23andMe遇到麻烦了 被FDA禁止销售其基因检测试剂盒

科技带来进步也带来问题，如果恰跟食物或放医疗有关的话，也会让 FDA 闲不住。此前 FDA 勒令初创公司 23andMe 于 11 月 22 日之前停止售卖其基因检测装置（试剂盒），甚至还写了一封信说，既然 23andMe 提供的是医疗设备，那么在上市之前就要接受 FDA 的监管。

人们使用 DNA 检测装置主要是为了检测重大疾病的发生机率，想要使用 23andMe 服务的人只要向其邮寄一份自己的唾液样本就可以了，不过人们真地按照检测结果行事也是有风险的，万一检测失误，人们由于恐惧将来会得乳癌就做了乳房切除手术，人们的健康损失、谁来担此责任都成了不得不考量的问题。

目前， 23andMe 已经积累了40万个人用户的DNA数据，这对基因研究人员来说是一笔宝贵的信息。23andMe 目前已拿到 1.61 亿投资，其中Google、Milner 、NEA等都是其投资方。

之前 23andMe 就向 FDA 提交过批准 DNA 检测装置的申请，但被 FDA 否了。23andMe 的服务很可能会伤到保险公司的既得利益，如果人们都通过基因检测来预知自己身体状况，或者根据检测数据诊断出可能得病的人都去上保险了，保险公司是有理由担忧的。（转化医学网360zhyx.com）


英文原文：

---

DNA Testing Startup 23andMe Hits A Snag As FDA Shuts Down Sales Of Home Testing Kit


The U.S. Food and Drug Administration has ordered 23andMe, the genomic startup co-founded by Anne Wojcicki, Linda Avey and Paul Cusenza in 2006, to stop selling its at-home DNA testing kits as of November 22. As Bloomberg reports, a letter from the FDA sent to the company made public today classifies the kit as a medical device and outlines that it required regulatory approval before being sold.

Part of 23andMe’s mission is to help people assess their risk and the risk of their offspring for genetic, inheritable diseases and conditions, and that’s what the FDA has apparently taken issue with. Determining medical risk classifies the kit as a medical device, the organization says, even if that’s not the sole use 23andMe’s service (many get tested simply out of curiosity, or to help support ongoing research initiatives). 23andMe’s database of 400,000 total individuals is a veritable treasure trove of info for genetic researchers. Still, if a patient receives a prognosis that indicates they’re likely to develop breast cancer, and gets a double mastectomy as a preventative measure, only to have that turn out to be a false positive, that’s a big risk and justified cause for scrutiny.

23andMe has investment from Google, which first contributed to a $3.9 million into the company in a Series A round in 2007, and most recently the company raised $50 million in a Series D round that included Google, NEA, Milner and more. The self-testing service, which simply requires a customer to provide a saliva sample via mail, also won TIME magazine’s “Invention of the Year” award back in 2008. The startup has faced regulatory hurdles before, including from New York and California state organizations attempting to block the tests on licensing grounds, but 23andMe later secured licensing to continue to operate.

23andMe has previously submitted applications to the FDA in an attempt to get their devices approved, but the FDA said those failed to address issues that have come up before between it and the company. There’s also the spectre of vested interests looming over this case, however: The biggest U.S. health insurer in operation raised a stink about 23andMe’s tests back in 2012. 23andMe has identified a massive, lucrative market opportunity and there’s good reason for insurers and others to want a say in how the money shakes out.

We’ve reached out to 23andMe for comment, and will update this story should they provide more information.

Update – 23andMe provided the following statement:

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

来源：36kr