FDA批准23andMe家庭疾病基因测试,其中包含10种疾病

9 个月前
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周四,食品和药物管理局 (FDA)批准了家庭DNA测试,让人们来测量它们是否存在某些遗传疾病的风险。FDA允许家庭DNA测试公司23andMe直接出售10种疾病的基因测试,其中包括帕金森症,阿兹海默症(老年痴呆)和一些罕见的血液病。

FDA设备和放射健康中心的主任Jeffrey Shuren博士说:因为这些测试的批准,现在消费者可以直接获取某些遗传风险的信息。但是研究人员也表示,由于太多其他因素的影响,基本测试不可能会做到100%的准确度,这意味着即便检测到一些基因遗传,但是并不意味着他们最终会发展成为一种疾病。

其实,消费级基因检测公司23andMe的成长路途也颇为坎坷。2013年,美国FDA叫停了23andMe的个人DNA检测服务。历经两年的努力,2015年,23andMe获得了美国FDA的认证,面向大众的消费级基因检测不再是灰色地带,而今天更是获得了全新的进展。

23andMe在营销家庭方面的做法比较激进,只需要测试者提供唾液就可以对其进行基因分析。以下是获批的10种疾病,但是对于人们是否容易患癌的基因检测不包含在内:

Parkinson's disease

Late-onset Alzheimer's disease

Celiac disease, which causes the inability to digest gluten.

Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease. More than 100 different genetic variations of the gene have been identified and only some are linked with deficiency.

Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements.

Factor XI deficiency, a blood clotting disorder caused by certain mutations in a gene called F11.

Gaucher disease type 1, an organ and tissue disorder caused by mutations in the GBA gene.

Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition.

Hereditary hemochromatosis, an iron overload disorder caused by mutations in at least five different genes.

Hereditary thrombophilia, a blood clot disorder

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来源:  nbcnews
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