain diseases.
Tests like Pathways aren't new. They've been sold previously online, generally for use by doctors and clinical professionals in the lab. But the FDA is concerned with the direct-to-patient marketing of genome tests because they bypass certified medical personnel, and the agency fears patients will take decisions like drug dosage into their own hands.
That, and the agency is not convinced the test results are completely accurate.
The FDA may take action against Pathway and other makers of genetic tests, perhaps even pulling the tests off the shelves. Walgreen's says it's just supplying a demand among consumers to know more about their own health and predisposition toward certain illnesses, which is a fair defense all things considered. The FDA seems to feel its less a matter of free commerce and more a matter of diagnostic medicine.
It will be interesting to see how this one shakes out, as it's the first real pushback from the FDA regarding retail personal genomics. Walgreen's plans to retail the tests directly to consumers at 6,000 of its 7,500 stores if the FDA doesn't bar it from doing so. This could kick off quite a public debate about the value and accuracy of personal genetic testing and whether its role is personal or, like that of prescription drugs, one that must be shared with your doctor. Feel free to weigh in below.
Can we not block spam like the above comment?
Lord no! Then we'd be too technologically advanced! Or possibly rude. One of the two.
walgreens isn't the first to offer these - though they may be the first to offer the tests that look for genetic diseases. you can readily get similar products that test bone and heart health, etc within the body.
This is outside the scope of the FDA's authority. In the strict sense, this doesn't treat or diagnose any disease. It gives probabilities for future health problems, but doesn't diagnose anything you now have.
Does the FDA claim authority over fortune tellers too?
The seeker of knowledge who seeks to reach beyond the stars to go where no mans gone before to see things no man has seen and bring these experiences back for the whole world to hear and see.
The way i see this is the health care system is going to dog it say alot of negative stuff just becouse if this becomes big then think instead of going to your doctor for certain concerns from which they would give you a large number of tests when you only need one then tell you your fine unless then you have a a shady doctors and he wants some extra money and he perscribes you medicine that you dont needsaying your sick when your not .i see this as a great step forward i hate going to the doctors sitting in a waiting room for a doctor around a bunch of sick people coughing spitting while talking and trying to talk to you the person siiting next to you may have some skin desease that eats your face off you get me i hate going to doctor if i can test myself ill pay whatever it costs.i think the fda is going to cut it out not becouse their scared of people self medicating themselves becouse you cant you still need a doctors srquest to get drugs at pharmacys i believe they see the signifigant loss in money for the health care industry couse i bet to trest for these things the ones people fear most the health care system gets bank.That's my thots any how have a good day yes im talking to you the one reading this you have a good day and remember anyone can be great
When it comes to saving Lives, money shouldn't even be an issue. Everything should be free. The way this world is run, is pure crapola. Wake me up when we have a Star Trek Federation.
Will it detect the genetic markers indicating why I am so much smarter, so much more handsome and an exponentially stronger babe-magnet than all of you?
Regarding the spam, it's inexcusable for PopSci not to have an abuse reporting link on each post, like other Websites have. Complain to webmaster at Popsci dot com and cc to letters at Popsci.
Sounds to me like they're more concerned with protecting doctors' monopoly than protecting the public. The FDA is butting in where they have no business.
It's rediculous, that after all those years of schooling, the long hours, the sheer intellectual ability and thousands of hours of studying required to become a doctor, they require a high salary! As proven by the total lack of prescription drug abuse, and the near perfect results of self-diagnosis of just about every disease, doctors are an antiquated social fixture. They are lazy, stupid, but above all they are selfish. Every dollar we can keep away from their coniving, greedy hands, we can give to the CEO's, the lawyers, the BP execs, anyone deserving of that money. Ugh, and don't even get me STARTED on those overpaid inner-city teachers.