US FDA sends let­ter to DNA4Life over con­sumer gene tests

Kuwait Times - - HEALTH & SCIENCE -

NEW YORK: The US Food and Drug Ad­min­is­tra­tion sent a let­ter to pri­vately held gene test­ing com­pany DNA4Life over the com­pany ’s sale of an unap­proved direct-to-con­sumer gene test to pre­dict drug re­sponse. In its let­ter, posted on Mon­day, the agency said it was un­able to iden­tify any FDA clear­ance for the com­pany’s test. The let­ter fol­lows 23andMe’s lim­ited re­launch last month of a se­ries of direct-to-con­sumer (DTC) tests af­ter the agency or­dered the tests off the mar­ket. DNA4Life told Reuters in an ear­lier in­ter­view that it did not be­lieve it needed FDA ap­proval to sell its test. DNA4Life, based in Mandeville, Louisiana did not im­me­di­ately re­spond to re­quests for com­ment.

In its let­ter, the FDA said the com­pany’s test ap­pears to meet the def­i­ni­tion of a med­i­cal de­vice, which re­quires mar­ket­ing ap­proval. The agency said the com­pany needs to pro­vide ev­i­dence that the de­vice has been ap­proved or in­for­ma­tion re­gard­ing why it be­lieves the test does not re­quire FDA ap­proval. In a state­ment sent to Reuters last week, FDA spokesman Eric Pa­hon said the FDA be­lieves that “cer­tain types of tests are be­ing ap­pro­pri­ately of­fered through the DTC model, but oth­ers may need to demon­strate that they are safe and ef­fec­tive and that ap­pro­pri­ate con­trols are in place to mit­i­gate risks.”

The let­ter comes in the wake of 23andMe’s two-year tus­sle with the FDA over its direct-to-con­sumer per­sonal DNA test­ing ser­vice, which the FDA or­dered off the mar­ket in 2013. Last month, 23andMe re­launched its ser­vice with a lim­ited num­ber of ge­netic tests for car­rier screen­ing - tests that show whether an in­di­vid­ual car­ries genes as­so­ci­ated with 36 dif­fer­ent disorders that could be passed on to a child. 23andMe still does not have FDA ap­proval to re­sume the sale of tests that pre­dict drug re­sponse. Ex­perts in phar­ma­co­ge­net­ics be­lieve those tests could be much riskier in the hands of con­sumers, who might use the in­for­ma­tion to make de­ci­sions about the drugs they are tak­ing. —Reuters

AD­DIS ABABA: A pic­ture taken on Novem­ber 9, 2015 in Nairobi shows a mo­bile phone ap­pli­ca­tion offering a sim­pli­fied guide to child-birth in Ethiopia, dis­played on top of an Ethiopian flag. —AFP

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