RapidRona has recieved Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 sample self-collection kit. The company looks to enhance rapid access to in vitro diagnostic testing for Covid-19 as the disease stretches into the flu season.
Cepheid has received CE-IVD marking for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular test that helps detect Covid-19, Flu A, Flu B, and RSV virus from one sample. The test, which delivers results in 36 minutes, received emergency use authorisation from the FDA in September 2020, and is now available in European markets.
The FDA notified the entry of two ender Covid-19 tests, ender LAB and ender MASS, into the US market. ender diagnostics North America, the US subsidiary of ender diagnostics, is ready to deliver the 30-minute rapid, reliable, and cost-effective Swiss-developed Covid-19 testing kits to diagnostic laboratories to increase testing capacities.
Genomica, a Spanish molecular diagnostic company, has launched a new PCR test to detect and differentiate between Covid-19 and other respiratory viruses such as Influenza A and B and respiratory syncytial virus (RSV). The new test has already obtained CE marking, is available across diagnostic laboratories and hospitals.