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NeuMoDx to add CE-IVD assay for HPV

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December 2019—NeuMoDx Molecular announced an agreement with Amsterdam-based biotech company Self-screen BV to implement a CE-IVD-marked molecular diagnostic test for high-risk strains of human papillomavirus on the NeuMoDx 288 and NeuMoDx 96 molecular systems.

The HPV assay developed by Self-screen is a real-time PCR-based test that detects 15 high-risk genotypes of human papillomavirus DNA. Under the agreement, Self-screen will handle regulatory processes to obtain the CE-IVD mark while NeuMoDx will manufacture and sell the assay.

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