Sunday, 24 June, 2018

FDA gives nod to 23andMe for no-prescription breast cancer gene testing

23andMe image FDA OKs direct-to-consumer test for certain types of breast cancer mutations
Carol Daniels | 08 March, 2018, 01:40

The test will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women-as well as breast cancer in men-by analyzing DNA from a self-collected saliva sample.

Experts say the three genetic mutations found in the 23andMe test are most commonly found in Jewish people.

"There are other genes besides BRCA1 and BRCA2 for breast cancer, and there are lots of other mutations on BRCA1 and BRCA2 that aren't being tested". It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the United States, and could significantly raise the number of people aware of having the cancer-related mutations. "The variants may also be associated with an increased risk for certain other cancers".

The direct-to-consumer genetic testing company 23andMe has received federal approval to inform people of breast cancer risk linked to three gene mutations, making it the first company allowed to test for cancer risk without a prescription in the United States.

Cigarettes Present The Same Carcinogenic Chemicals As The Regular Cigarettes
Community education specialist for Shasta County's tobacco program Manuel Meza says they're well aware of the dangers of vaping. Levels of toxic organic compounds were up to three times higher on average in the e-cigarette users compared with the controls.

Another incident for Aldon Smith
Smith, who recently got engaged , is now being pursued by police, who would like to discuss the incident further. Smith was a standout at the University of Missouri, where he played two seasons before entering the NFL Draft.

Songs, heartfelt words fill the Rev. Billy Graham's funeral
Billy Graham's family says the casket was made with no upgrades, and only minor modifications to allow for easy transport. Still, loved ones said Graham saw himself as a humble preacher who would have been embarrassed by such fanfare.

Consumers and health care professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Those decisions should be based on confirmatory tests and genetic counselling.

According to a company statement, 1 in 40 people of Ashkenazi Jewish descent will carry one of these mutations, which for a woman confers a 45 percent to 85 percent chance of breast cancer arising by the time she reaches age 70. Furthermore, only a small percentage of Americans carry one of these 3 mutations. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood.

The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. They provide information on what the results might mean and where to get additional information. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.

Recommended

  • Iran nuclear deal's collapse would be a 'great loss' - UN watchdog chief

    Iran nuclear deal's collapse would be a 'great loss' - UN watchdog chief

    France's Foreign Minister Jean-Yves Le Drian arrived in Tehran early Monday for talks on the 2015 nuclear deal and Iran's role in the Syrian conflict.
    Michael B Jordan offers to replace fan's retainer

    Michael B Jordan offers to replace fan's retainer

    The 31-year-old Jordan felt slightly responsible for the incident so offered to help replace her retainers. So, she might've lost a retainer, but it seems this whole thing turned out pretty great in the end.
    Brian Ortega Knocks Out Frankie Edgar (UFC 222 Results)

    Brian Ortega Knocks Out Frankie Edgar (UFC 222 Results)

    Once she was back in striking range, Cyborg began landing right-handed bombs and Kunitskaya went down. Ortega now extends his unbeaten streak to 14, including six under the UFC banner.
  • We are all Sam Nunberg

    We are all Sam Nunberg

    Asked if he was concerned about being held in contempt for refusing to comply with a subpoena , Nunberg laughed off the idea. Mueller also could seek to charge Nunberg with obstruction of justice. "I was feeling sorry for that kid", Scarborough said.
    What to watch in Tuesday's Texas primary

    What to watch in Tuesday's Texas primary

    Joe Kennedy III (D-Mass.), who is emerging as an important national leader with a political future that knows no limits. For the first time in a quarter of a century in Texas, there's a Democrat running for all 36 congressional seats.
    World's oldest message in a bottle found on Australia beach

    World's oldest message in a bottle found on Australia beach

    To think that this bottle has not been touched for almost 132 years and is in flawless condition, despite the elements. However, as provided on the website, there appears to be mentions of the name Paula in reference to the boat.
  • Illinoisans on Forbes list of world's billionaires

    Illinoisans on Forbes list of world's billionaires

    You got your Bezos, Buffett, Bloomberg, and Brin, as well as the Koch Brothers, Bill Gates , Larry Ellison , and Mark Zuckerberg . Forbes says Mr Bezos has seen his fortune climb to more than $112bn in the a year ago , but Donald Trump's wealth has decreased.
    Opioid overdoses kill nearly  5 people every hour in the US — CDC

    Opioid overdoses kill nearly 5 people every hour in the US — CDC

    But Delaware, Illinois, Pennsylvania and Wisconsin all saw increases of 50 percent or more in opioid overdose emergency visits. Nearly 100 people are dying every day across America from opioid overdoses - more than auto crashes and shootings combined.
    Apple set to turn up audio ambition with high-end headphones

    Apple set to turn up audio ambition with high-end headphones

    On the contrary, the headphones are expected to follow the footsteps of AirPod and will feature a similar set of features as well. Sources say Apple could redesign the headphones again before launch or even scrap the project entirely.
  • The chance for rain and snow will return overnight

    The chance for rain and snow will return overnight

    Lows Thursday night will fall back into the upper 30s before we start warming up into the weekend. In fact, the meteorological department had issued as many as 39 alerts during the last 24 hours.
    Gujarat: Truck carrying wedding guests falls off bridge, 28 killed

    Gujarat: Truck carrying wedding guests falls off bridge, 28 killed

    The group from Aniyali village near Palitana was heading to Tatam village for the wedding, when the incident took place. He however, was travelling by a auto and the rest of the people boarded the truck.
    Vatican finance chief faces crucial hearing on abuse claims

    Vatican finance chief faces crucial hearing on abuse claims

    Apart from the first 25 minutes, most of Monday's hearing was closed to the public while the first accuser gave evidence. Even if she decides the evidence is not sufficient to proceed, public prosecutors can still move to take Pell to trial.

