By Sandra M. Jones and
Bruce Japsen | Genetic testing is making its way to the corner drug store, and federal
regulators aren’t too happy about it.
Walgreens will begin
selling personal genetic testing kits on Friday, the first major retail
chain in the U.S. to offer the home tests. CVS plans to have the same test kits in its stores
by August.
Both drug store chains are buying the kits from
Pathway Genomics, a San Diego-based startup that offers genetic health
and ancestry reports.
The over-the-counter tests, which have been available through a few
Internet retailers, haven’t reached a mass audience until now. And their
pending arrival has scientists and bio-ethicists concerned that
consumers will misuse or misunderstand the results.
The U.S. Food and Drug Administration told the Tribune Tuesday that it is investigating the medical claims two-year-old Pathway is making in marketing its genetic test to consumers. The test has not been approved by U.S. regulators.
“We are in the process of investigating this test,” said Alberto Gutierrez, the office director for the FDA’s office of in-vitro diagnostics. “We weren’t aware of this test previously.”
Pathway officials assert that the company’s home genetic test meets federal regulations and doesn’t require FDA approval.
“We do believe we are in compliance with all FDA guidelines,” said Ed MacBean, vice president of product development of the two-year-old start up. “If the FDA contacts us, we will discuss it and address any concerns they might have.”
The Pathway Genomics test kits, sold under the brand name Insight, pledge to provide information on the risks of getting certain diseases, such as Alzheimer’s or breast cancer. The tests also look at the likelihood of passing health problems on to children, and examine how individuals may react to certain drugs.
But the kits are controversial. Some scientists caution that home tests can’t provide meaningful information. There is no concrete test for Alzheimer’s, for example, because researchers still aren’t sure what causes the disease.
The National Society of Genetic Counselors issued a statement Tuesday warning that even though selling home kits at drug stores would give more people access to genetic testing, receiving genetic information directly from a manufacturer without input from a doctor “increases the chance for misunderstanding or misinterpretation of results.”
Drug stores already carry DNA paternity tests and gender prediction tests for the home, but genetic tests have been harder to find. They typically require a visit to the doctor’s office. Pathway, which has been selling the tests online for the past year, is hoping that appearing on store shelves will help it reach more consumers than Internet rivals 23andMe, Decode Genetics and Navigenics.
The potential market for home tests is huge, given how eager many people are to predict their future health. But some fear that the massive amount of data coming out of the Human Genome Project could be abused.
“These companies are marketing tests to people and promising things which they aren’t fully explaining to the consumer,” said Darrel Waggoner, associate professor of human genetics and pediatrics at University of Chicago Medical Center. “They are saying they can test for diabetes, hypertension and heart attack. That sounds very attractive to the uneducated consumer.”
The Insight genetic test kit, priced at $20 to $30, comes with a vial and a shipping envelope. Buyers send a sample of their saliva to a Pathway Genomics laboratory, and receive their results online. The online account needed to view the reports varies from $79 to $179, depending on the type of test requested.
Pathway screens for genetic markers of more than 70 diseases. It also recommends buyers discuss results with a doctor or one of Pathway’s own genetic counselors, particularly for complex health issues such as heart disease and cancer that have multiple causes including lifestyle and environmental factors, said Pathway’s MacBean.
The truth is, for most diseases, no one knows exactly why one person gets it and another does not, said Peter Kraft, Deputy Director of the Program in Molecular and Genetic Epidemiology at Harvard School of Public Health.
“The company states, everyone has the right to know the secrets hidden within their DNA,” he said. “Fair enough, but that is a lot of work! I don’t think this is the way to go.”
In a paper published in The Lancet in April, it took a team of more than 30 researchers to analyze results from full-genome testing of a 40-year-old man with a family history of coronary artery disease and sudden death. While the amount of data they analyzed was far greater than that of Pathway’s kit, the researchers used much of the same data on genetic health risks, disease risk and drug information.
“To my mind, it was a great illustration of all the gaps we have,” Kraft said.
Still, over time as technology improves, proponents predict that home genetic tests could become as common as pregnancy tests, helping consumers get initial information before going to the doctor.
“We recognize that for some people, genetic responses are becoming a more important component of managing their health care,” said Jim Cohn, a Walgreens spokesman. “There are people who want to know more about their genetic makeup, and we pride ourselves on being convenient and accessible.”
Trine Tsouderos contributed to this report.
isn’t society already paranoid enough – my goodness we have enough idiots in illinois who would have their children killed for shoplifting
No longer will we have to rely on Maury for paternity tests
Will the test show if a person is totally stupid?
Sounds like a back-room handshake deal to sell Pathway Genomic laboratory services. Is Walgreens getting a cut of that $79 to $179 additional online fee??
“Sounds like a back-room handshake deal to sell Pathway Genomic laboratory services. Is Walgreens getting a cut of that $79 to $179 additional online fee??”
This isn’t even “back-room”, it takes about 10 seconds to realize what is going on here. It’s not bad business, this type of partnership happens in all sectors of business there is nothing wrong with it.
I don’t see what is so wrong with this, if people really want to know this type of **** who is to stop them from buying it. If you call them “stupid” then this is good for you because it’s taking money out of their “stupid” wallets.
