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NEW YORK ─ NeuMoDx Molecular said on Monday that it has received the CE mark for a molecular diagnostic test for high-risk types of human papillomavirus, one of the main causes of cervical cancer.

The Ann Arbor, Michigan-based molecular diagnostics firm developed its NeuMoDx HPV Assay in collaboration with Amsterdam, the Netherlands-based Self-screen.

NeuMoDx HPV is a fully automated real-time PCR assay for the qualitative detection of high-risk types of HPV DNA in cervical specimens, which runs on the NeuMoDx 96 and NeuMoDx 288 molecular systems.

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Antibody testing is expected to play an important role in the management of the COVID-19 pandemic. 


As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.