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NeuMoDx Molecular Receives CE Mark for Quantitative BK Viral Assay

NEW YORK – NeuMoDx Molecular announced on Wednesday that it has received the CE mark for its viral load monitoring assay.

In collaboration with Milan, Italy-based Sentinel Diagnostics, NeuMoDx developed the Quantitative BK virus (BKV) assay, which is intended to help clinical manage infection in the critical organ transplant patient population. The partnership strengthens the NeuMoDx transplant menu, which already includes tests with CE mark for Epstein–Barr virus and cytomegalovirus viral load monitoring for the management of immunocompromised patients, NeuMoDx said.

The Quantitative BKV virus assay is based on Sentinel Diagnostics' STAT-NAT patented technology and is available in a ready-to-use lyophilized format. The assay is stable at room temperature for two years and provides state of the art performance, according to Ann Arbor, Michigan-based NeuMoDx.

"The availability of the NeuMoDx BKV Quant Assay, along with the previously commercialized NeuMoDx CMV and EBV Quant Assays, moves us significantly closer to providing a comprehensive transplant virology monitoring solution," NeuMoDx President and Chief Operating Officer Sundu Brahmasandra said in a statement.

From extraction to detection, the assay integrates the entire molecular diagnostic process with the first results available in about 60 minutes for viral load tests, NeuMoDx said.