Distributing genetic testing through pharmacies will expose more people to its availability. However, people should first meet with a genetic counselor to determine whether genetic testing is right for them and to prepare for what they might learn. Consumers can find a genetic counselor using the Find-a-Counselor link on http://www.nsgc.org.The NSGC recommends asking the following questions before having genetic testing: 1. What will the test tell me? Discuss with your genetic counselor what you would like to learn from genetic testing. There are many different types of genetic tests. If the wrong test is ordered, it may not give you information about your medical concerns.2. What is the scientific basis for the testing? Some genetic tests provide more conclusive results than others. Also, a genetic counselor can integrate the test results with your medical and family history to provide more powerful and useful information.3. What might you do with the information once you know the results? Consider the implications of knowing the test results and the impact that could have on you and your family, both medically, emotionally and in terms of life planning. 4. Will there be a knowledgeable health care professional involved with giving you the test results? It is important that someone who has expertise in genetics helps you understand and interpret your test results. For example, genetic counselors have specialized training in medical genetics and counseling and have Master’s degrees in their field. Elizabeth Kearney, President, National Society of Genetic Counselors
Hope its more accurate than those doggie DNA kits they use to determine the breed of your mutt. I did one on a whim and told my vet the results, and she said there was no way based on the elongation of his body type that he would be what they said he was.
I could not agree more with Ms Kearney. As a spouse who’s wife died with Huntington’s Disease, I can’t imagine my adult children walking into a drug store, buying the kit, sending their sample off and getting the results of whether or not they carry the mutated HD gene over the internet instead of getting the results from a knowledgible neurologist. And to not have anyone with them when they received those results, whether positive OR negative, just scares the hell out of me. Those receiving a positive result to the HD gene have a higher than normal suicide rate.
To me, this is totally irresponsible on both the manufacturer as well as Walgreen’s. Without a trained professional meeting with the individual in a face to face setting is just wrong.
This is great news! Then we can isolate the gene that is responsible for homosexuality–and eradicate the natural propensity to engage in it, thereby improving society.
Then we can isolate and type the gene that causes pedophelia and liberalism, then we’re set.
Hmmm…so basically, you can administer this test upon yourself and then surrender the results to a private corporation. Just another step toward people selling themselves into corporate wage slavery on the installment plan.
These corporations cannot be trusted to manage individuals’ financial information, basic privacy rights or even their own businesses correctly, and there are people out there dumb enough to entrust these private corporations with their genetic information?
Man…this just goes to show, the corporations wrap something in a shiny enough package, and they can get idiots to chomp at the bit selling themselves out little by little.
I have to figure out a way to rip off and undermine stupid people under the guise that I’m “helping them.” Clearly, there are a lot of self-disrespecting people out there who are fodder for exploitation.
mAL: You clearly don’t know enough about socialization to comment on improving society. Please stay away from topics beyond your simple comprehension. You’re just another “conservative” using that as an excuse to profess their fascist and anti-American views. Fortunately, we have a constitution to protect us against people like you.
The FDA does not have a very good record of protecting consumers. The fact that they do or do not approve something does not influence me at all. I am betting they are looking for some $$$$$$$$ from either Walgreens or Pathway.
keep trying to make society douch fresh and changing genes and i will kill all who are responsible
Ok so you have to pay for the $79-$179 to get the test results…so what you are paying for in the store is $20-$30 for a test tube to spit in…that’s a pretty good mark-up!!
It’d be a lot cheaper if they just had the kid at the photo counter run the test – and the results would probably be about as useful.
Maybe he could guess your weight, too.
It’s just information, and like any information it is what you make of it. It’s not as though they’re marketing a substance that gets injected, ingested, or inhaled, for petesake.
Some people rely on information from astrologers to determine which holistic medicines to use. Why doesn’t the FDA start regulating astrologers, too? Sheesh!
The FDA didn’t approve it? LOL! That’s laughable. Like the FDA has been interested in protecting the consumer in recent decades. The list of diet pills, and pharmaceuticals that have either killed or seriously debilitated people over the years is astounding. The FDA wasn’t interested in doing a single thing until it became national headlines. The worst thing that could happen from a genetic testing kit is someone goes to a doctor and gets confirmation.
All I can say is that if this kit was Made in China, Walmart would be all over it.
DYI (do it yourself) is so in. Now we have DYI medicine. When will people learn that there is a reason why people go and get trained for certain professions?
Even if it does give good results will the average person really understand what the test is telling them? Will the test tell them what to do in order to prevent certain diseases? Wouldn’t it be just as effective (or more so) to live healthy than take the test?
Please, listen to the NSGC, if you do this yourself and don’t get go see a doctor, they’ll lose money and members. Travesty!
This seems like s sleazy move- to sell such a product. Walgreens is a pharmacy, They tout themselves as “healthcare provider” and “theres a way to stay healthy”.. They should not be selling this crap.
The idea that you can gain such important knowledge through a test that hasn’t even been heard of by the FDA- Just how accurate is this test?(The comment above about the dog DNA test was perfect) The idea that people can forgo talking to a genetic counselor, or doctor about this information- it just seems that a pharmacy might have a little more concerned with the gravity of the information, reliability and wellbeing of its customers? Walgreens seems to be mainly concerned with its profit margin.
hehe o . k . so here’s exactly how dumb I am, halfway through reading your post I dropped my computer mouse and shut the firefox in error and I could not find your webpage again until 6 days later to finish reading through from the spot i had left off mainly because I didn’t remember how I linked to your site to begin with haha anyway it was worth the hold out..kudos