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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Sep 30, 2010

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Meridian Bioscience said this week that Health Canada has granted the company an approved medical device license for illumigene C. difficile, the company's Clostridium difficile molecular amplification assay.

The assay amplifies DNA using loop amplification technology to detect the presence of the toxin-producing region from the bacterium. Meridian said that the test provides highly accurate results in under an hour.

In July, Meridian received clearance from the US Food and Drug Administration to sell the test (PCR Insider, 7/15/2010). The company said it has also successfully launched the test in Australia, Taiwan, and most European markets.

The Scan

Gap in COVAX Doses

BBC News reports that COVAX is experiencing a vaccine shortfall, as the Serum Institute of India has paused exports.

Sanofi, GSK Report Promising Results

The Wall Street Journal reports that the candidate SARS-CoV-2 vaccine from Sanofi and GlaxoSmithKline has had encouraging early results.

Influence of Luck

The New York Times examines how the US avoided variant-fueled increases in COVID-19 cases.

PLOS Papers on Retina GWAS, Hantaan Virus, COVID-19 Phenome-Wide Association Study

In PLOS this week: genome-wide association study of retinal morphology, analysis of hantaan virus found in a mouse, and more.