Scientists are redesigning bacteria like these to “speak” a new language.

All living things pretty much use the same language to read their genes. That is about to change.

Scientists in Boston are close to teaching a strain of bacteria a new dialect of the genetic code. In combination with some work done by a different group in 2010, we are now getting to the point where we can actually think about (re)designing life. Which is a big step from what we have been able to do up until now.

The genetic engineering we have done in the past has been pretty crude. We have mostly added pre-existing genes to cells to give the cells new properties or to have the cells make something for us.

So we add a human gene to bacteria so they will make insulin for us. Or we add a gene from bacteria to a plant to make the plant resistant to an herbicide like Round Up. Or we even add two genes to cause rice to make vitamin A like in golden rice.

Now we aren’t always this unsophisticated. We have managed to do some pretty elegant things with genes in mice. There we have tinkered with mouse genes to slightly change how they work or to control how they are expressed.

But these new experiments are different. This is changing the language of life so we can make a living thing do things nothing living has yet been able to do. Maybe this is even the start of intelligent design…

A big reason this is all possible is because nature has given us a very simple template to work with. Not only does the genetic code have just four letters and 64, three letter words, but many of its words also have the same meaning. It is this last point that has allowed researchers to futz with the code.

The researchers plan to teach bacteria a new language by co-opting one of the words in the genetic code and giving it a new meaning. There are two things scientists need to do to make this happen.

The first is to replace all instances of one word in the bacteria’s genes with an equivalent word. Now the bacteria’s genes all still code for all the same things but a word has been freed up so it can be given a new meaning.

The second step is to redefine the replaced word. This will probably be done by mutating the cell’s reading machinery using some pretty well established genetic techniques.

Church’s group has nearly finished the first step. They managed to create four strains of bacteria each with ¼ of all 314 instances of TAG changed to TAA. They are now in the process of combining these four strains in such a way to generate a single strain with no functional TAG’s. After this first step is done (which should be soon), this group of researchers will be ready to teach these bacteria a new language.

An easy first thing they can do is to change the definition of the TAG so it means the same thing as one of the other words. So the TAG will no longer mean STOP but instead will mean Met or Lys or some other amino acid. (The genetic words or codons really just tell a cell which amino acid to put where in a protein.)

Done correctly, this would probably make the bacteria immune to viral infection.* Which would be a boon for the biotech industry as it loses millions of dollars every year because of infected bacterial strains.

This is pretty pedestrian stuff though. The cool thing will be when they redefine TAG as a word that isn’t already in the genetic code. Then we’ll be able to easily create different proteins with properties useful as medicines, industrial enzymes or who knows what else. At least that is the hope.

And this is just one word. There are another 30-40 codons that may be able to be freed up and given new meanings as well.

We are stepping into a whole new area of research. We are retraining life to do what we want. Let’s hope we know what we’re doing…

*This is because viruses use a cell’s machinery to read its own genes. If the machinery changes, the virus will misread its own genes and die.

Just because a trait is dominant does not mean it is common.
Each color represents different levels of light eyes.
Blue=80%+, teal=50-79%, olive=20-49%, brown=1-19%,
black=none.
Image courtesy of Dark Tichondrias

One of the first things we’re taught in genetics is that some traits are dominant and others are recessive. And that the dominant traits trump the recessive ones.

So brown eyes trump blue eyes. And red hair is always trumped by other hair colors. And so on.

From this, people often jump to the conclusion that the dominant trait is also the most common one. This isn’t always the case and there is no reason it should be.

Whether or not a trait is common has to do with how many copies of that gene version (or allele) are in the population. It has little or nothing to do with whether the trait is dominant or recessive.

Let’s take eye color as an example. The decision on whether to have brown eyes or not is pretty much controlled by a single gene, OCA2.

We can think of OCA2 as having two versions, brown and not-brown. The brown allele of OCA2 is dominant over the not-brown allele.

