Direct-to-consumer cancer risk test gets FDA approval
08 March, 2018, 01:52 | Author: Lorraine Moran
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.
"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.
Women with one of these variants have a 45-85% chance of developing breast cancer by age 70.
"Some of the uses for which PGS is intended are particularly concerning", the FDA writes, "such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these". This week, the FDA approved the genetic test by the company, 23andMe, which is part of its $199 Health and Ancestry product.
It doesn't find all cancer-causing genes - not by a long shot, the FDA said.
Advanced GOES satellites to improve weather forecasting
It also tracked the paths of Hurricanes Irma and Maria , providing crucial data as to which areas would be impacted the greatest. This will extend the life of GOES-R constellation to 2036 as many more satellites will be launched in coming years.
The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.
"This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the ability of direct-to-consumer genetic tests".
The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries. 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.
The preemption clause in the FCC's net neutrality repeal means Washington state may face legal challenges to the new law . But Hansen believes that the FCC relinquished its authority over net neutrality rules by rescinding them nationally.
The bill to ban assault weapons, including the AR-15 used in the school shooting, failed by a 20-to-17 vote. For 15 minutes, the Florida Senate was in favor of a two-year moratorium on sales of assault weapons.
Newspaper Choson Sinbo claimed that Pyongyang had never begged for talks with Washington D.C., the Yonhap news agency reported. In November past year , Reuters quoted a White House official as saying, with a note of sarcasm, "He's such a dreamer".
Witnesses said five armed men got out of a vehicle and opened fire on passersby before heading toward the French embassy. Burkina Faso is among a number of vulnerable countries in the southern Sahara region that are fighting jihadist groups.
When Ortiz does manage to get inside of the champ's reach, he will hit and perhaps even hurt Wilder, but that shouldn't be often. The fight was canned, and now he had a valid excuse not to schedule another fight against him.
Kushner's company, which he left to take his position in the White House past year , is also being investigated by the U.S. His real estate holdings and other investments are worth as much as $761 million, according to government ethics filings.
Jared Kushner, Trump's son-in-law and Middle East adviser, attended some but not all of the lengthy session, Netanyahu said later. Israel is increasingly anxious that Trump is backsliding on a pledge to "fix" or dismantle the 2015 Iran nuclear deal.
In it, she rejected as "unacceptable" proposals from Brussels to keep customs union arrangements in Northern Ireland . The speech was as much about tone as it was about laying out Britain's negotiating position.
The Pittsburgh Steelers have met with the 2016 Heisman Trophy victor at the 2018 NFL Scouting Combine in Indianapolis . Long certainly isn't the only one who has questions about teams' analysis of Jackson's ability and potential.
After the cold start, temperatures will slowly rebound into the mid 40s under sunny skies, average for this time of year. The sun may try to peak out during the afternoon, especially north of I-44 where temperatures will be warmest.
Three to five inches of snow expected on the East End
The peak of the storm still appears to be from mid-afternoon, through the evening, into the early overnight hours. The mixing line could come farther north if the storm's track comes closer to CT , introducing more warm air.
German Chancellor Angela Merkel set to serve 4th term
Following the SPD's emphatic decision for a new partnership, Merkel is expected to launch her fourth government by mid-March. Party leaders say they expect a "yes" vote to the coalition deal they hammered out with Merkel and her allies.
Gazprom terminates all contracts with Ukraine immediately
Gazprom had said that the court rejected demands of Naftogaz to increase the tariff for gas transit from Russian Federation . The decision has violated the balance of interests of the parties under these contracts, the head of Gazprom said.
Israeli police grill Netanyahu in telecoms corruption case
Netanyahu is suspected of acting to benefit internet giant Bezeq, also owned by Elovitch, for favorable coverage on the news site. Public radio said on Friday that both were being questioned at fraud squad headquarters simultaneously with Sara but separately.