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FDA States Genetic Tests Are Considered a Medical Device And Thus Need FDA Approval

Posted Jun 11 2010 9:45am

The companies who market and provide the interpretations of course are not the processing end of having your genes sequenced.  They are sent out to a company that has the “machine” that does the processing.  The results of the sequencing are returned to the company for the interpretation process so this involves more than just the company doing the interpretation.  Last week 23AndMe was in the news over a mix up with interpretations being given to the wrong individuals. image

The mix up as what has been posted occurred at the location where the sequencing process was done.  I spent many years in logistics and mix ups with shipping are a common occurrence, but with technology in the last few years it is becoming less of a problem.  Logistics companies invest heavily with technology for tracking, etc.  From what I read it appears that someone at the processing end mislabeled the results with the wrong name, and thus it rolls downhill from there, so the logistics portion appears to be ok, it’s just that the orders and names were mixed up and yes it is still a human that does labeling here.  I did an interview with Helicos, one of the companies that makes the “sequencing machine” and you can find out more about the machine process at the link below.

Helicos BioSciences and Personalized Medicine - Featured Interview with Dr. Patrice Milos

In addition, back in December 2008 I had a post that covers some of the areas of interpretation. 

So in essence, that “box” you get to submit your DNA for testing is now considered an extension of the sequencing machine to be called a medical device.  I know it sounds a bit strange that the “box” is now a medical device, but it is the combined process that lead the FDA to categorize testing companies as marketing a “medical device”. 

With sending letters to the 5 companies the FDA is asking each to submit their tests for FDA review.  DNA testing is becoming very entangled in many areas of our lives today as police agencies are using it to identify and help solve crimes too, which is a different interpretation without a full genetics background, or least as we image know to date, and who knows if areas like that will expand too and how much information they really gather and analyze too. 

FDA Listing of In Vitro Diagnostics - Letters Sent to 5 Companies

I somewhat look for that area of testing to enter into this arena in time as analysis information seems to be a huge addiction and once people have a taste of this, they want more.  Many cities and municipalities are starting DNA banks too so that part of the process will be interesting to watch as well to see when the healthcare/crime solving paths of DNA processing begin to cross at some point and privacy issues come in to play there.  

Basically with consumer marketing with getting some general sequencing provided the FDA is concerned about further mix ups as that is what seemed to ignite this situation along with retail drug stores wanting to sell the “box” on the shelf.  This error factor that occurred also shows the importance of using bar coding and RFID to ensure samples are not mixed up when identifying the owner at the “machine” level too.  Not too long ago, Provenge the prostate cancer vaccine was in the news of being approved by the FDA and part of their process in providing “safety” was to ensure a tracking system so errors did not occur as such.  Now of course here we are talking a very expensive procedure with blood samples and a cancer drug, but the process of tracking and ensuring the property identify are the same.

I have several posts on this blog about Tags, 3D bar coding and when keeping track of lab samples we need this today as labs are busy places and doing a lot of testing and the FDA in fact should look into this for a process of recalls too, which today is cumbersome and relies on people reading their website for official notices.  Once your test is submitted, you the consumer get your Tag to trace as well as the company providing the DNA research services for you.  We do this with parcels, so why not DNA testing.  It would actually give credibility to the company doing the DNA testing and keep their contracted processors on their toes too just knowing you the consumer is checking for status all along the way of handling your order.

In the meantime the FDA wants the companies to submit their processes for approval since they are now considered a device.  This is not unusual as recent efforts at the FDA considered Cheerios a drug, again coming back to their marketing campaigns and what they advertised so we may see some additional classifications like this in the future too.  BD

WASHINGTON - The Food and Drug Administration is issuing regulatory letters to five genetic test makers, the first sign that the government is cracking down on companies that claim to use DNA samples to predict inheritable diseases.

The letters posted online deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc.

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