The US Food and Drug Administration (FDA) has granted an amendment to GenBody’s Emergency Use Authorization (EUA) for its Covid-19 antigen test kit to include the usage of anterior nasal swabs. The visually readable, point of care test qualitatively identifies the nucleocapsid protein antigen from the SARS-CoV-2 virus. GenBody supplies direct nasopharyngeal and anterior nasal swab antigen tests that can be utilised for Covid-19 testing in CLIA-certified labs. The company has also received a US National Institutes of Health (NIH) grant of $10m to boost the manufacturing of its tests in the country.
Co-Diagnostics‘ Logix Smart SARS-CoV-2 2-Gene multiplex test has secured approval for use and supply in the UK. The test has been validated under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA) of the United Kingdom Health Security Agency (UKHSA). To be offered for supply through Clent Life Science, the company’s distributor in the country, the test is validated for usage with various kinds of samples, including saliva specimens.
Medical data management company TESTD has reported that its platform has met the requirements of the US Occupational Safety and Health Administration’s (OSHA) just-filed Emergency Temporary Standard (ETS) for Covid in one software solution. The TESTD platform automates the scheduling of medical tests and immunisation, handles medical data and consolidates it for straightforward reporting. Leveraging blockchain and various other technologies, the platform protects and encrypts all data, ensuring compliance with the new government requirements.