Nearly everyone in most of Africa has brown eyes. This isn’t because brown eyes are dominant over blue and green. Instead, it is because there are mostly brown alleles of OCA2 in the African population.

Northern Europe is a different story. In some parts of the continent, over 80% of the population has lighter colored eyes. Here the not-brown allele is more common even though it is recessive.

Now this allele isn’t exclusive, there are still brown-eyed folks in northern Europe. So why don’t their brown eyes dominate over time? Because in populations, dominant isn’t dominant over other people’s recessive gene versions. Your brown eyes can’t affect my kids’ eye color unless we get married.

Let’s do a thought experiment to make this clearer. To simplify things we’ll call brown eyes B and not-brown eyes b.

Without some sort of outside pressure,
the ratio of blue to brown eyes stays the same.Remember, you will have brown eyes if you are BB or Bb and blue or green if you are bb. This is because brown (B) is dominant over blue and green (b).

Imagine we start out with eleven bb people and one Bb person. The Bb person has 4 kids with one of the bb folks and each bb couple also has 4 kids.

Using regular old Mendelian genetics, we'll have 20 bb people from our 5 bb couples and 2 Bb and 2 bb from our mixed couple. This is 2 people with brown eyes and 22 people with blue or green. The same ratio as we started with. Brown did not become more common.

Now these folks all pair up randomly and have 4 kids each. Since we aren't going to allow incest, the Bb folks will find a bb for a mate. If they have 4 kids each, then we have 44 bb and 4 Bb. Again the same eleven blue to one brown ratio. Whether an allele is dominant or not does not affect how common a trait is.

Now of course traits can become more common over time. The changes just don’t have anything to do with whether the trait is dominant or not.

If brown eyes gave an advantage, then it would start to become more common. Brown eyes would also become more common if a bunch of Africans moved in or many of the blue-eyed people were killed for some reason (witch burning?). And there are other ways too of getting more brown eyes in Europe. Or more blue eyes in Africa (see South Africa for example).

Dominant does not mean common. Which in some ways is a good thing considering diseases like Huntington’s disease that are dominant.

Why some gene versions are dominant and some are recessive.

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As I have blogged about before, a big part of sexual preference is biological. Research shows that some people are hardwired to prefer the same sex. This is true in animals as well.

What scientists haven’t had much luck at yet is finding out why this is. There have been studies that have implicated the X chromosome (although not convincingly). And others that have pointed to brain structure. But none of these studies really gets at what is going on in these folks’ brains that makes them prefer relationships with the same sex.

A new study out suggests that, at least in mice, the neurotransmitter serotonin may play a big role. Scientists created a strain of mice that lacked most of a certain kind of serotonin receptors in the brain (central serotonin receptors). These mice were healthy and happy. And the males were not at all fussy about whom they hooked up with.

When scientists put wild type* male mice in a cage with other males, they mostly ignored the other mice. The male mice lacking their central serotonin receptors reacted differently. They got busy with the male mice almost every time.

These mice aren’t homosexual though. Given a choice of a male or female, they didn’t really care; they went after both at about the same rate. The genetically altered mice were more bisexual than homosexual.

The researchers did lots of other experiments as well that showed that these mice were not oversexed or lacking anything in particular. They just liked the boys as much as the girls.

What this study tells us is that in mice, serotonin plays a big role in sexual preference through these particular brain neurons. What it doesn’t tell us is if the same thing is true in people. After all, picking a mate is very different in mice as compared to people.

But there are hints that serotonin works differently in the brains of bisexual and homosexual men. For example, certain selective serotonin reuptake inhibitors (or SSRIs) have different effects in bisexual and homosexual men compared to heterosexual men. Still, this isn’t yet enough to finger serotonin use as the main driver of sexual preference in people.

What it does do though is provide scientists some direction for their research. Instead of wading through all 20,000+ genes, they can start out focusing on those that deal with serotonin. This will greatly simplify the research and if serotonin does play a role, then scientists will find the genetic variations involved sooner rather than later.

