2013年12月4日水曜日

FDA 23andMe Stop Services

FDAが23andMeの検査キット販売を停止警告を出した。
 FDAは、個人向け遺伝子検査サービスを手掛ける「23andMe」に簡易検査
キットの販売を即時停止するよう警告した。がんなどの診断結果を誤った
り、利用者が誤解したりした場合、深刻な影響が生じると判断。
同社に警告書を送付した。

警告
・2009年7月からFDCAの遵守を要請。
・唾液を採取し、遺伝情報を解析する料金99ドルのサービスを対象。
・がんや糖尿病、心臓病など254種類の病気にかかる遺伝的リスクを判定
 するとしているが、FDAは「臨床的な検証データが提出されていない」
 と指摘。

23andme
Board of Directors
・2006年設立
・役員
 Anne Wojcicki 女性 最高責任者 共同創設者 Sergey Brinの妻
 Andy Page   男性 社長
 Esther Dyson 女性 役員
 Patrick Chung 男性 役員

FDAの販売中止命令を無視し、23andMeのHPに簡易検査キットの販売を継続、
販売中止を表示していない。

臨床的な検証データが十分でないため、偽陰性(偽陽性含む)の確率が高い
とのことで、FDAは販売自粛要請(?)をしたが、本格的に販売を始めたので
販売中止命令のようだ。
簡易検査キットには、「遺伝と思われる場合は、専門医の診断」をとの
記載もあるようだ。

FDAは、未発症な乳がんを摘出する整形手術が流行していることにも懸念が
あるようだ。

Patent Designed Baby


FDA Recalls: 23andme Must Stop Selling At-Home DNA Tests


FDA halts sales of popular DNA testing kit


---遺伝子検査サービス中止を=誤解・誤判定を懸念-米FDA
2013/11/27-12:56
http://www.jiji.com/jc/c?g=int_30&k=2013112700403

 【ワシントン時事】米食品医薬品局(FDA)は26日までに、個人向け遺伝子検査サービスを手掛ける「23アンドミー」(カリフォルニア州)に簡易検査キットの販売を即時停止するよう警告した。がんなどの診断結果を誤ったり、利用者が誤解したりした場合、深刻な影響が生じると判断。同社に22日付で警告書を送付した。
 警告対象は、唾液を採取し、遺伝情報を解析する料金99ドルのサービス。がんや糖尿病、心臓病など254種類の病気にかかる遺伝的リスクを判定するとしているが、FDAは「臨床的な検証データが提出されていない」と指摘した。


---Genetic Test Service 23andMe Ordered to Halt Marketing by FDA---
By Peter Loftus
Updated Nov. 25, 2013 9:40 p.m. ET
http://online.wsj.com/news/articles/SB10001424052702304281004579219893863966448

Regulators Cite Risk of False Results, Unnecessary Health Procedures

U.S. regulators ordered genetic-testing company 23andMe Inc. to stop marketing its $99 mail-order kit, citing the risk that false results could cause consumers to undergo unnecessary health procedures such as breast-cancer surgery.

The warning to the Google Inc. -backed company from the Food and Drug Administration follows a debate that has grown as hundreds of thousands of people have turned to direct-to-consumer genetic tests for clues about disease risk and ancestry. Proponents say people have a right to direct access to their genetic data. But some public-health experts worry about inaccurate results or the misuse of data outside of the guidance of doctors and genetic counselors.

In a letter to 23andMe Chief Executive Anne Wojcicki, the FDA said that the company doesn't have proper clearance to market the DNA testing kit, and that 23andMe hasn't sufficiently worked with the agency to secure such approval. The FDA said it hasn't heard from the company since May, and has learned that 23andMe started new marketing campaigns for the test, including television commercials.

Privately held 23andMe is one of the leaders of the consumer genetic-testing market. In promotional materials, the company says its saliva-based test identifies more than 240 genetic traits that could offer clues to an individual's health or risk of disease. The company counts the venture arms of Google and Johnson & Johnson among its investors. Google referred questions to 23andMe, and J&J declined to comment.

Ms. Wojcicki, who co-founded the firm in 2006, is married to Google co-founder Sergey Brin ; the couple no longer live together, AllThingsD reported in August.

The FDA said it could take more serious regulatory action, including product seizures, if 23andMe doesn't take adequate corrective steps in response to the FDA letter.

23andMe, based in Mountain View, Calif., issued a written statement Monday saying "we have not met the FDA's expectations regarding timeline and communication" for the company's regulatory submission seeking marketing authorization for its service. The company said it would work with the FDA to address its concerns. An outside company spokeswoman declined to comment further and said Ms. Wojcicki wasn't available for interviews. 23andMe has previously said it has strengthened its quality-control systems to ensure accuracy of test results, and it educates its customers about the significance of the test results, encouraging them to discuss the results with doctors and genetic counselors.

The majority of genomic testing is still carried out in academic research labs, but tests aimed at consumers have multiplied in recent years.

Some geneticists and consumer advocates say the consumer-targeted tests have played a positive role in helping raise public awareness about genetics. A group of customers rallied to the support of 23andMe on the company's Facebook page on Monday; an online petition was started on WhiteHouse.gov, asking the Obama administration to overrule the FDA's action.

