May 11, 2020

Covid-19 roundup: FDA grants EUA for first at-home saliva test kit for new coronavirus

Daily Briefing

    FDA issues new guidelines for at-home Covid-19 diagnostic tests, Ford and 3M begin distributing respirators to providers, and more.

    Covid-19 weekly webinar: What health care leaders need to know

    • An observational study published Thursday in the New England Journal of Medicine found that hydroxychloroquine did not decrease the risk of death nor decrease the need for a ventilator among nearly 1,400 patients with Covid-19, the disease caused by the new coronavirus, who were treated at Columbia University in New York. Among 811 patients who were treated with hydroxychloroquine, 32.3% had to be placed on a ventilator or died, compared with 14.9% among the 565 patients who were not treated with the drug. The researchers noted that the study has limitations because it was observational and not a randomized, controlled trial. As such, they said their findings "should not be taken to rule out either benefit or harm" fromhydroxychloroquine (Emery, Reuters, 5/8; Marchinoe, Associated Press, 5/7; Hopkins, Wall Street Journal, 5/7).
    • Express Scripts has said it will offer discounted drug prices to Americans who recently became uninsured, as millions of Americans have lost their jobs amid the country's Covid-19 epidemic. The discounts will apply to a variety of drugs, including some medications intended to treat asthma, diabetes, glaucoma, heart disease, and migraines. Express Scripts said applicable generic drugs will be priced at $25 and applicable name-brand drugs will be priced at $75 for qualifying Americans (Humer, Reuters, 5/7).
    • FDA on Wednesday released new guidelines that will allow companies to develop and sell at-home diagnostic testing kits for the new coronavirus that people can use to collect their biologic samples for the tests themselves and send the specimens to labs throughout the United States to be analyzed. FDA said it hopes the new guidelines will increase the availability of diagnostic tests for the new coronavirus by encouraging manufacturers to produce at-home testing kits in mass quantities (Jacobs, New York Times, 5/7).
    • FDA also will begin requiring companies that make antibody tests for the new coronavirus, also called serology tests, to submit emergency use authorization applications that prove their products meet new standards for accuracy. FDA said the tests will need to be able to detect the new coronavirus at least 90% of the time or be able to avoid false positive results at least 95% of the time (Burton, Wall Street Journal, 5/4).
    • FDA on Thursday banned more than 65 of 80 previously authorized manufacturers of N95-style masks in China after tests conducted by CDC in April found that some of the companies' masks didn't meet certain quality standards. FDA said there are now just 14 mask manufacturers in China that are approved to make N95-style masks for use in the United States (Nicas/Kaplan, New York Times, 5/7; Hufford/Maremont, Wall Street Journal, 5/7).
    • FDA on Thursday issued its first-ever emergency use authorization for the gene-editing technology CRISPR, allowing Sherlock Biosciences to distribute a diagnostic test for the new coronavirus that Sherlock claims can determine whether a patient sample contains the virus within roughly an hour. According to Forbes, Sherlock currently is working to ramp up availability of the tests and is planning to make an announcement regarding access to the test in the coming weeks (Jennings, Forbes, 5/7).
    • FDA on Friday issued an emergency use authorization for the first at-home coronavirus testing that uses a person's saliva. Patients will be able to order the test kit—which was developed by Rutgers University's RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs—through their provider (Kaplan/Singer, New York Times, 5/8).
    • Ford Motor on Wednesday announced that it will start delivering battery-powered air-purifying respirators to health care providers nationwide. Ford has been working with 3M since late March to design and manufacture the personal protective equipment and so far has made more than 10,000 respirators at one Ford plant in Michigan. Ford said the facility has the ability to make at least another 100,000 respirators (Wayland, CNBC, 5/6).
    • A preliminary study conducted by researchers at Mount Sinai Health System that was published Wednesday in the Journal of the American College of Cardiology suggests some hospitalized Covid-19 patients treated with blood thinners could have better outcomes than those who aren't. The study—which was observational and not a randomized, controlled study—involved 2,773 patients, including 395 who were placed on ventilators. Among those who were placed on ventilators, 62.7% who were not given anticoagulant drugs died, compared with 29.1% among those who received anticoagulant drugs. However, among patients who were not on a ventilator, the percentages of patients who died was about the same among those who did and did not receive anticoagulant drugs (Cooney, STAT News, 5/6; Edwards, NBC News, 5/6).
    • Researchers hope that a new wearable device developed by researchers at Northwestern University and the Shirley Ryan AbilityLab could detect early symptoms associated with Covid-19, Axios reports. The device sits at the base of a patient's throat and detects coughing intensity patterns, as well as breathing sounds, heart rate, and body temperature. According to John Rogers, who led development of the device at Northwestern, researchers currently are remotely monitoring about 25 people, including some health care workers, who are wearing the device to assess its capabilities (Walsh, Axios, 5/6).
    • UnitedHealth Group on Thursday announced that it will provided a total of $1.5 billion in financial relief through premium rebates for Americans and employers enrolled in UnitedHealthcare's individual and small-group employer plans, as well as through cost-sharing waivers for individuals enrolled in the company's Medicare Advantage plans. According to UnitedHealth Group, qualifying members will see premium credits ranging between 5% and 20% on their June billing statements. Daily Briefing is published by Advisory Board, a division of Optum, which is a wholly owned subsidiary of UnitedHealth Group. UnitedHealth Group separately owns UnitedHealthcare (Coombs, CNBC, 5/7; Abelson, New York Times, 5/7; Mathews, Wall Street Journal, 5/7).

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