The U.S. Food and Drug Administration ( FDA ) annunciate Wednesday that it has approved the merchandising of 23andMe ’s reports on pharmacogenetics , which the familial - testing company claims are designed to measure whether genetics may affect an person ’s power to metabolize certain drugs include antidepressants .
The company ischaracterizingthe move as the “ first authorization of a lineal - to - consumer report on pharmacogenetics . ” But with the approval of 23andMe ’s Personal Genome Service test also issue forth a routine of caution , the most glaring of which being that the trial is mean to facilitate conversations with healthcare professionals rather than inform any form of final word on medications or treatment .
“ This test should be used appropriately because it does not set whether a medication is appropriate for a patient , does not provide aesculapian advice and does not name any health condition , ” Tim Stenzel , music director of the Office of In Vitro Diagnostics and Radiological Health in the FDA ’s Center for Devices and Radiological Health , said in astatement . “ consumer should not habituate this test to make discourse conclusion on their own . Any aesculapian decisions should be made only after discuss the results with a accredited health care provider and upshot have been confirmed using clinical pharmacogenetic testing . ”
The FDA says the test are n’t intend to be used to inform the recommendations for treatment by a supplier , valuate a patient role ’s ability to reply to medications , or even be read without extra “ independent pharmacogenetic testing . ” The genetic - testing startupsaidWednesday that the peculiar controls associated with the authorization for 23andMe to commercialise the test are meant to “ ensure refuge , effectiveness and accuracy . ”
“ We ’ve continue to introduce through the FDA and pioneer good , good pathways for consumers to directly get at hereditary health information , ” 23andMe co - founder and CEO Anne Wojcicki say in a statement . “ Pharmacogenetic reports are an important category of information for consumers to get accession to and I believe this authorization open up the door for consumers to work with their health supplier to well manage their medications . ”
23andMe is only the latest in gene - examination companies to get in on pharmacogenetics news report . byplay Insiderreported earlier this month that more than two dozen Albertsons chemist’s shop in Chicago , Philadelphia , and Boise were offering such tests as part of a pilot program with the company Genomind . It also say 23andMe competition Color Genomics recently get offering its own pharmacogenomics product with its $ 250 test . But the trial do have their critic , some of whom told Business Insider that the tests may not be best than the tribulation - and - wrongdoing method .
“ I do n’t needfully postulate to eff up front if a soul is a poor drug metabolizer . I take to know which specific drug to use where I will get the irrefutable event with less side effect load , ” Alan Schatzberg , a Stanford University psychiatrist and the managing director of the Stanford Mood Disorders Center , say the site . “ These tests do n’t do that . ”
The other reason genetic - examination outfit — and specially straight - to - consumer kit — can be problematic are because they can lead to confusedness when it amount to assessing possible risks .
“ Even if you quiz negative for all recognise [ disease ] genes , your risk for that disease may still be increased ground on your family story , ” Mary Freivogel , chairwoman of the National Society of Genetic Counselors , toldStatlast year . “ A negative 23andMe trial might provide assumed authority . ”
As is likely the indication from the FDA , it may be best to take any familial - testing outfit with agrain of salt .
[ FDAviaBusiness Insider ]
23andMegenetic testingGeneticsMedicationpharmaceuticalsScience
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