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Medical Devices / Submissions and Approvals

Genetic Signatures Earns CE Mark for Pathogen Detection Kit

Dec. 18, 2018

Genetic Signatures was granted the CE Mark for its EasyScreen respiratory pathogen detection kit, allowing for its commercialization in Europe.

The kit can detect 14 common respiratory pathogens, such as mycoplasma pneumonia, influenza A and B and rhinovirus, the main cause of the common cold.

The device accepts up to 94 specimens per batch, requires minimal hands-on work from lab technicians and takes approximately 4.5 hours to detect the pathogens.

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