And frankly, given the slow progress thus far, focusing on serotonin genes won’t set the field back too far. It is probably worth taking the research in this direction.

* Wild type just means a mouse (or any living thing) that hasn’t been tampered with. In this case, it is a run of the mill lab mouse.

A more in depth look at the story from blogger Ed Yong at Not Exactly Rocket Science.

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Who ya gonna call? Stanford Genetics.

I know, I know…hokey title, hokey caption. But in many ways it's true.

Albino redwoods have been called the ghosts of the forest. And scientists from Stanford’s Department of Genetics are on the trail to figure out why these trees have white leaves instead of green.

This all started with a Science on the SPOT story about the albino redwoods by Chris Bauer right here on QUEST. In his accompanying blog post about these "ghost trees", he wondered aloud if any geneticists might be interested in trying to figure out what was going on genetically with these pale trees.

I was intrigued enough that I decided to ask the chair of the Department of Genetics, Dr. Mike Snyder, if he was interested in tackling the problem. By chance, he knew of a scientist in the department, Dr. Ghia Euskirchen, who was also interested in the redwood genome.

In the old days, figuring out what exactly was going on at the DNA level of something as complicated as a redwood would have cost way too much time and money to make a study like this worthwhile (if it was even possible at all). Nowadays things are simpler but still no walk in the park. Instead of elegant, time consuming experiments to pinpoint where the problem might be, scientists will use a more brute force method. They will simply sequence all of the DNA of albino and normal redwoods and compare them.

Sequencing is cheaper, simpler, and less time consuming than the old ways but this isn’t CSI. We’re not going to have answers right after this commercial break. It could still take a couple of years to figure this out. Or, if the biology doesn’t cooperate, even longer.

And the only reason we have a chance to do this so “quickly” is because redwoods can reproduce asexually. In other words, they can throw off clones of themselves.

It just so happens that occasionally, a few of these clones end up albino. What this means is that there shouldn’t be a whole lot of differences between the albino and wild type clones. This should make finding the change that caused the albinism relatively easy. That’s the hope anyway…

I am sure you’ve already started to think how weird it is that a clone ended up different from the original. After all, by definition, clones should be the same.

One letter change turns this watch into a cheap knock
off. The same thing may be going on with albino
redwoods but with DNA letters.In real life, though, clones are not the same as the original. They are more like subtle knock-offs. For example, cloned cats look similar but have different personalities. Same thing with garden variety human clones—identical twins.

So how does a clone end up different from the original? There are many possibilities, here are two:

1. The DNA is different. Even though a clone is really just a copy of the original, cells aren’t perfect at making copies of themselves. You try copying the 30 billion letters of redwood DNA and see how well you do! Most of these changes don’t matter but if one happens to hit and damage one of the hundreds of genes involved in making a redwood green, then you’ll get a white tree.

2. The DNA is used differently. All the cells in a redwood have the same DNA but a root is very different from a leaf. These differences come about because each cell uses its DNA differently. The environment can also affect which gene a cell chooses to turn on and to what level. This is often done with differences in something called methylation which scientists can detect. It may be that methylation has shut off a key gene involved in turning redwood leaves green.

Watch out for at least one more blog on this topic from me dealing with bits of DNA outside of the nucleus that may be involved. And for Chris’ upcoming story on how Stanford scientists are going about solving this albino mystery.

QUEST on KQED Public Media.

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Universal genetic testing may cause the break up of some families.

What became clear to me at a recent meeting I attended is that most everyone is going to have his or her DNA read in the near future. Another thing that became obvious is that scientists aren’t doing enough thinking about what impact this will have on society.

Here’s a seemingly trivial example. In most scenarios I have seen, children‘s DNA is read as soon as they are born. This will definitely have some huge health benefits especially as we learn more and more about how our DNA works and what it means. But this will also have some big unintended consequences too.

