The FDA yesterday issued an emergency use authorization (EUA) for the first over-the-counter molecular test authorized for use with saliva specimens to Aptitude Medical Inc. for their Metrix COVID-19 Test. This single-use molecular in vitro diagnostic test is authorized for nonprescription, at-home use with anterior nasal swab and saliva samples, self-collected from people aged 14 years or older, or adult-collected from people aged 2 years or older, including people without symptoms or other epidemiological reason to suspect COVID-19. Negative test results from saliva samples are presumptive, and negative test results from anterior nasal swab samples from asymptomatic individuals should be treated as presumptive. Negative test results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. FDA said negative test results should be considered in the context of a person’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with additional testing, if appropriate.
XBB, BQ.1.1, BA.2.75.2 could be some of the SARS-CoV-2 variants swarming this winter in the U.S., the Washington Post reports: “The pace of evolution is so fast that many scientists depend on Twitter to keep up. A month ago, scientists were worried about BA.2.75, a variant that took off in South Asia and spawned a cloud of other concerning sublineages. In the United States, BA.4.6 and BF.7 have been slowly picking up steam. A few weeks ago, BQ.1.1 started to steal the spotlight — and still looks like a contender to take over this fall in Europe and North America. A lineage called XBB looms on the sidelines, and threatens to scramble the forecast.…”
Six e-cigarette manufacturers are facing complaints for permanent injunctions filed yesterday by the U.S. Department of Justice on behalf of the FDA. These cases represent the first time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.