You may have read in the news in the past several weeks that the FDA has ordered personalized genetic testing company, 23andMe, to halt the sales of it’s $99 home genetic test.  The company’s test provided an affordable means of detecting multiple genes that can benefit people in their ongoing medical care and quest for optimal health.

One of the genes it looks at is the MTHFR gene.  Thirty percent of caucasians have an alteration of this gene, causing a much higher biologic need for folate than those who do not have the gene alteration.  Not meeting the body’s demand for folic acid can have deleterious health effects and can play a role in both depression, heart disease, and development of neural tube defects in unborn children.  Testing for alterations in this particular gene can be beneficial in forging a treatment plan to treat or prevent disease.  I can order this single gene test through our hospital, at a cost of $175.  I can also order it from a different outside lab for substantially cheaper, $48, once again to test for that gene only.  In my experience thus far, no insurance company has been willing to cover the cost of testing for this particular gene, leaving patients to cover the cost of this test out of their own pockets.

The service 23andMe provides gives results for multiple other genes as well.  Other genes it tests for include a set that codes for enzymes that metabolize drugs.  If there are alterations in these genes, you may need more or less of a certain medication to achieve the therapeutic effect.  Drugs now are prescribed by standard doses, a “one-size-fits-all” approach.  With patients who have genetic variations in these drug metabolism genes, they may not tolerate a particular drug or others may not have a medication work for them at standard doses.  Good medicine would test a patient’s genes and dose medications accordingly.  This idea is before its time but is currently available to cash-paying patients.  I can also have these genes (the same ones included in 23andMe’s test) tested for by a lab company for around $400.  Once again, this test is not covered by insurance.

23andMe’s test covers many, many genes beyond those discussed above as examples.  It provides therapeutically pertinent information at a much reduced cost for what other companies are offering these same services for.  From what I can ascertain from the media coverage of the FDA’s crackdown, the concern they have with 23andMe is their marketing claims and interpretation of test results they provide consumers.  To the best of my knowledge, the validity of the test is not being called into question by the FDA.  I have been unable to find a copy of the letter the FDA sent to 23andMe and 23andMe’s statement on their blog does not elucidate the nature of the FDA’s claims against them.


While the use of genetics in clinical medicine is still in its infancy, my hope is that these two organizations can resolve their dispute quickly and that the public may continue to purchase potentially useful and life enhancing genetic testing at a low cost and in a manner that is safe and enhances the health and well-being of patients.  There are other direct to consumer genetic testing companies out there but 23andMe is the one I am most familiar with.  The resolution of the dispute between them and the FDA will set a precedent for direct to consumer genetic testing services in  the future.
 


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