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NeuMoDx Gets CE Mark for Cytomegalovirus, Epstein-Barr Virus Tests

NEW YORK – NeuMoDx Molecular said this week that its molecular assays for cytomegalovirus (CMV) and Epstein-Barr virus have received CE-IVD marking and are now commercially available in Europe and other locations that recognize the designation.

NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems, which provide different levels of throughput. 

Patient samples can be loaded in a continuous random-access manner, resulting in on-demand, high-throughput sample processing with an operator walkway window of up to eight hours and first test results available in about an hour, the company said.

In September, Qiagen and NeuMoDx signed a partnership and merger agreement related to the commercialization of the NeuMoDx test systems. Under the agreement, Qiagen is distributing the systems in Europe and other ex-US markets. Qiagen also owns about 20 percent of Ann Arbor, Michigan-based NeuMoDx, and has the right to acquire all remaining shares for a predetermined price of approximately $234 million, subject to the achievement of regulatory and operational milestones.