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Genedrive Rapid Molecular COVID-19 Test Receives CE Mark

NEW YORK – UK molecular diagnostics company Genedrive said on Wednesday that its rapid molecular COVID-19 test has received CE marking.

The point-of-care test uses reverse-transcription loop-mediated isothermal amplification and returns positive results in eight minutes, with negative results available in 17 minutes. It targets the ORF1ab and N genes of SARS-CoV-2 in mid-turbinate nasal swab samples and uses a proprietary buffer solution to get results without viral extraction, the company said in a statement.

In a validation study with 149 samples, sensitivity of the Genedrive COV19-ID Kit was 98.2 percent and specificity 98.9 percent, the company said. The kit was able to detect all Delta variants in that cohort and is expected to detect the Omicron variant based on genome sequence data, Genedrive noted.

The company added that it is currently searching for commercial partners to distribute the test in Europe. Genedrive CEO David Budd said in a statement that the CE mark allows the firm to "move forward with our commercial plans."

The firm received CE marking for its SARS-CoV-2 PCR test kit in May 2020.

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