Stores Sold Out Of Covid Tests? Things May Improve As FDA OKs Another One
The at-home test from ACON Laboratories likely will double testing capacity in the next few weeks, a top FDA official said. The FDA also greenlighted a new at-home test kit for covid and influenza A/B for ages 2 and up that can be ordered by a physician.
The Hill:
FDA Authorizes New Rapid COVID-19 Test, Says Capacity Will Double
The Food and Drug Administration (FDA) on Monday authorized a new rapid, at-home COVID-19 test, in a move it said is expected to double the availability of such tests in the coming weeks. The FDA said it has authorized a coronavirus test from the company ACON Laboratories. It is not the first authorization of such a test, which can deliver results in as little as 15 minutes, but, amid supply shortages, the move could be key in boosting their availability. (Sullivan, 10/4)
The FDA also authorized a combination covid/flu test —
Genomeweb:
FDA Approves Labcorp's Combo COVID-19/Flu Home Collection Kit
Laboratory Corporation of America has received Emergency Use Authorization from the Food and Drug Administration for a combined home collection kit for molecular testing for COVID-19 and influenza A/B. The kit is intended for individuals two years of age and older and is available at no upfront cost to those who meet clinical guidelines, which include individuals experiencing symptoms, those who have been exposed to someone with COVID-19, or those who have been recommended for testing by a healthcare provider. The kit will become available in early October and can be ordered by an individual's physician. (10/4)
In news about covid treatments —
Bloomberg:
AstraZeneca Seeks U.S. Emergency Approval For Covid Antibody
AstraZeneca Plc submitted its antibody cocktail for U.S. emergency approval to prevent Covid-19 infection as therapeutic options for the pandemic broaden beyond vaccination. It’s the first regulatory filing for the medicine, which was 77% effective in preventing symptomatic Covid in a clinical trial that included patients with high-risk factors for severe infection. The cocktail can supplement vaccines for people who haven’t mounted a strong response to the shots -- or to protect those who couldn’t be immunized. The news comes just days after Merck & Co. fueled optimism that it will soon have the first Covid pill. Both treatments could offer a simple way to treat many patients before they ever reach the hospital. (Fourcade, 10/5)
Stat:
Questions Emerge About Cost Of Merck Pill To Treat Covid-19
Behind the unvarnished enthusiasm over an experimental Covid-19 pill, questions are emerging about the cost of the treatment and the leverage the U.S. government may have to address excessive pricing. At issue is molnupiravir, which is being developed by Merck and Ridgeback Biotherapeutics. Last week, the companies released top-line data showing the pill reduced the risk that newly diagnosed patients would be hospitalized by about 50%. Moreover, no deaths were reported among those given the pill, compared with eight deaths among people who received a placebo. (Silverman, 10/4)
Axios:
Taxpayers Funded Development Of COVID-19 Antiviral Pill Molnupiravir
The antiviral pill that showed promising results against severe COVID-19 was originally developed at Emory University with $35 million of taxpayer grants. The federal government consequently owns rights to some of the molnupiravir's patents, which could factor into future purchasing agreements with Merck, which sells the drug. (Herman, 10/5)
Also —
AP:
Nevada Adds Rapid Tests To COVID Tally, Joining Most States
Nevada health officials as of Monday are counting results from rapid antigen tests in the coronavirus data that they present to the public and use to determine whether the pandemic is prevalent enough to trigger mask and capacity mandates. The state updated its health response dashboard, adding more than 600,000 tests to its count. The dashboard started displaying “cumulative tests” on its testing page and divides the new infections into “confirmed cases” and “probable cases” on its page that reports total cases. (10/5)
Stateline:
COVID Antibody Tests Won't Tell You What You Want To Know
Talk of the need for COVID-19 booster shots has prompted many Americans to seek antibody tests. In most cases, however, getting an antibody test to determine immunity is a fool’s errand, infectious disease doctors agree. The tests for antibodies, also known as serology tests, do not provide the answers that most people are seeking. Both the federal Centers for Disease Control and Prevention and the Food and Drug Administration advise against using antibody tests to determine one’s level of immunity against COVID-19. So does the Infectious Disease Society of America, which represents infectious disease specialists. (Ollove, 10/1)
