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Tools & Techniques Diagnostics & prognostics

The Truth About Personal Genetic Tests

Direct-to-consumer genetic tests like 23andMe have evolved substantially in the last decade, faster than society’s ability to comprehend their medical, scientific, and ethical implications.

The path for 23andMe has been a rocky, convoluted one as it initially struggled to balance its business interests with regulatory requirements. The company started with a much larger 250+ gene assay that, in addition to testing for genetic ancestry and lighthearted traits, such as eye color or the ability to smell asparagus, tested for BRCA genes and genes associated with alcoholism, obesity, Alzheimer’s and Parkinson’s. In November 2013, 23andMe was temporarily shut down by the FDA for failing to prove its assays were accurate and reliable despite numerous requests. It was a harsh but necessary move by the FDA. As any physician knows, the first questions about any assay are: how reliable it is? What are the positive and negative predictive values? Is the result clinically meaningful?

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About the Author

Suneel Deepak Kamath

Suneel Deepak Kamath is Hematology/Oncology Fellow at Northwestern Memorial Hospital, Chicago, USA.

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