Mix-ups fuel de­bate about reg­u­la­tion of ge­netic test com­pa­nies

Austin American-Statesman - - WORLD & NATION -

One woman pan­icked when the ge­netic test she or­dered over the In­ter­net con­cluded that her son was car­ry­ing a lifethreat­en­ing dis­or­der — and that he wasn’t ge­net­i­cally her son. An­other woman’s ge­netic test re­sult was even more stun­ning: She was a man, it said.

“I thought, ‘Oh my god. Am I re­ally a man?’ ” said Denise Wein­rich, 48, of St. Peters, Mo. “DNA doesn’t lie.”

DNA may not lie, but Wein­rich was one of 87 peo­ple who re­ceived in­cor­rect re­sults last month be­cause of a lab mix-up in­volv­ing cus­tomers of test­ing com­pany 23andMe. The Moun­tain View, Calif., com­pany says it spot­ted the mis­takes quickly, no­ti­fied the clients and has taken steps to pre­vent fu­ture er­rors.

But the blun­der has fu­eled a de­bate over whether the govern­ment should bet­ter po­lice the pro­lif­er­at­ing tests. “It’s come to the point where re­ally there’s a need for some over­sight,” Food and Drug Ad­min­is­tra­tion of­fi­cial Al­berto Gu­tier­rez said.

“If you have things com­pletely un­reg­u­lated, then you have a Wild West of com­mer­cial in­ter­ests around med­i­cal in­for­ma­tion,” said Robert Green, chief of Bos­ton Uni­ver­sity’s Cen­ter for Trans­la­tional Ge­nomics and Health Out­comes. “If you over-reg­u­late, you run the risk of sti­fling in­no­va­tion in a very dy­namic in­dus­try.”

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