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December 10, 2021updated 07 Jan 2022 8:29am

Coronavirus company news summary – GenBody Covid-19 antigen test kit obtains FDA EUA for asymptomatic testing – Seegene launches novel Covid-19 PCR test to detect viral variants

By Kezia Parkins

The US Food and Drug Administration (FDA) has amended the initial Emergency Use Authorization (EUA) of GenBody America’s Covid-19 antigen test kit to include an indication for use in asymptomatic people or with other epidemiological reasons to suspect an infection. GenBody America CEO David Yoo said: “This new ‘claim’ allows CLIA-waived laboratories to use GenBody test kits to test individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.” The updated EUA also permits the test kit for use with anterior nasal swab samples. 

Seegene has introduced its Novaplex SARS-CoV-2 Variants VII assay that can identify various SARS-CoV-2 variants including the Omicron variant and its stealth version. The novel reverse transcription-polymerase chain reaction (RT-PCR) test targets five analytes including the RdRP gene to detect positive cases of Covid-19, and also three main S-gene mutations of Omicron from one tube itself. The company has validated the test using different SARS-COV-2 nucleic acid samples of Alpha, Beta, Gamma, Delta, and Omicron variants.

Genetic Technologies has obtained a patent for its new geneType COVID-19 Risk Test in the US. With the development, the company has collaborated to directly sell the test in the region through the ‘Vitagene’ platform of IBX and 1health. Leveraging genetic and clinical data, the test can potentially predict the severity of Covid-19 in individuals aged 18 years and above and offer a risk score. This score may be utilised to assess the risk of an individual contracting severe disease. 

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