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Holidays will look different this year for many Americans, with dinners outside, social distancing, or passing on family gatherings altogether. But several companies developing rapid at-home COVID-19 tests are hopeful that won't be the case next year. The goal is to make inexpensive, easy-to-use COVID tests that can deliver results in minutes, just like a pregnancy test. "For people to feel comfortable to associate with friends or family, there needs to be a testing methodology ideally that can be performed at home," said Tony Lemmo, CEO of the manufacturing company BioDot.The company's technology is being used by over 70 manufacturers worldwide making COVID-19 antigen, antibody, and PCR tests. Their automated platforms dispense nanoliter/picoliter amounts of reagent onto the tests accurately and fast.Lemmo says just one of their systems can support the production of roughly 100 million COVID-19 tests per year, helping to make high-volume production possible.“We knew we were going to be called on by customers to manufacture more equipment to provide them the ability to manufacture more tests," said Lemmo. To meet customer demand, BioDot increased staffing and built a new facility, compressing production time from months to weeks. The FDA recently authorized the first rapid at-home test that can deliver results in 30 minutes, eliminating the need for a lab to test the sample. But the molecular single-use test will only be available to patients with a doctor's prescription who are suspected of being infected with COVID-19.Companies developing tests hope the FDA will soon authorize another at-home testing tool: the rapid antigen test.These inexpensive tests provide results within minutes, and companies developing them say millions could be sold without a doctor's referral.“From what we’re hearing, it’s really just a matter of possibly months before there’s at least sufficient data to be able to support an at-home use of a test like an antigen test," said Lemmo.Lemmo says if authorized by the FDA, manufacturers could make millions of these tests in a matter of months. But antigen tests are less accurate, and the FDA wants to ensure they'll be simple enough for people to use at home. There are also concerns over how the data will be reported to health authorities. “I think any at-home testing or massive rollout of a test into the communities needs to be done very carefully and with a lot of education around it," said Clinical Lab Director Melissa Miller. Dr. Miller is a professor of pathology and laboratory medicine at the University of North Carolina Chapel Hill and Medical Director for the Clinical Microbiology Lab for the Medical Center.She worries the inaccuracies of these tests could eventually lead the public to lose trust in all testing. “Even at 98 percent specificity, which is very, very high. That means you’re going to have a false positive two out of every 100. If you started testing a hundred million people, this is millions of people who have a false-positive test," said Dr. Miller. She says this could lead to healthy people isolating and missing work or school unnecessarily, and false-negative results could give people a false sense of security. “These rapid antigen tests were pushed out to skilled nursing facilities; this is a very high-risk patient population. This is actually where you want a very accurate test," said Dr. Miller. She says it’s unclear how well antigen tests detect the virus in asymptomatic patients but agrees more data is needed to figure that out.“It might make more sense for K-12 schools, or even college settings, where there’s less risk for a poor outcome if you have a false positive or a false negative," said Dr. Miller. But with a growing demand for convenient at-home testing, manufacturers are hopeful that in the months ahead, the FDA will soon open the door to new solutions. 3889
HBO announced Wednesday its new streaming service, which launched earlier this year, will be carried on Roku and PlayStation 5.HBO says that the app is now available on the PlayStation 5. Roku users should be able to find the app starting tomorrow.HBO Max is one of many new streaming platforms that have launched in recent years in the wake of Netflix’s massive success. Other services such as Disney+, Peacock, Prime Video and entered the fray. In addition to HBO Max’s library of HBO TV programs, the platform has plucked shows from other networks, most notably “Friends.”“We believe that all entertainment will be streamed and we are thrilled to partner with HBO Max to bring their incredible library of iconic entertainment brands and blockbuster slate of direct to streaming theatrical releases to the Roku households with more than 100 million people that have made Roku the No. 1 TV streaming platform in America,” said Scott Rosenberg, Senior Vice President, Platform Business, Roku. “Reaching mutually beneficial agreements where Roku grows together with our partners is how we deliver an exceptional user experience at an incredible value for consumers and we are excited by the opportunity to deepen our longstanding relationship with the team at WarnerMedia.” 1280
Hillary Clinton said Tuesday that President Donald Trump staged a "political rally" at Supreme Court Justice Brett Kavanaugh's ceremonial swearing-in that "further undermined the image and integrity of the court.""What was done last night in the White House was a political rally. It further undermined the image and integrity of the court," Clinton, Trump's Democratic 2016 election opponent, told CNN's Christiane Amanpour in an exclusive interview."And that troubles me greatly. It saddens me. Because our judicial system has been viewed as one of the main pillars of our constitutional government. So I don't know how people are going to react to it. I think, given our divides, it will pretty much fall predictably between those who are for and those who are against," Clinton said. 795
Heather Locklear has pleaded not guilty to charges related to an alleged domestic dispute, according to the Ventura County, California, district attorney's office.The actress was not in court Thursday for the plea, which her attorney entered on her behalf.Locklear is charged with five misdemeanor counts: four counts of battery on a peace officer and one count of resisting, obstructing or delaying a peace officer.Police were called to Locklear's home in Thousand Oaks, California, in February regarding a domestic incident between the actress and her boyfriend.Authorities declined to identify Locklear's boyfriend.The former "Melrose Place" star, 56, was taken into custody. Ventura County sheriff's deputies said at the time that Locklear was "extremely uncooperative and physically combative."Locklear was released on ,000 bail.The actress has not commented on the incident.A pretrial conference is set for June 7. 937
Here in the U.S., states are handling vaccine distribution in different ways.Most are going with health care workers in direct contact with COVID-19 patients first, but plans could change.“So, we need to set realistic expectations that there will be guidance that's different in different states. The guidance will evolve as we get more and more vaccines. And that doesn't mean anything's wrong or we've changed our minds, it’s just the way it's going to roll out,” said Stacy Hall, Director of Louisiana’s Public Health Immunization Program.Louisiana plans to let its hospitals and EMS distribute the first doses to their staffs. It’s a strategy not just to protect the valuable workers, but to hopefully get the public on board.“I'm really eager for them as the first group to really learn the science about the vaccine and step up and be vaccinated. I think that'll set our whole campaign in Louisiana and nationally on the right track,” said Hall.As for the cold storage of the vaccine, Louisiana doesn't see it as overly challenging.They also plan to use the state immunization information system to track who needs second doses and where the vaccine is being used most.“I want us to keep going back to that. There will be challenges and issues, but what a wonderful opportunity to make a change in the trajectory of the pandemic,” said Hall.The reality is, it will be months before the general public will get the vaccine at a pharmacy or drive thru. 1464