FDA Approves Direct-to-Consumer Cancer Mutation Test

23andMe image

According to the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more.

Black Mirror Renewed For Season 5 At Netflix
The snippet showed a montage of clips of Black Mirror's previous episodes, ending with a cliffhanger phrase "Be Right Back". In 2015, when Netflix purchased the series, it ordered 12 episodes which were split into two seasons of six episodes each.

A view shows the U.S. Food and Drug Administration headquarters in Silver Spring Thomson Reuters (Reuters) - The U.S. Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene. "But it has a lot of caveats", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

"I don't want to trivialize the potential for serious psychological burden that this risk information might provide; however, it is risk information that we know can lead to life saving interventions", Green said. Currently, pretty much all BRCA1 and BRCA2 screenings are called for by a doctor, for patients already identified as either having cancer, or as having a high risk of cancer. "While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test". For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. Test results come in the form of a report sent to the user. The evaluation, through the FDA's pathway for novel, moderate-risk medical devices, required greater than 99 percent accuracy and repeatability for the assay to be approved. The agency also outlined special controls created to assure test's accuracy and reliability.

Anthony Davis exits vs. Clippers with rib injury
Okafor back: Pelicans center Emeka Okafor back in the lineup after missing Sunday's win over Dallas with a sprained ankle. With this, the Pelicans have won their ninth straight contest, their longest winning streak since the 2010-11 season.

The FDA granted the marketing authorization to 23andMe.

Prosecutors seek at least 15 years prison for 'Pharma Bro' Martin Shkreli
The amount of loss plays a major role in determining how much prison time is recommended by the federal guidelines. Shkreli faces a maximum of 20 years in jail - which could boil down to just 12 to 18 months and community service.

Related News:

  • Authorities searching for man seen severely beating man carrying daughter

    Authorities searching for man seen severely beating man carrying daughter

    After that, the men continue beating Brown-kicking him and kneeing him in the face in addition to the punches. Jefferson County Sheriff's deputies want to find a man who fought another man who was holding a child.
    Athletics: IAAF extends Russia's ban, warns of new sanctions

    Athletics: IAAF extends Russia's ban, warns of new sanctions

    When asked if it had damaged his reputation, as stated in the... "It is in nobody's interest to be sitting here in no man's land". Russian Federation has been banned from the sport since November 2015 after the McLaren report discovered widespread doping.
    New Barbies honor NASA legend, inspiring women | GeekWire

    New Barbies honor NASA legend, inspiring women | GeekWire

    Barbie is marking International Women's Day , which is March 18, by honouring some of the inspiring women of the past and present. Katherine's doll is one of the first three to be released alongside the artist Frida Kahlo and legendary pilot Amelia Earhart .
  • Coinbase Announces Launch of Crypto Index Fund - Not Ripple Addition

    Coinbase Announces Launch of Crypto Index Fund - Not Ripple Addition

    The Coinbase Index Fund will give accredited US investors exposure to all assets listed on the company's current exchange, GDAX . The customers can invest on a monthly basis and withdraw every quarterly.
    Vettel fastest early as tests resume, McLaren struggles

    Vettel fastest early as tests resume, McLaren struggles

    Lance Stroll finished the session at the bottom of the time sheets after completing 86 laps in Williams in the afternoon. It's the right thing to do; we have found some that are not fit for objective and that's great".
    Bumble Bans Gun Photos From Members' Profiles

    Bumble Bans Gun Photos From Members' Profiles

    Dating app Bumble has banned images of guns from users' pictures after the latest mass shooting rocked the country. Herd also got in a dig against Facebook and Twitter, saying she hopes her platform is being more "proactive".
  • Trump administration sues California over sanctuary laws

    Trump administration sues California over sanctuary laws

    The California laws at issue limit state and local police cooperation with federal immigration authorities in a variety of ways. Department of Justice says Sessions will speak Wednesday at an annual gathering of law enforcement officials in Sacramento.
    Leader projected to be next South Korean president quits after rape claims

    Leader projected to be next South Korean president quits after rape claims

    One of his secretaries told a television interviewer on Monday that Mr Ahn had raped her four times since hiring her in June. Ironically, the day Kim made his boss's vile behavior public, he had expressed support for the #MeToo movement.
    State of Decay 2 release date revealed, pre-orders open today

    State of Decay 2 release date revealed, pre-orders open today

    Though the Standard Edition releases on May 22, purchasing the Ultimate Edition will snag you early access to the game by May 18. Thankfully, the wait won't be for much longer, with a release now set for 22nd May on Xbox One and Windows 10.
  • 4th ODI match - Summary

    4th ODI match - Summary

    At 2-2, the Kiwis were in dire straits, but Taylor and Kane Williamson with 45 steadied the ship with an 84-run stand. But Santner was culpable when he put down an easier chance at extra-cover off Trent Boult to reprieve Bairstow on 74.
    Brokers Ratings on: The Coca-Cola Company (NYSE:KO)

    Brokers Ratings on: The Coca-Cola Company (NYSE:KO)

    The company reported $0.39 earnings per share (EPS) for the quarter, beating analysts' consensus estimates of $0.38 by $0.01. After this sale, 117,177 common shares of KO are directly owned by the insider, with total stake valued at $5,122,978.

