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Genomtec Gets CE-IVD Mark for Point-of-Care Respiratory Disease Test

Jun 08, 2022 | staff reporter

NEW YORK — Polish diagnostics firm Genomtec said on Wednesday that it has received CE-IVD marking for the Genomtec ID Respiratory Panel 5-Plex, a point-of-care molecular diagnostic panel for five respiratory infections.

The test is designed to detect influenza A and B, respiratory syncytial virus, SARS-CoV-2, Mycoplasma pneumoniae, and Chlamydophila pneumoniae nucleic acid, and runs on the company's portable Genomtec ID Analyzer instrument. Results are available within 25 minutes.

Genomtec said that it now aims to sign on European distributors for the test, as well as validate it with early customers and prepare for scalable production. Earlier this year, the company signed a distribution pact for the Genomtec ID analyzer in Greece with Atropos.

In May, Genomtec received CE-IVD marking for a saliva-based COVID-19 test that runs on standard RT-PCR instrumentation.

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Molecular Diagnostics
Infectious Disease
COVID-19
Point-of-Care Testing
Regulatory News & FDA Approvals
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Microarrays & Multiplexing
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