The FDA has expanded an emergency authorization of a COVID-19 diagnostic to allow it to test samples gathered by rinsing a person’s mouth with simple saline. By swishing and gargling a small amount of solution for 30 seconds and then spitting it into a funnel and vial, the test both eliminates the need for a nasal swab and assists people who may have trouble providing sufficient amounts of saliva for a direct test.
In addition, the samples can be stored for up to 72 hours at room temperature before processing. The prescription-only OraRisk molecular diagnostic test, developed by Access Genetics and its subsidiary OralDNA Labs, is designed to be administered by a healthcare professional.The same test was previously granted a green light by the agency in mid-July for use with nasopharyngeal, nasal and oral swabs.
AstraZeneca’s Japanese COVID-19 Vaccine Trial back up, U.S. Still Paused
Clinical trials of AstraZeneca and Oxford University’s experimental COVID-19 vaccine have resumed in Japan, almost a month after being put on hold due to an illness of a British volunteer, while discussions with U.S. authorities continue. The British drugmaker said on Friday the early-to-mid-stage trial for the vaccine against the novel coronavirus resumed in Japan after consultations with the national health regulator, the Japanese Pharmaceuticals and Medical Devices Agency. Global trials of the vaccine, called AZD1222 or ChAdOx1 nCoV-19, were put on hold on Sept. 6 after a study participant fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
Trials in the UK, Brazil, South Africa and India had already restarted, but U.S. trials remain paused as regulators widened their probe, Reuters reported on Wednesday. AstraZeneca has called the halt a standard review procedure, and a document posted online by Oxford university last month stated the illness may not have been associated with the vaccine.