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 the ability to load up to 288 and 96 patient samples, respectively, in a continuous, random-access workflow, resulting in on-demand, high-throughput sample processing with a walkaway time of up to eight hours.
The company’s NeuDry reagents used with the systems require no refrigeration and are extremely robust with an onboard stability of up to 60 days and ambient temperature shelf life of more than one year. In addition to focusing design and development efforts on tests to detect sexually transmitted and infectious diseases, NeuMoDx offers a range of general-purpose reagents and consumables for use in developing qualitative and quantitative laboratory-developed tests for use with the NeuMoDx systems to detect and amplify DNA and RNA targets.