    Syrian Democratic Forces Sending Fighters to Afrin to Help YPG Fight Turks

    Earlier, Turkish President Recep Tayyip Erdogan said that the time has come for the offensive towards the center of Syria's Afrin. The monitor says 300 pro-Ankara rebels and almost 320 Kurdish fighters have also lost their lives.


Most liked

Australia, Timor-Leste sign maritime border pact
Australia has pushed for 80 per cent of revenue to flow to the Timorese, but with the gas piped to Darwin for processing. In particular, our treaty reflects the importance of the United Nations convention on the law of the sea .

Diamondbacks will be first team in 22 years to use bullpen auto
The team brought two golf cars and put big Diamondback helmets on top. Over the years, the bullpen auto even caused political controversy.

Man disciplines son by making him run to school in rain
Mr Thornhill later uploaded another video of him running with his son and daughter, saying both kids wanted to run to school now. Another added: "I hope your child doesn't have problems with getting bullied after you posted this embarrassing video of him.

Mamata attributes Congress' Tripura defeat to failure in forging alliance
Senior TMC leader Derek O'Brian said Banejree has also reached out to Telangana chief minister K. The opposition is now joining hands outside the Parliament too.

Periyar's statue row: PIL filed against BJP's H Raja
Sathyaraj, who has always been vocal about Tamil pride posted a video through his son Sibi's Twitter handle. He should have said build hospitals before churches, instead he says build hospitals before temples.

U.S. intelligence chief warns of China spending to boost influence
The intelligence director echoed the concerns of Navy Admiral Michael Rogers, the outgoing chief of the NSA and U.S. Cyber Command, who told lawmakers last week that Russian Federation hadn't "paid a price" for election interference.

Dave Warner Stoush Reportedly Provoked By Alleged Comment About Warner's Wife
Early indications are that they could contest it, in which case a hearing would take place later on Wednesday (March 7). First, we saw how David Warner gave a send back to AB De Villiers when the stalwart batsman got run out.

Gonzaga pummels BYU, 74-54, to win sixth straight WCC tournament title
Johnathan Williams had 10 points and 10 rebounds for Gonzaga , which won its 13th straight, and 16th at the WCC Tournament. White released a pick on BYU +5.5 against Saint Mary's , suggesting the Cougars had a chance at the outright upset.

Sade Releases 'Flower of The Universe' From Disney's Future Soundtrack
In announcing the song last month , director Ava DuVernay tweeted , "I never thought she'd say yes, but asked anyway". Just to dial up the hype some, this is Sade's first release with her band in eight years.

Police involved in shooting situation in community of Clinton, Mo
There are multiple law enforcement agencies on scene, including the Missouri State Highway Patrol. Now, once again, Clinton officers will face the disgusting task of burying one of their own.

Campaign to cut calories
Dr Alison Tedstone, chief nutritionist at PHE, said: "It's hard for people to make healthy food choices. Duncan Selbie, chief executive of PHE, said: "Britain needs to go on a diet".

Ex-Trump Campaign Staffer Sam Nunberg Dared Robert Mueller to Arrest Him
Later that day however, Nunberg told The Associated Press that, in the end, he's likely "going to end up co-operating with them". Asked Tuesday about the concerns he elicited, Nunberg declined to get into details and said simply "it's not an issue".

Oprah on the inspiration for her "A Wrinkle in Time" character
Meg herself is played by 14-year-old Storm Reid , who made her debut in the Oscar-winning film Twelve Years A Slave . Calvin, Meg's newfound confidant, shrouds his superb intellect to fend off bullies who target brainy nerds.

Teams Likely To Land Deal With Kirk Cousins Now Down To Four
It is, however, interesting that the Vikings are seemingly prioritizing McCarron over Keenum should they fail to land Cousins. Cousins has been adamant about wanting to play for a contender and finally win a Super Bowl championship.

International Women's Day 2018: #PressforProgress
According to the World Economic Forum's Global Gender Gap Report , it will take 217 more years to close the gender parity gap. The first national women's day was held in NY in 1909 on February 28 and it was organized by the Socialist Party of America.