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Tag Archives: NeuMoDx

NeuMoDx HPV test gets CE mark

September 2020—NeuMoDx Molecular has received the CE mark for its NeuMoDx HPV Assay, a fully automated, in vitro real-time PCR-based assay for the qualitative detection of high-risk types of human papillomavirus DNA in cervical specimens. It specifically identifies HPV 16 and 18 while concurrently detecting 13 other common high-risk types at clinically relevant infection levels.

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NeuMoDx, Sentinel partnership

February 2020—NeuMoDx Molecular and Sentinel Diagnostics announced a partnership to develop diagnostic assays for the NeuMoDx 96 and 288 molecular systems. Sentinel’s real-time PCR assays will be adapted to the NeuMoDx 96 and 288 molecular systems and will incorporate Sentinel’s STAT-NAT technology, which provides the ability to stabilize the activity of a PCR mix, allowing room-temperature storage and transport. The test menu pipeline for the systems will include assays to detect and monitor post-transplant infections, parasitic and hospital-acquired infections, and respiratory infections, and for pharmacogenetics applications.

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NeuMoDx to add CE-IVD assay for HPV

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.

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NeuMoDx launches molecular systems at AMP

Nov. 12, 2018—NeuMoDx Molecular announced the U.S. launch of its FDA 510(k)-cleared NeuMoDx 288 Molecular System and its FDA-listed NeuMoDx 96 Molecular System at the Association for Molecular Pathology annual meeting in San Antonio. The fully automated systems integrate the molecular diagnostic process, from extraction to detection, with the first result available in approximately one hour. The analyzers offer operators ...

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FDA clears NeuMoDx 288 system, GBS assay

September 2018—NeuMoDx Molecular announced it has received FDA 510(k) clearance for its NeuMoDx 288 Molecular System and NeuMoDx GBS Assay. The fully automated NeuMoDx 288 is a scalable platform that integrates the diagnostic process, from extraction to detection, in approximately one hour. The analyzer can load up to 288 patient samples in a continuous random-access mode and features a walkaway time of more than six hours.

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