Parents will know both their kids’ and their own DNA. From that it will be pretty easy for most anyone to piece together whether or not a child is related to them. In other words, if everyone knows their family’s DNA, then every family will automatically undergo a paternity test. And if some statistics I have seen are true, then a whole lot of people are in for a nasty surprise.

The most recent numbers that I have seen are that something like 3-4% of fathers are unknowingly raising kids who are not their own*. Universal DNA testing will undoubtedly spill the beans in these cases causing many families to break apart.

This “misattributed paternity” is not an unknown problem today…genetic counselors deal with this sort of thing in their practice on occasion. Genetic counselors struggle with what to do with this collateral information and have the option of not revealing it to their patients. Withholding this information won’t be an option in a future where families know their DNA.

So in the not too distant future, up to one million dads in America will find out that little Susie or Jimmy isn’t theirs. Some will be able to deal with this but it will tear many families apart. This will obviously have a huge impact on society.

There will be more subtle effects too. Both men and women will quickly figure out that paternity won’t ever be a secret any more. If you have an affair and have a child, you will be found out.

Will this knowledge work as a sort of moral police, preventing people from having affairs? (Probably not.) Will people be more careful about contraception? Will abortions increase to cover up affairs?

As you can see, just knowing this little bit about our DNA will have profound effects on society. And I haven’t even talked about how medical care and the insurance industry might be restructured. Or how it will affect who you decide to have kids with. Or…

* This is the latest estimate I could find which is much less than the 10-30% number that med school students used to be taught. We won’t have an accurate number until more genetic testing of families is done.

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If you’re an adult and you can drink milk, then you are a mutant. Image courtesy of Collectie Willem van de Poll, via Nationaal Archief.

Over the last couple of weeks it has become obvious that my daughter is lactose intolerant. In most of the world, that wouldn't be a big deal. One study I saw claimed that at least 3 in 4 adults worldwide are lactose intolerant. And in some countries (like Thailand), over 99% of adults can’t drink milk as an adult.

This makes sense since lactose intolerance is the norm for mammals. Humans are one of the few animals where a sizable minority of adults are lactose tolerant. Scientists have noted this and have renamed the Eurocentric "lactose intolerance," lactase persistence.

Sigh, scientists never make things easy do they? Why not call it lactose tolerance so everyone understands?

They named it lactase persistence because of how lactose is digested in our bodies. Lactose is digested by the enzyme lactase and lactase persists longer in people that are lactose tolerant. Hence, lactase persistence.

Our cells make lactase by reading the lactase gene. In most mammals, this gene gets shut off in adulthood.

The programming for turning the gene off later in life is found in the DNA around the lactase gene. People with lactase persistence have a DNA change that messes with the programming. Now the lactase gene stays on so these folks can keep drinking milk and eating ice cream.

The “on” version is actually dominant over the normal one. In other words, lactose intolerant people need to get the normal lactase gene from both parents. So my wife and I are at least carriers—we can drink milk but carry one normal lactase gene.

I actually know that I am more than a carrier. I have two normal lactase genes even though I can still drink milk. This means that my gene hasn’t shut off yet but that it probably will at some point. Scientists don’t yet know why it shuts off early in some people like my daughter and later for others like me.

So how did some people end up able to drink milk as adults? Mutations and natural selection of course.

Most likely there is always a low level of lactase persistence in any mammalian population. Mutations (or new DNA changes) can and do happen and changes like this in the lactase gene are bound to be pretty neutral. In most situations there won’t be any advantage or disadvantage to having it and so it will stay rare.

This can all change if adults suddenly have to start drinking milk as happened in certain cultures in Europe and Africa. In these places, the few people with the right lactase mutation had an advantage and so did better than the lactose intolerant. Eventually, most people in these places could drink milk as an adult.

