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DNA Helix

Posts Tagged ‘23andme’

FDA sends letters to 5 genetic testing companies

It appears that the FDA sent letters to several different direct to consumer genetic testing companies. They are 23andme, Navigenics, DeCode, Illumina, and Knome, which provides whole genome sequencing. The FDA is claiming the tests must undergo approval as a medical device, but did not say anything about removing them from the market. The article also mentions that Pathway Genomics, the company producing the genetics tests that Walgreens considered selling in its stores, also received a letter.

Having recently received my 23andme results, I’m a little concerned by this statement:

Concern about the tests was also raised this week when 23andMe said that because of a laboratory mix-up, up to 96 customers might have received genetic information belonging to someone else.

I certainly hoped that they notified these customers of the potential error…

Why the DTC companies will fail…or not?

There have been plenty of other posts here on Think Gene foretelling the failure of the DTC market, such as free microarray tests. The consensus is that for these companies to survive, they must enter the medical market.  Critics will say that while companies such as 23andme, Navigenics, and deCODE are just waiting for the right time to enter the medical market, I think there is a different reason why they haven’t entered this market: malpractice.

Let’s first examine the issues in pharmacogenomics with genetic testing. There’s a very well written academic paper by Gary Marchant titled Legal Pressures and Incentives for Personalized Medicine. Additionally, at Redorbit, Olga Pierce writes:

Thus far, lawsuits based on a failure to offer genetic testing before prescribing a drug have mainly targeted drug manufacturers’ deep pockets. But drug companies have circumvented legal problems by including information on genetics and the potential danger of the drugs in package inserts given to consumers with their medication.

That means doctors have become the new targets, Marchant said. It’s a short matter of time before we see a new wave of these cases. Juries are going to say ‘you should’ve done something different.’

But doctors are faced with a catch-22, he said. Most health insurance plans do not cover such genetic tests. If patients cannot afford them, the doctor must decide whether to risk malpractice allegations or simply not prescribe a potentially helpful medication.

Doctors are in a very difficult position, Marchant said.

Doctors’ general lack of training in genetics makes matters worse, he added. Anybody practicing medicine in the country in the next ten years has to understand genetics — or go out of practice.

Institutions and professional organizations can help by establishing clear guidelines for when genetic testing is required, he said, and medical schools should offer new doctors more genetics training.

Nonetheless, there will be a dangerous period for doctors, he said. It’s doctors that are going to bear a lot of the risk during the transition period.

So doctors are liable if they do not give a genetic test when one is available and it may help with prescribing medication. An example is Wafarin/Coumadin, which Dr. Steve Murphy talks about often at his blog, where people can have extremely adverse side effects if they have a particular genotype.

If a doctor did have the genetic data and still prescribed the medication, then it would be pretty clear grounds for malpractice.

Now imagine if a doctor or institution had access to a full microarray of genomic data (including high penetrance mutations). On the one hand, it would be great because if a doctor is prescribing Warfarin, he can easily check the genetic data on file to see if Warfarin is an appropriate medication for the patient. On the other hand, what about mutations that aren’t widely known yet but can be used to determine adverse reactions to drugs such as Warfarin?  If the data is on file, regardless of whether the doctor knows about the mutation, then he may be held liable for malpractice. Negligence could be argued.

This poses quite a problem for the current SNP microarray testing companies. Why would doctors get a whole genome scan which could potentially put them at higher risk for malpractice when they could simply order individual tests? It costs more, but it keeps them safer.

I now propose a simple solution: involve a third party. Say a doctor at a hospital orders a test for Warfarin. The cost of doing a microarray is essentially the same as doing a single genetic test, but the hospital doesn’t want all that data on file. Instead, a third party can do the test and instead only give the hospital access to the specific region that request. In addition to malpractice issues, the other reason for doing it this way is to reduce the cost of licensing fees; why pay the license fee for a BRCA1/2 test if it’s not actually needed? If another doctor later requests a BRCA1/2 test, it can be made available immediately without having to perform another test, and the patient or the patient’s insurance is billed accordingly.

This leaves the microarray DTC providers in quite a bind though. They spent significant resources to develop their genome browser, which is really what gives them their competitive advantage in the DTC market. However, this genome browser doesn’t help them in the medical arena, and in fact may even hurt them for the reasons stated above — information overload and malpractice liability from it.

I don’t want a 23andMe — I want the real genetic tests

Our friendly government lists some available genetic tests: these are the real deal, high penetrance tests for things you already have or conditions you will get.

Unlike Sergey Brin, I don’t particularly care about a mutation that gives me a slightly increased risk for a disease. That’s not significant, though if the placebo effect of a 23andMe test gets you to exercise more, congratulations.

However, if I knew I was bound to get Huntington’s Disease, I would really live my life differently with the moral superiority provided by knowing that my time on this earth was sadly limited by my genetics. I would just take things so much more seriously than all those suckers blissfully unaware of the cold, cruel nature of reality.

For now, it’s prohibitively expensive to get every single genetic test. With how much I would have to spend today to get 50 patented tests I would be better off waiting a year and getting my genome sequenced, then analyzing the data myself to (illegally?) check for every high penetrance mutation.