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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

Hank Azaria says his "eyes have been opened" and he's willing to "step aside" from playing his controversial "Simpsons" character.The actor appeared on Tuesday's episode of "The Late Show with Stephen Colbert" and talked about the fallout surrounding the character he voices, Apu Nahasapeemapetilon.Comedian Hari Kondabolu's documentary "The Problem with Apu" debuted last November and looked at the character as a negative, stereotypical representation of South Asians.Nahasapeemapetilon, a Indian-American character with a thick accent, operates the Kwik-E-Mart convenience store in the fictional town of Springfield. The show recently aired a response to complaints about him.Writers had the character of Lisa Simpson respond to a question from her mother Marge by saying, "Something that started decades ago and was applauded and inoffensive is now politically incorrect. What can you do?" before Lisa glanced at a framed photograph of Apu on her nightstand, which was inscribed with the message "Don't have a cow."The scene generated further complaints from viewers.Azaria voices multiple characters on the show, including Moe Szyslak and Chief Wiggum. He told Colbert he just wanted to be funny."The idea that anybody, young or old, past or present was bullied or teased based on the character of Apu, it just really makes me sad," Azaria said. "It was certainly not my intention. I wanted to spread laughter and joy with this character and the idea that it's brought pain and suffering in any way, that it was used to marginalize people, it's upsetting."The actor told Colbert he had nothing to do with the show's response, given that Apu doesn't speak during the episode. Azaria said he did not agree with the show's response to the controversy.Azaria said he's given a great deal of thought to how to proceed and believes "the most important thing is to listen to South Asian people, Indian people in this country when they talk about what they feel and how they think about this character."He also called for more inclusion in "The Simpson's" writing room -- even if that means he no longer voices Apu."I really want to see Indian, South Asian writer, writers in the room, not in a token way but genuinely informing whatever new direction this character may take, including how it is voiced or not voiced," Azaria said. "I'm perfectly willing and happy to step aside or help transition it into something new. I really hope that's what 'The Simpsons' does and it not only makes sense, but it just feels like the right thing to do to me."CNN has reached out to "The Simpsons" for comment. 2604

HAMPTON ROADS, Va. - A Virginia company is unveiling a brand new technology, with help from jellyfish, to help in the fight against COVID-19.“We're just pretty motivated by the fact that we're making an impact to open the economy, places back up safely,” Senseware CEO Dr. Serene Al-Momen told News 3.Senseware, a technology company based in northern Virginia, specializes in air monitoring.“We quickly realized that the primary concerns of transmissions are airborne transmission for the COVID-19 virus,” Al-Momen said.The technology the company is rolling out is a new pathogen-detecting monitoring system using specific antibodies and proteins from jellyfish that light up when coming in contact with COVID-19.“We're talking about having the results available within minutes, under five minutes,” she said. “If the virus is detected, we immediately in real-time with our cloud-based technology alert you. You see the threat, the detection on your phone. You get an email if you're an operator. You're able to quickly mitigate that issue.”Al-Momen told News 3 the product is in the final stages of third-party testing. She added they’re also looking throughout Virginia, including Hampton Roads, for beta testing sites, specifically healthcare and treatment centers.“This is creating a way to create a safer environment and begin to create that confidence in people to re-populate spaces,” she said.She said it's all about keeping people safe and giving them peace of mind.“Knowledge is power,” Al-Momen said. “When you're having that real-time, around the clock, monitoring of all aspects of air quality, it will create that confidence for people to know that there's that data available in real-time.”This story was first reported by Zak Dahlheimer at WTKR in Norfolk, Virginia. 1790

