A Different Kind of Direct Sale: Direct-to-Consumer Genetic Test

What is Direct-to-Consumer Genetic Test?

According to the National Institutes of Health’s (NIH) Genetics Home Reference website, direct-to-consumer (DTC) genetic test involves a direct to consumer marketing and sales tactics that bypass the engagement of the health care professionals such as medical doctors, nurse practitioners, or genetic counselors.  In general, consumers order test kits online or through mail, and send in requested samples back to companies; then the test results are sent directly to consumers with minimal consultation and interpretation from health care professionals.

Personalized Medicine Fuels The Development of The DTC Genetic Tests

When the alliance between the NIH-sponsored laboratories and Celera Genomics jointly announced the completion of sequencing the draft of the human genome in 2000, many have predicted the coming era of “personalized medicine”.  The idea is to develop and prescribe a treatment plan or drug based on the information encoding in each individual’s genome.  As a result, personalized medicine tailors individual’s intrinsic differences to improve diagnostics and treatment of diseases.  With the advancement of faster and less expensive DNA sequencing platforms, getting DNA information is easier than ever.  In a sense, the growing numbers of the DTC genetic test products are likely inspired by personalized medicine, a Holy Grail of future medicine.

Who Jumps on The Bandwagon of The DTC Genetic Test

It is a fast-growing market place for at home DTC genetic test that comes with garden varieties of selection. Tests include risk evaluation of diseases like Parkinson, Alzheimer’s, asthma, breast cancer, diabetes, gluten sensitivity, ancestry tracing, drug responsivity, and whole genome scan, etc.  So far, there are 20 companies receiving the FDA’s letters concerning their genetic test kits as medical “devices” that require data-driven regulatory review and postmarket monitor.

Can FDA Come Out a Win-Win Regulatory Policy?

Currently there are already many do-it-yourself at home tests on the markets, such as blood-sugar meter, home pregnancy test, or home colon-cancer-screening test kit, just to name a few.  So what is it so concerned about DTC genetic test?  It is crucial to understand that in all scientific measurements, there are intrinsic errors in sample selection/representation, technology platforms, or statistics inference.  One has to understand the perils of being misled or misinterpreted by the genetic test results, due to test errors (false positive or false negative), excessive claims (based on unproven study), or unrealistic risks/benefits.  It is time for the FDA to come out a clear regulatory policy to protect consumers from getting incorrect information and potential losing privacy, and at the same time to validate safety and effectiveness of company’s test device/kit as well as to monitor proper disclosure of risks and benefits of test results.

Until next post, keep on reading and writing!!

About fdabiomed
I like to read, organize, and write about biomedical related topics. I am passionate to learn new things, particularly news related to the Food and Drug Administration's decision and announcement, as well as the decision impacting on company's stock price.

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