But others said they would welcome more regulatory oversight. David Goldstein, a professor of genetics at Duke University, said the tests weigh in on serious topics like whether a person carries genetic mutations that could cause disease in offspring. That sort of information can affect a person's decision about whom to marry or whether to have children, and can be dangerous if inaccurate, Dr. Goldstein said.

"It's more actionable information now. And we're all getting nervous. In that context I welcome what the FDA has done," he said.

David Valle, director of the McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University, said any companies wishing to sell genetic tests "should be willing to undergo scrutiny of their laboratory processes." He added that no consumer should be left on his or her own to interpret such "complicated and highly nuanced" data, and said a health-care professional should ideally be involved.

Consumers can order 23andMe's personal genome service online; once they receive a "spit kit," they provide a saliva sample and ship it back to 23andMe. The company says it uses technology provided by gene-sequencing company Illumina Inc. to analyze the genetic information that might make people predisposed to diseases including diabetes and breast cancer. The name 23andMe is a reference to human DNA being organized into 23 pairs of chromosomes. The company says it has more than 475,000 genotyped customers.

23andMe started its first national TV advertising campaign in the summer, including one spot featuring people next to graphical representations of their genetic profiles, saying "This part makes my eyes blue," and "I might have an increased risk of heart disease."

The FDA said in its warning letter it is concerned about some of the intended uses for the 23andMe test, including detecting mutations in so-called BRCA genes that can signal increased risk for breast cancer. The FDA is concerned that the 23andMe test could produce a false positive for such mutations, which "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening," while a false negative could miss an actual risk for the disease.

The FDA also cited concerns about false results from the 23andMe test's screens aimed at predicting patient response to certain drugs such as the blood thinner warfarin. Patients could have serious blood clots or bleeding if they took an incorrect dose of warfarin based on the 23andMe test results, the FDA said.

An FDA spokeswoman said the agency "needs to review genetic tests sold directly to consumers to make sure they are safe and do what they claim to do." She said the agency issued its warning letter "after the company has repeatedly failed to address specific concerns outlined by the agency since July 2009." 23andMe failed to submit information requested by the FDA, "putting consumers at risk of receiving inaccurate information that could result in delayed or inappropriate medical care," said the FDA spokeswoman.

The FDA has previously expressed concerns about the emerging field of direct-to-consumer genetic tests. In 2010, agency officials said they considered the tests "high risk," and told 23andMe and other companies that it considered their tests to be medical devices requiring FDA approval.

23andMe has defended its test, saying people have a right to their personal genetic data. The company says the genetic data complements family history in helping people to make informed decisions with their health-care providers.

The company applied for FDA clearance to market its test kit for several purposes in 2012. In January 2013, the company told the FDA it was conducting additional work on its application, including studies that would take several months to complete.

But the FDA said in its letter that 23andMe hadn't started certain studies that would be necessary to support a marketing submission.

The FDA said it now considers 23andMe's marketing application to be withdrawn. The company has 15 working days to respond to the FDA letter outlining specific actions it has taken to address FDA concerns.

Colleen Heisey, a Jones Day attorney focusing on food and drug law, said it appeared the FDA used its regulatory discretion to allow 23andMe to continue selling the product the past several years while the agency worked with the company on marketing authorization.

The new FDA warning letter "shows there's an end to that patience," said Ms. Heisey.

-Jeanne Whalen and Rolfe Winkler contributed to this article.


---FDA orders genetics company 23andMe to cease marketing of screening service---
Amanda Holpuch in New York
theguardian.com, Monday 25 November 2013 18.56 GMT
http://www.theguardian.com/science/2013/nov/25/genetics-23andme-fda-marketing-pgs-screening

Agency is 'concerned about the public health consequences of inaccurate results from the PGS device'


The US Food and Drug Administration (FDA) has ordered 23andMe to “immediately discontinue” the marketing of a genetic screening service, after the company failed to send the agency information that supports its marketing claims.

Alberto Gutierrez, director of the FDA’s Center for Devices and Radiological Health, said in a letter to the company made public on Monday that 23andMe had failed to address concerns raised on multiple occasions since the agency began working with it on compliance in July 2009.

23andMe’s $99 Saliva Collection Kit and Personal Genome Service (PGS) claims to test saliva, to provide data that shows users how their genetics may impact their health and explores their personal ancestry. The company is backed by Google.

“FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work,” Gutierrez wrote in the letter, which was dated 22 November and addressed to 23andMe co-founder Anne Wojcicki.

23andMe confirmed it had received the FDA's warning letter. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," the company said in a statement. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

The PGS service falls under the FD&C Act, which is used to regulate products that are intended to diagnose, mitigate, treat or prevent disease or to affect the structure of function of the body. The FDA said some of the intended uses of PGS were “particularly concerning”, because of the potential health risks that could come from a false positive or false negative.

“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment,” Gutierrez wrote.

The FDA said that while 23andMe had initiated new marketing campaigns that show how it plans to expand the uses of PGS, it had failed to provide information that the FDA requested multiple times. The FDA said it has had “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” with 23andMe to discuss how to get the company to comply with its recommendations.

“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” Gutierrez wrote.

23andMe is one of many companies to offer at-home genetic testing; in September it reported that its database had reached 400,000 people. Scientists have raised questions about the accuracy of the tests, and in May 2011 a Dutch study claimed the tests were inaccurate and offered little to no benefit to consumers.

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