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Thursday, July 14, 2016

Harmonyx Genetic Test Runs Into Trouble With FDA

The FDA has recently issued a  letter to the makers of Harmonyx, a pharmacogenetic test that can be used to help determine the best medication to use for ADHD.  This letter cites concerns that the test is being marketed without appropriate FDA clearance.

The company has voluntarily pulled the test from the market as it cooperates with the FDA in its' investigation of the matter.  However, the company denies that the test is being marketed directly.to consumers, and states that it believes that it is in compliance with the FDA's regulations.

11/10/2016
Harmonyx issued a letter to consumers stating that they will not be offering testing anymore because of the overwhelming costs associated with pursuing FDA approval for direct to consumer marketing.

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