What is really interesting to me is the fact that European and African milk drinkers don’t share the same DNA difference. Each population had a distinct lactase mutation that became the norm. This is called convergent evolution—two populations arrive at a similar trait with different DNA changes.

However it happened, my daughter is now adjusting nicely to the milk-soaked culture she finds herself in. There are pills that let her drink milk as well as lactase-treated milk and ice cream. This means she can still have her favorite dessert in the world, chocolate ice cream.

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A few minor tweaks to genetic testing companies' websites could make their offerings more transparent to the public and the FDA.

The last couple of blogs I have been talking about direct to consumer (DTC) genetic tests. I talked about how the FDA has begun looking into them and why the FDA isn’t happy with what it sees.

In this blog I thought I'd propose a couple of different ways these DTC companies can present their data that might mollify the FDA. These changes will also let consumers know what they're really getting and whether they want it at all.

Before starting, I want to say that I will focus on 23andMe, a Bay Area company. I'm not picking on them. They are just the company I know best and one of the few that is good enough to survive the FDA's scrutiny. I also know a lot about them because I have taken their test.

23andMe has a very good website. They present complicated data in an understandable and easily searchable way. Their major weakness, though, is that they implicitly promise more than they can actually deliver. In essence, even though they are pretty good about disclaimers, they aren't good enough.

One of the first things the company should probably do is to reorganize the first page that potential customers see. They need to make sure that potential customers have a good idea about what they can and can't get from these sorts of genetic tests.

For example, right now a prominent feature is a box that lets the viewer search for the diseases 23andMe “covers” along with a list of popular topics. People may come away thinking 23andMe has useful tests for most of the diseases listed. They don't.

They have some useful tests for a few, rare genetic diseases. But the bulk of their tests are not at all useful yet in figuring out someone’s risk of getting a certain disease. What they have for the more complicated diseases is a way for people to compare their DNA to various studies in the scientific literature.

Maybe a study was done that found a DNA difference involved in diabetes. Customers can see whether or not they have this difference too but this tells them nothing about their risk for diabetes. It gives just one piece of a giant puzzle. They are not getting any meaningful results that can predict their risk for diabetes. This box should probably be heavily modified or even eliminated.

In fact, the website really should be organized into different sections that are labeled by how medically useful they are to the customer rather than by how strong the DNA study was scientifically. Maybe they could split their tests into three sections.

The first would be carrier testing. These tests can tell you if you have a hidden genetic disease that you could pass down to your child if your partner has it as well. This would get high marks for reliability, scientific validity, and usefulness.

The next section would be more fun related stuff. This would have ancestry and some of the traits testing. It would be able to tell you what your earwax is like, where your mother's, mother's, mother's, etc. mother came from, the odds that your child might have blue eyes, etc.

The final section would include the bulk of what is tested. These are the tests that compare your results to results in the scientific literature for complex diseases. Many of these tests would score high in scientific validity but get no points for usefulness. As I said before, most if not all of these tests will not give you an accurate risk assessment for the diseases they look at. Period.

There isn’t any reason these results shouldn’t be included, though. Maybe people enjoy seeing the results or want to use them to watch progress in the field or whatever. But the companies need to say upfront that these tests are not that useful for determining risk. This needs to be obvious enough that someone wouldn't buy the product just for that test.

As a last point, 23andMe (and all genetic testing companies) need to be much more upfront about what their tests can offer based on race. The carrier tests are probably pretty good for most everyone (although they may miss any nonwhite versions of many diseases). The fun section might be pretty useful to the nonwhite world for ancestry but probably less so for traits as they have mostly been determined for people of European descent.

Most of the rest of the tests they offer that deal with more complex diseases have only been validated for white people. This needs to be explicit on their website so nonwhite people know they aren't getting as much bang for their buck. Buyer of color beware!

These kinds of changes will go a long way towards making these sites more transparent to potential customers. And they may even keep the FDA at bay.

