{"id":17517,"date":"2010-05-12T03:13:42","date_gmt":"2010-05-12T03:13:42","guid":{"rendered":"http:\/\/euvolution.com\/futurist-transhuman-news-blog\/23andme-now-diagnoses-fatal-tay-sachs-disease\/"},"modified":"2010-05-12T03:13:42","modified_gmt":"2010-05-12T03:13:42","slug":"23andme-now-diagnoses-fatal-tay-sachs-disease","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/human-genetics\/23andme-now-diagnoses-fatal-tay-sachs-disease.php","title":{"rendered":"23andMe Now Diagnoses Fatal Tay-Sachs Disease"},"content":{"rendered":"

Exhibit: Patient: Andrew Yates “Tay-Sachs Disease | 23andMe Established Research Report” (negative\/negative)<\/a><\/p>

A deleterious mutation of the HEXA gene is by definition a diagnosis of Tay-Sachs<\/a> disease (homozygous or compound heterozygous) or Tay-Sachs carrier (heterozygous).<\/p>

Regarding 23andMe’s medical laboratory test commercially advertised by 23andMe to the public as “Tay-Sachs Disease | 23andMe Established Research Report”, (“Report”) 23andMe publishes the following Claim:<\/p>

Intended for research and educational purposes. Not for diagnostic use.<\/p><\/blockquote>

My complaint, as a human subject of this Report, is that 23andMe provides no distinction —other than the Claim itself— to justify why this Report is not for diagnostic use when the contents of the Report itself are sufficient for diagnostic use by the definition of a diagnosis of Tay-Sachs disease and of Tay-Sachs carrier status.<\/p>

Thus, I claim that the negligence of 23andMe to justify its Claim endangers my safety as I myself am unable to reconcile this apparent contradiction without this distinguishing information which 23andMe withholds from me and thus I am unable to best act to protect my health and the health of my potential children.<\/p>

===<\/p>

They are making medical claims. We don’t know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test.<\/p><\/blockquote>

Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, 2010<\/a><\/p>

Indeed.<\/p>

<\/a> <\/a><\/div>

<\/p>","protected":false},"excerpt":{"rendered":"

Exhibit: Patient: Andrew Yates “Tay-Sachs Disease | 23andMe Established Research Report” (negative\/negative)A deleterious mutation of the HEXA gene is by definition a diagnosis of Tay-Sachs disease (homozygous or compound heterozygous) or Tay-Sachs carrier (heterozygous).Regarding 23andMe’s medical laboratory test commercially advertised … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[4],"tags":[],"class_list":["post-17517","post","type-post","status-publish","format-standard","hentry","category-human-genetics"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/17517"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=17517"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/17517\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=17517"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=17517"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=17517"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}