Coronavirus company news summary – FDA authorises first Covid-19 test for self-testing at home – PharmaJet and Diomics partner on immune response monitoring

18 November 2020 (Last Updated November 18th, 2020 09:28)

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the first Covid-19 diagnostic test to conduct self-testing at home. The Lucira COVID-19 All-In-One Test Kit is a molecular single use test offers rapid results in the detection of the SARS-CoV-2 virus.

Iran's first vice president Es’haq Jahangiri has hosted the launch of the country’s first rapid Covid-19 antibody test, reports the Tehran Times. Iran is the fifth country to have developed rapid testing technology, following the US, UK, South Korea and China. The test, which can detect the SARS-CoV-2 virus in just 15 to 20 minutes, has been used on approximately 500 patients under the supervision of the Pasteur Institute of Iran.

Trinity Biotech, a developer of diagnostic test kits, has started selling its Covid-19 antibody test in the US, reports the Irish Times. The company is expecting to obtain the CE Mark that allows the product to be sold in the European Union (EU) shortly. The company’s IgG ELISA antibody test still awaits FDA approval, while having sought approval for emergency use authorisation in the country.

PharmaJet has announced that its Tropis Needle-free Injection System will be used by Diomics, a San Diego-based biotech company, to deliver a biopolymer to detect the formation of an immune response to a SARS-CoV-2 protein. The Department of Defense has also awarded the company over $2m to fast-track testing and clinical trials with its Diocheck system, to begin in December 2020.