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Could you guess what this is from one of its hairs? That’s about how predictive current genetic tests are for complex diseases like prostate cancer or heart disease.

As I talked about in my last blog, direct to consumer (DTC) genetic tests are taking a beating right now from the FDA. Part of the problem has to do with some snake oil salesmen contaminating the whole field. But part of it has to do with the data that is available right now and how it is presented.

In this blog, I’ll deal with the data itself and why the FDA has such a problem with it. Next blog I’ll try to come up with ways to still get that data to consumers without ruffling any regulatory feathers.

A big problem with some of the current tests is that people will get different results based on the company they use. For example, the FDA reported that the same man was told he had an increased risk, the usual risk and a decreased risk for prostate cancer depending on the company he used. The FDA hates this kind of stuff.

To them (and many people), these kinds of results say that these tests aren’t working correctly. And given their experience with medical testing, they’re right.

A real medical test should give consistent results. If you take a test that looks at your cholesterol levels, your heart attack risk should be the same no matter who administers the test. Or if you take a genetic test to see if you are a carrier for sickle cell anemia, then again the results should be the same no matter who does the testing.

The genetic test for prostate cancer isn’t anything like these tests because it isn’t a medical test at all. It would be kind to even call it a work in progress. It is really just some interesting information at this point.

This is because we don’t have a good handle on the genetic risks for prostate cancer risk. There are almost certainly lots of different glitches in lots of different genes involved in increasing someone’s risks for getting prostate cancer. All of these variations need to be factored into a man’s risk for prostate cancer. And we only know about a few and those few have a pretty limited impact.

To add to the problem, different companies also look at different glitches or SNPs. So one company might look at one or two SNPs and say a man has a 1.2 fold increase in getting prostate cancer. And another might look at a different two and say he has a 1.1 fold decrease in getting prostate cancer. Different results but neither is particularly meaningful in predictive sort of way.

It is a little like trying to figure out what an elephant looks like from just the tip of its tail. And comparing that result to someone using an elephant’s eye lash to figure out the same thing. Odds are you’re not going to end up with the same animal. Just like you won’t end up with the same result from these kinds of genetic tests.

So when you have one of these tests done for complicated diseases like prostate cancer, diabetes, back pain, heart disease, etc., you’re only getting one piece of genetic information when you need 10 or 100 to figure out your actual risk. You have the eyelash or the tip of the elephant’s tail instead of the whole skeleton.

Now I don’t want you to walk away thinking that I am advocating that these companies shouldn’t give customers these results. I’m not. People should have a right to this information if they want it.

What I am advocating is that these companies come up with some way to explicitly state that these kinds of results are not useful medically. They need to be careful how they present the tests they offer and how they present the results. They don’t want to inadvertently lure customers into taking a test that can’t give them what they want.

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Maybe the FDA could set up a sort of Consumer Reports for genetic testing.

Over the last few years, a bunch of companies have sprouted up that offer genetic testing over the Internet. The most controversial of these are the ones that offer consumers the chance to predict their future health risks.

These particular direct to consumer (DTC) tests took a real kick in the teeth from Congress this month. It was a big enough wallop that I don’t think the companies will be able to survive in their current form. The real question now is what they will look like when all of this shakes out.

There has been some low level concern by the FDA about this sort of testing for quite a while now. But what really focused their attention was when a small company from San Diego made plans to offer their test through Walgreens. What the FDA saw was a test that promised more than it could deliver.

To be honest, this is true in one way or another about most if not all of these genetic testing companies. Few of them are able to deliver everything that many consumers think they can.

So the FDA has set out to right this wrong. Unfortunately, because of the industry’s lack of organization, the FDA lumps all these testing companies together. This is not fair.

Some companies like 23andMe, deCODEme and Navigeneics are basically good companies that need some FDA guidance. Other companies are rip-offs that should be shut down. One of the genetic testing industry’s tasks now is to provide the FDA with the tools to distinguish between these two groups of companies.

