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.