Will give special status to AP if voted to power: Rahul Gandhi Will give special status to AP if voted to power: Rahul Gandhi BJP-TDP alliance is on the rocks and TDP is leading the protest against the BJP-ruled Centre in the Parliament over the issue of Special Category Status .

Kentucky sees decrease in ER visits related to opioid overdoses Kentucky sees decrease in ER visits related to opioid overdoses This fast-moving epidemic affects all ages, genders and states and is still increasing across the USA , she said. Consistent with the program report, it indicates that the Midwest (70%) is the most burdened region.

U.S. sees security risk from Qualcomm deal U.S.  sees security risk from Qualcomm deal CFIUS can approve or propose changes to deals, but only the president can block a transaction on national security grounds. The company will complete a corporate restructure and be headquartered in the U.S.by May 6, 2018.

Nashville Mayor Pleads Guilty To Felony Theft, Admits Affair With Bodyguard Nashville Mayor Pleads Guilty To Felony Theft, Admits Affair With Bodyguard Forrest's overtime pay more than doubled from 2014-15 to the 2016-17 budget year, according to Metro Nashville Police records . Barry claimed at the time the affair was a personal matter that violated no laws or ethical standards, and refused to resign.

Missouri's Michael Porter Jr. will play Thursday in SEC tourney opener Missouri's Michael Porter Jr. will play Thursday in SEC tourney opener Martin said Porter, the No. 1 recruit in the country past year , will he able to help Missouri in a variety of ways. In the season opener against Iowa State , he only played two minutes before leaving the game with a back injury.

Attorney General Jeff Sessions to make 'major' Sanctuary City announcement in Sacramento Attorney General Jeff Sessions to make 'major' Sanctuary City announcement in Sacramento It says the law violates the federal Supremacy Clause by serving as an obstacle to federal immigration enforcement. Cities and states were also required to certify that they complied with a particular federal immigration law.

United States pledges $533 million in aid to Africa, criticises Chinese investment United States  pledges $533 million in aid to Africa, criticises Chinese investment Hruby, former managing director of the Whitaker Group, an Africa-focused corporate strategy and investment advisory firm.

Justice Department accuses California of interfering with immigration policies in new lawsuit Justice Department accuses California of interfering with immigration policies in new lawsuit The administration is arguing the laws are unconstitutional and said it may also sue other states that have similar laws. It allows ICE agents to interview immigrants at county jails, though not to hold permanent office space there.

Guardiola hails Man City: "Who could believe it?" Guardiola hails Man City: We have shown that - and if we don't reach that kind of level of performance in every match, it's because of our attitude".

Oscar Envelopes Featured Font Large Enough To See From Home Oscar Envelopes Featured Font Large Enough To See From Home Comediennes Haddish and Rudolph co-presented the awards for animated and live-action short films and they were hilarious. After last year's disastrous "La La Land"/"Moonlight" mixup, Warren Beatty and Faye Dunaway returned for a do-over.

Watch a hotel rip Trump's name off its sign Watch a hotel rip Trump's name off its sign Fintiklis played a Greek song on the hotel lobby piano Monday, which he had done throughout the dispute to mark certain victories. All of this led to a November vote where the hotel's owner's association chose to do away with the Trump name and management.

Call of Duty: Black Ops 4 Leaked by Retailer Call of Duty: Black Ops 4 Leaked by Retailer According to a recent report by Charlie Intel , Call of Duty: Black Ops 4 merchandise has started appearing in GameStop databases. Treyarch is next up in the three-studio rotation, and has worked on the Black Ops series for its last three Call of Duty titles.

Neymar leaves hospital after 'successful' surgery on injured foot Neymar leaves hospital after 'successful' surgery on injured foot During the first portion of his recovery and rehabilitation, Neymar will be accompanied by PSG physical therapist Rafael Martini . The Brazil forward sprained his right ankle and cracked his fifth metatarsal during last Sunday's Ligue 1 victory over Marseille.

US Embassy to Turkey closed for security reasons US Embassy to Turkey closed for security reasons Meanwhile, Deputy Prime Minister Bekir Bozdağ said that Turkey is the country most effectively fighting against Daesh. Two others were detained in Samsun by police acting on information they provided, the report said.

Trump says he 'may' attend Jerusalem embassy opening Trump says he 'may' attend Jerusalem embassy opening Trump also said his administration is working "very hard" on a peace deal, but acknowledged potential problems. Palestinian Authority Leader Mahmoud Abbas has said he will not accept a peace agreement brokered by Trump.