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NeuMoDx Molecular Nabs CE Mark for HIV Viral Load Assay

NEW YORK – NeuMoDx Molecular announced Monday that its PCR-based HIV viral load test received CE marking.

Results from the NeuMoDx HIV-1 assay, which detects HIV-1 RNA, are available in approximately 80 minutes. The test runs on the fully automated NeuMoDx 96/288 Molecular Systems, NeuMoDx President and COO Sundu Brahmasandra said in a statement. 

The Ann Arbor, Michigan-based firm offers other bloodborne viral tests for hepatitis B and hepatitis C viral loads. The company's analyzers integrate extraction and detection, allowing users to load patient samples continuously for high-throughput sample processing, the firm said. The analyzers also use NeuDry reagents that don't require refrigeration and have an ambient temperature shelf life of more than a year. 

In May, NeuMoDx received CE marking for its multiplex RT-PCR SARS-CoV-2 test. The test received Emergency Use Authorization from the US Food and Drug Administration in March.   

In 2018, NeuMoDx entered a partnership and milestone-based merger agreement with Qiagen, a firm that Thermo Fisher Scientific is in the process of acquiring.