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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » BAG Diagnostics Gets CE Mark for Coronavirus MDx Test

BAG Diagnostics Gets CE Mark for Coronavirus MDx Test

Apr 30, 2020
|
staff reporter

NEW YORK – Germany's BAG Diagnostics said on Thursday that its ViroQ SARS-CoV-2 rapid PCR test has received CE IVD marking.

BAG Diagnostics' test is designed to detect SARS-CoV-2 genes E and RdRP in respiratory samples, according to the company's website. The company said that the assay's ability to detect a housekeeping gene that occurs in all cells can determine whether sufficient cell material is available for valid results, helping to eliminate false negatives.

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