Coronavirus company news summary - Abbott launches Panbio Covid-19 antigen self-test in India - FluroTest files pre-emergency use authorisation with FDA - Verdict Medical Devices
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Coronavirus company news summary – Abbott launches Panbio Covid-19 antigen self-test in India – FluroTest files pre-emergency use authorisation with FDA

13 Jul 2021

Abbott has announced the launch of its Panbio Covid-19 antigen self-test in India. According to the current Indian Council of Medical Research (ICMR) advisory on self-use, these tests will be available to enhance testing of symptomatic and asymptomatic individuals and contacts of confirmed Covid-19 cases. The Panbio test has also received a CE Mark for over-the-counter use in adults and children, with or without symptoms. It is a minimally invasive nasal swab test that delivers results in just 15 minutes and correctly identifies 95.2% of the positive samples and 100% of negative samples.

Quidel Corporation has received the CE Mark for its Savanna multiplex molecular analyser and Savanna RVP4 assay. The CE Mark allows Quidel to commercialise its Savanna system across Europe, as well as other countries accepting the CE Mark. Savanna allows professionals to analyse up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes. Its initial Savanna RVP4 assay is a rapid, multiplexed nucleic acid test that helps in detecting and differentiating between influenza A, influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 RNA from nasal or nasopharyngeal swabs.

FluroTech and its wholly-owned subsidiary FluroTest Diagnostic Systems have filed a pre-Emergency Use Authorization (Pre-EUA) request with the US Food and Drug Administration (FDA). The Pre-EUA submission is the company’s latest step in seeking authorisation of its FluroTest pandemic response platform, which is designed to improve widespread access and scale to SARS-CoV-2 testing by leveraging robotics automation, fluorescence detection, biochemistry and cloud computing.