Coronavirus company news summary - FDA grants EUA to two Thermo Fisher Covid-19 assays - CapeBio to provide domestic Covid-19 PCR test kit production in South Africa - Verdict Medical Devices
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Coronavirus company news summary – FDA grants EUA to two Thermo Fisher Covid-19 assays – CapeBio to provide domestic Covid-19 PCR test kit production in South Africa

17 Aug 2021

Thermo Fisher Scientific has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its new TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0. The assays are designed to offer higher target redundancy to address existing mutations and emerging variants of the SARS-CoV-2 virus, the company said. The PCR Combo and RNase P Combo tests, which target eight genes across three regions of SARS-CoV-2, deliver results in two and three hours, respectively.

South Africa-based biotechnology company CapeBio has received approval from the country’s regulatory authority to manufacture rapid Covid-19 PCR test kits locally. The test kits are jointly developed by the company and the Council for Scientific and Industrial Research (CSIR). Domestic manufacturing is expected to decrease the country’s dependence on imports and enable prompt access to Covid-19 testing. The initial batches of the test kits, being made at the company’s Centurion facilities, are set to reach the market before the end of August. At full capacity, CapeBio will reportedly be able to manufacture up to 5,000 kits per day, and each kit provides for 1,000 tests.

Researchers from the National Institutes of Health (NIH) have created a faster sample preparation technique for the identification of SARS-CoV-2. The new method does not require genetic RNA material extraction, simplifying sample purification and potentially lowering test time and cost. To preserve viral RNA in samples for detection by reverse transcription-quantitative real-time polymerase chain reaction (RT-qPCR), the researchers used a chelating agent developed by lab supply company Bio-Rad. The team assessed nasopharyngeal and saliva samples with different virion concentrations and observed that the specimens can be used to identify RNA directly.