What might help is some sort of Better Business Bureau for genetic testing. Or maybe some sort of self policing umbrella organization that only the best companies can join. Or some outside group that evaluates each company. Any of these would help both Congress and consumers have a better idea about which companies they should use for their testing.

These companies can already be CLIA certified but that isn’t necessarily that helpful from a results perspective. It is important in that it tells a consumer that the company runs the tests very well according to professional standards. What it doesn’t do is tell consumers which claims are believable, which ones are iffy, and which ones are straight out lies.

Even though it will be very tricky to police the results, these companies need to figure out a way to do this or they’ll continue to get lumped together. And consumers will lose the chance to get testing through some of the better companies.

Maybe the FDA could set up a sort of Consumer Reports for genetic testing. It would be staffed by a few genetic scientists who would look at the scientific merit of these tests and determine whether the claims are true or not. This would then be published on a website and companies that were up to snuff would get a seal of approval.

Right now I don’t think any company except maybe DNA Direct would get that seal. So maybe we need some sort of rating system instead. One DNA helix means stay away, five means a perfectly legitimate company, etc. This could let consumers know which are the better companies without the FDA having to straightjacket the industry into irrelevance.

I'll tackle the problem of interpreting and presenting data in my next blog. What I’ll try to do is propose some ways to present the data so that any potential customers won’t be bamboozled (or at least minimize the risk).

Before I leave, I do want to voice a word of caution. A working assumption in the discussion here is that the better companies are pretty good. A sting operation by the GAO (no, really) may cast some doubt on this.

As you listen to this YouTube video, think about the fact that the first example is from Navigenics, one of the good companies. The good ones need to be more careful with their communications to the public or they may be wrongfully lumped in with the bad ones. Or with too many examples like this, maybe I should say rightfully…

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Results like these get a company noticed by the FDA. (Click the image for a larger version.)

A month or so ago a small company in San Diego struck a deal with Walgreens. Together they were going to sell genetic tests directly to consumers from drug store shelves. Sort of like how some paternity tests are now sold.

The resulting furor has caused Walgreens to back off. It has also awakened the slumbering beast—the FDA.

Last week the FDA sent a letter out to five different direct to consumer genetic testing companies about the genetic tests they offer. The FDA is arguing that these genetic tests are medical devices and therefore it has the authority to regulate them.

These tests actually consist of thousands of individual tests. If the FDA wants to regulate each one separately, there is no way that these companies will be able to make a profit. They’ll have to raise prices beyond what most people are willing to pay or simply fold up shop.

This is probably why companies like 23andMe and deCODEme shied away from medical sorts of tests before and instead focused on recreational genomics. They offered tests to learn about the DNA behind your earwax, lactose intolerance and lots of other little, fun traits. But people would learn very little about their disease-causing DNA.

The companies must have found that they had trouble finding enough people willing to plunk down 400 or 500 dollars for a fun genetic test. A new TV, iPhone, Wii are all more fun and cheaper.

So to scare up some customers, the companies began to offer more medical information in these tests. Undoubtedly they thought that people would be willing to pony up 400 dollars to learn about their risks for diabetes, heart disease, lots of rare genetic diseases and much more. A bargain by any standard!

Leaving aside the fact that most of these individual tests aren’t as useful as you might think, including medical tests introduces another problem. Including medical tests puts these companies square in the sights of the FDA which is not known for its liberal attitude towards medical devices.

To get enough customers to stay profitable, these companies need to offer medical tests. But if the FDA regulates these tests then the profits will go away. Or the companies will have to charge a lot more money which will drive customers away. A Catch-22 if I’ve ever heard one!

These companies may need to provide detailed evidence for each individual genetic test. Many of them probably won’t stand up to the FDA’s scrutiny and will have to be removed. Let’s hope for their sake that the remaining ones are still interesting enough to consumers. If the companies can survive the cost of complying with the FDA that is…

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