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WASHINGTON, D.C. — A home test for COVID-19 will soon be on U.S. store shelves.The U.S. Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first kit that consumers can buy without a prescription to test themselves entirely at home.Regulators granted use for a similar home test last month, but it requires a doctor’s prescription.The new test kit from Australian company Ellume allows users to swab themselves and get the results at home in about 20 minutes.The test detects fragments of proteins of the coronavirus from a nasal swab sample from anyone 2 years old and up. It connect to a digital app to help users interpret the results.Similar to other antigen tests, the FDA says a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible.Individuals with positive results should self-isolate and seek additional care from their health care provider. Those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from coronavirus infection.The company says it will have 3 million tests available next month.“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. 1773

WASHINGTON, D.C. – President Donald Trump officially named Amy Coney Barrett as his Supreme Court nominee over the weekend.What we know about herBarrett has long been rumored to be a possible Supreme Court justice and before being nominated, she was believed to be the favorite among conservatives to take the seat vacated by the late Justice Ruth Bader Ginsburg.Barrett is currently serving on the 7th U.S. Circuit Court of Appeals and she spent several years as a professor at Notre Dame Law School, where she also earned her own law degree.Barrett is believed to be a true conservative, having formerly clerked for the late right-wing beacon Justice Antonin Scalia. If appointed to the high court, her rulings would likely be in line with her mentor. When accepting Trump’s nomination on Saturday, she said Scalia’s “judicial philosophy is mine, too.” Scalia helped popularize the idea of originalism, which follows the idea that courts should interpret the Constitution as it was originally intended by those who wrote it.In recent years, Barrett has sided with conservatives on cases involving immigration, guns rights and abortion.In a 2017 article, Barrett took issue with Chief Justice John Roberts’ ruling to keep the Affordable Care Act intact in 2012. Writing for the Norte Dame Law Journal, Barrett said “Chief Justice Roberts pushed the Affordable Care Act beyond its plausible meaning to save the statute."Barrett is also by legal standards young at only 48 years of age. Recently, both political parties have opted for younger justices to ensure they can serve for decades.Barrett and her husband, Jesse Barrett, a former federal prosecutor, have seven children, including two adopted from Haiti. They live in South Bend, Indiana, but the judge was born in New Orleans, Louisiana, where she was raised Catholic.If appointed to the Supreme Court, conservatives would hold a 6-3 majority over their liberal colleagues.Senate Republicans plan on swiftly moving forward with Barrett’s nomination, despite being weeks away from the general election.The confirmation process is sure to be a contentious one, with Democrats expected to highlight the possibility of the Affordable Care Act being dismantled and the fate of a woman’s right to choose in question.Watch Barrett accept the Supreme Court nomination: 2326

WASHINGTON (AP) — The Justice Department’s subpoena to Hunter Biden sought information involving more than two dozen entities to examine some of his foreign business ties, including with Ukrainian gas company Burisma. That's according to a person familiar with the matter who spoke to The Associated Press. The subpoena was issued this week as part of the Justice Department’s tax investigation of the president-elect’s son. It’s unclear what the significance is of the Burisma-related request — whether Biden’s work there is a central part of the investigation or whether prosecutors are simply seeking information about all the entities he has worked with in recent years.As part of the same investigation, prosecutors have also been scrutinizing some of his Chinese business dealings and other transactions. 818

WASHINGTON (AP) — With time running out, lawmakers are closing in on a proposed COVID-19 relief bill that would provide roughly 0 in extra federal weekly unemployment benefits but not another round of ,200 in direct payments to most Americans. That's an issue that President-elect Joe Biden will have to wrestle over with a new Congress next year. The 8 billion aid package to be released Monday would be attached to a larger year-end spending bill that's needed to avert a government shutdown this coming weekend. The ,200 cash payments were popular when they were first distributed after the pandemic hit, and Biden has expressed hope that a second wave might come after weekend negotiations. 712

WASHINGTON, D.C. – Dr. Deborah Birx is warning Americans who traveled for Thanksgiving and attended a large gathering that they should assume they were infected with the coronavirus.The coordinator of the White House Coronavirus Task Force is advising those who gathered with numerous loved ones for the holiday to get tested in next few days.“If your family traveled, you have to assume that you are exposed and you became infected and you really need to get tested in the next week and you need to avoid anyone in your family with comorbidities or (who is) over 65,” Birx told “Face the Nation” on Sunday.Birx also says the task force is even asking families to mask indoors if they chose to gather during Thanksgiving and others went across the country or even into the next state.“And if you're over 65 or you have comorbidities and you gathered at Thanksgiving, if you develop any symptoms, you need to be tested immediately because we know that our therapeutics work best, both our antivirals and our monoclonal antibodies, work best very early in disease,” said Birx.During her interview, Birx referred to the current spike in COVID-19 cases as the nation’s “third wave” and compared it to second wave we saw over the summer.“We saw what happened post Memorial Day,” said Birx. “Now we are deeply worried about what could happen post-Thanksgiving because the number of cases, 25,000 versus 180,000 a day, that's why we are deeply concerned.”Birx says she’s worried about how last week’s holiday gatherings may increase the case count even more, especially in states with fewer COVID-19 restrictions. If you live in one of those states, she says you should take it upon yourself to be restrictive.Watch Birx's "Face the Nation" interview below:In step with Birx, Fauci provided similar warnings during an appearance on “Meet the Press” on Sunday. He said the heavy holiday travel could make the current surge in COVID-19 cases even worse as we head into the winter months."What we expect, unfortunately, as we go for the next couple of weeks into December is that we might see a surge superimposed on the surge we are already in," said Fauci.Unless something changes dramatically, Fauci predicts health officials will advise against travel for the end of the year holidays and New Year’s Eve, like they did for Thanksgiving.“We’re going to have to make decisions as a nation, state, city and family, that we’re in a very difficult time and we’re going to have to do the kinds of restrictions of things we would have liked to have done, particularly in this holiday season. Because we’re entering into what’s really a precarious situation, because we’re in the middle of a steep slope.”Watch Fauci's "Meet the Press" interview below: 2746

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