As the Omicron variant of COVID-19 sweeps across the globe, the Biden administration has announced a program to purchase 500 million rapid antigen tests to help slow the pandemic. The news comes at an especially critical time, given the increased transmissibility of the Omicron variant, but the promised volume is unlikely to be achieved by the first day of January 2022.
The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.
The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.
The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.
Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer.
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
