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December 8, 2021updated 07 Jan 2022 8:24am

Coronavirus company news summary – Fluidigm’s Covid-19 RT-PCR assay detects Omicron variant of SARS-CoV-2 – International Isotopes signs deal to market Covid-19 antibody test 

By Kezia Parkins

Fluidigm has reported that its Fluidigm Advanta Dx SARS-CoV-2 RT-PCR Assay can detect the Omicron variant of SARS-CoV-2. The extraction-free test, which runs on the Biomark platform of the company, can qualitatively identify the nucleic acid from the virus in people suspected of having Covid-19. Authorised for use under the Food and Drug Administration Emergency Use Authorization, the saliva-based assay showed complete agreement with test results obtained using nasopharyngeal samples.

International Isotopes (INIS) has signed an exclusive licencing agreement with Memorial Sloan Kettering Cancer Center (MSK) in the US for a radiolabelled antibody test for Covid-19. As per the deal, the company will gain exclusive rights to market the test. Earlier this year, INIS and MSK signed a sponsored research agreement to develop a precise cost-effective, portable rapid and saliva-based Covid-19 test using radiolabelled antibodies. The test needs a small quantity of nearly 1ml of saliva sample and delivers results in nearly 30 minutes.

The US Food and Drug Administration (FDA) has notified that the performance of some Covid-19 tests could be impacted by the Omicron variant of the SARS-CoV-2 virus. The agency added the DTPM COVID-19 RT-PCR Test of Tide Laboratories to the list of affected tests. As the single target test acts on a segment of the N-gene where deletions arise due to the Omicron variant, the test may not be able to detect Covid-19 infection. 

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