HAVRE, Mont. (AP) — U.S. Customs and Border Protection officials are reviewing an encounter between a Border Patrol agent and two women who were speaking Spanish at a gas station in northern Montana, the agency said Monday.The women, who are U.S. citizens, said the agent detained them for about 35 minutes Wednesday in Havre, a small city about 30 miles from the U.S.-Canada border. One of the women, Ana Suda, asked the agent why he asked for their identifications."I recorded him admitting that he just stop(ped) us because we (were) speaking Spanish, no other reason," Suda wrote in a Facebook post published early Wednesday. "Remember do NOT speak Spanish sounds like is illegal."Neither Suda nor her friend, Mimi Hernandez, answered their cellphones or responded to text messages on Monday. In Suda's video of the encounter, posted by KRTV of Great Falls, the agent says speaking Spanish "is very unheard of up here."Customs and Border Protection spokesman Jason Givens declined to answer questions about the incident. He released a statement that said the incident is being reviewed to ensure that all appropriate policies were followed."Although most Border Patrol work is conducted in the immediate border area, agents have broad law enforcement authorities and are not limited to a specific geography within the United States," the statement said. "They have the authority to question individuals, make arrests, and take and consider evidence."Border Patrol agents are authorized by law to make warrantless stops within a "reasonable distance" from the border — defined as 100 miles (160 kilometers) under federal regulations. That broad authority has led to complaints of racial profiling by agents who board buses and trains and stop people at highway checkpoints.Havre, which has just under 10,000 residents and is near two Native American reservations, has a mostly white population, with just 4 percent Hispanic, according to the U.S. Census.It is typically a quiet posting for the Border Patrol. Last year, the 183 agents in the Havre sector made 39 arrests — just .01 percent of the 310,531 arrests made nationwide made by Border Patrol agents. Eleven of those 39 people arrested were Mexican.Last week's confrontation happened within a day of the posting of another video showing a New York attorney ranting against Spanish speaking restaurant workers and threatening to call Immigration and Customs Enforcement to have them "kicked out of my country."Allegations have been made before of law-enforcement officers in Montana racially profiling people to find out their immigration status. In 2015, the Montana Highway Patrol established a policy forbidding the detention of a person based to verify his status, settling a lawsuit alleging that troopers routinely pulled over people for minor infractions to do just that. 2856

HAMPTON ROADS, Va. - As coronavirus continues to rage across the country, scientists are inching closer to developing a COVID-19 vaccine.Dr. Doug Mitchell used to be a pediatric infectious diseases specialist at CHKD and EVMS. He is currently the medical director of CHKD Medical Group and a pediatrician at Norfolk Pediatrics.“If we’re able to stick to the science in developing the vaccine, then that would be comforting if we could stick to the science and develop an effective and safe vaccine,” said Mitchell.Mitchell said the speed at which researchers are developing a vaccine to combat COVID-19 is nothing short of a miracle, but sticking to the clinical science behind the advancement is key for an effective and safe vaccine - and that takes time.“The stated goal that I saw by the CDC and/or FDA of wanting a vaccine that shows at least 50% protection and six months of safety data, that takes time,” he said. “We need a chance to show the safety profile of any new vaccine under the parameters of following the best science that we could follow.”Mitchell understands the process involved in developing a vaccine.More than 20 years ago, he was an investigator in several pediatric clinical trials. Many of the vaccines that came out of his lab are still used in children today.While there are still growing concerns about vaccines, the benefits outweigh the risks.“The flu vaccine clearly saves lives, clearly prevents illnesses, but it’s not 100% protective either, but we know it does have benefits,” Mitchell said. “The advantage there is the flu vaccine has been out for decades and we know its safety profile.”Similar to the rapid speed of developing a COVID-19 vaccine, Mitchell said a vaccine for H1N1, better known as the swine flu, was quickly put on the market.“The difference is, we already had decades of history of flu vaccines and their safety, so all that happened was developing the same flu vaccine that was protective against a different strain,” he said. “That’s a different ballgame than starting a vaccine against a totally different virus.”While the research continues, the fight against COVID-19 is far from over.According to Mitchell, the spread of the virus decreases when you reach heard immunity where enough of the population is immune.This story was first reported by Antoinette DelBel at WTKR in Norfolk, Virginia. 2363