Ann Arbor, Michigan
(July 1, 2018) – NeuMoDxTM Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today it will be previewing its FDA 510(k) cleared NeuMoDxTM 288 Molecular System during the 70th AACC Annual Scientific Meeting and Clinical Lab Expo to be held in Chicago, IL July 29th- August 2, 2018. NeuMoDx will be presenting in Booth # 1680 in the McCormick Place exhibit hall.
The fully automated NeuMoDx 288 Molecular System is the first offering in a family of scalable platforms for integrating the entire PCR process – from extraction to detection or sample to result –in approximately one hour to first result. In addition to focusing design and development efforts on tests to detect Sexually Transmitted and Infectious Diseases, NeuMoDx has developed and will commercialize a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NeuMoDx 288 Molecular System to detect and amplify DNA and RNA targets. This innovative system offers the ability to load up to 288 patient samples onto a continuous random-access platform with simultaneous detection of multiple analytes from multiple specimens, resulting in high throughput sample processing and true operator walkaway of more than six hours. The revolutionary dry format assays and reagents are extremely robust with an on-board stability of greater than 60 days and room temperature storage of greater than one year, greatly increasing the operating efficiency while minimizing the waste associated with systems requiring manual reconstitution of lyophilized reagents.
“Laboratory developed tests (LDTs) continue to play a critical role and, in many instances, represent the standard of care for diagnosis, monitoring, and guiding patient care especially for indications without a viable in-vitro diagnostic (IVD) test. Automation of real-time PCR based LDTs, within a system architecture like the NeuMoDx Molecular System that enables extremely easy and efficient integration of LDT workflows, can help significantly increase productivity of clinical laboratories”, commented Stephen Young, Director of Research and Clinical Trials, TriCore Reference Laboratories (Albuquerque, NM).
NeuMoDx Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve.