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Morning Briefing

Summaries of health policy coverage from major news organizations

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Monday, May 11 2020

Full Issue

First Antigen Test Gets Green Light From FDA: 'A Lot Of Us Have Been Looking Forward To This Moment'

Experts say the tests are quicker than the traditional kits that have been hampering the United States' efforts to quickly identify people who have been infected with COVID-19. In other tracking news: spit tests, privacy, shortages and more.

The Food and Drug Administration has approved the first antigen test that can rapidly detect whether a person has been infected by the coronavirus, a significant advancement that promises to greatly expand the nation鈥檚 testing capacity. The test, by the Quidel Corporation of San Diego, was given emergency use authorization late Friday by the F.D.A., according to a notice on the agency鈥檚 website. (Jacobs, 5/9)

State leaders across the U.S. moved to expand testing for the new coronavirus, while lifting some restrictions on travel and business that have crippled the nation鈥檚 economy. The moves come as confirmed infections topped 4 million across the world, and the U.S. death toll climbed above 78,000. New York Gov. Andrew Cuomo on Saturday announced the opening of 22 new sites meant to provide coronavirus testing for thousands of residents and enable epidemiologists to trace the disease鈥檚 spread. (Chapman, Yoon and Kostov, 5/9)

Antigen tests are a common screening tool that doctors use for other infections, such as influenza or strep throat, but this is the first antigen test specific to the coronavirus. It is conducted by a nasal swab and immediately tested in the doctor鈥檚 office or other point-of-care location, producing diagnostic results within minutes by quickly detecting proteins found on or within the virus. In a statement announcing the emergency authorization of Quidel Corp.鈥檚 kit, the FDA said that antigen tests are cheaper to produce, simpler to conduct and easier to implement at scale than the current testing apparatus, which has relied on polymerase chain reaction (PCR) tests that detect genetic material from the virus. (Mettler, 5/9)

San Diego-based Quidel, which specializes in tests for flu, strep and other infectious diseases, already has placed about 36,000 test-analyzer instruments around the U.S. in places like hospital labs, emergency departments and doctors鈥 offices. 鈥淲e are ramping up manufacturing to go from 200,000 tests next week (week of May 11) to more than a million a week within several weeks,鈥 said Douglas Bryant, Quidel鈥檚 chief executive. (Burton, 5/9)

The Food and Drug Administration said on Friday that it had granted emergency authorization for the first at-home saliva collection kit to test for the coronavirus. The test kit was developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. 鈥婻utgers received F.D.A. permission last month to collect saliva samples from patients at test sites but can now sell the collection kits for individuals to use at home. They must be ordered by a physician. (Kaplan and Singer, 5/8)

New York City鈥檚 Office of Chief Medical Examiner isn鈥檛 performing widespread postmortem Covid-19 tests on people who have died at home during the new coronavirus outbreak because of a national shortage of testing supplies, city officials say. Instead investigators from the office have mainly been determining whether home deaths are related to the virus through interviews with decedents鈥 families and, if available, medical records that could help inform an opinion, the officials say. If the investigators believe the virus played a role, then the deaths are labeled 鈥淐ovid-probable,鈥 the officials say. (Hawkins, 5/10)

As Daniel Farzannekou prepared to take an online exam late last month in his naval science elective at the University of California, Los Angeles, the software directed him to pick up his laptop and scan his room, his desk, his ID and his face. 鈥淩idiculous,鈥 Mr. Farzannekou, a 20-year-old history major, fumed. He grabbed a notepad from his girlfriend, scribbled a two-word profanity in black ink and pointedly held it up to the webcam. Then he uninstalled the digital proctor software and fired off an email to his professor. The monitoring system was like something out of 鈥渃ommunist Russia,鈥 he wrote, demanding a less Orwellian test. (Hubler, 5/10)

"Testing, testing, testing" has become the mantra of the fight against the coronavirus. Scientific experts all seem to agree the virus cannot be controlled without adequate testing. If you want to know why, think of Ali Maow Maalin. Maalin, a young cook in the small coastal village of Merca, Somalia, was the last person to catch naturally transmitted smallpox. (Shurkin, 5/10)

Sen. Lamar Alexander (R-Tenn.) on Sunday said a 鈥渂reakthrough鈥 in coronavirus testing will be necessary to increase worker and consumer confidence enough to repair the U.S. economy.鈥 [I]f you take a test, and you know that you don't have COVID-19, and you know that everybody around you took a test that same day, you're going to have enough confidence to go back to work and back to school,鈥 Alexander said on NBC鈥檚 鈥淢eet the Press.鈥 (Budryk, 5/10)

Bob Grewal recently began testing a new health-screening setup for workers at a Subway restaurant he owns in Los Angeles near the University of Southern California. When he stepped inside the employee food prep area, a fever-detection and facial recognition camera service, PopID, quickly identified him by name and gauged his temperature. Then a small tablet screen underneath the camera posted a message that cleared him to enter. (Singer, 5/11)

Coronavirus testing became available to the majority of Cambridge residents regardless of symptoms on Friday, according to city and health officials. The Cambridge Health Alliance began offering COVID-19 testing via a stand-alone testing center at the CHA East Cambridge Care Center on Gore Street. (Finucane and Berg, 5/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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