News

OCT
31
2018

NeuMoDx™ Molecular announces today, the U.S. launch of its FDA 510(k) cleared NeuMoDx™ 288 Molecular System and its FDA Listed NeuMoDx™ 96 Molecular System at AMP Show in Texas

Ann Arbor, MI (November 1, 2018) – NeuMoDxTM Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today the US launch of its FDA 510(k) cleared NeuMoDxTM 288 Molecular System and its FDA Listed NeuMoDxTM  96 Molecular System. Both systems will be exhibited in booth 627 the Association for Molecular Pathology Annual Meeting and Expo which is at the Henry B. Gonzalez Convention Center in San Antonio, TX between November 1st and 3rd.  

The fully automated NeuMoDxTM systems integrate the entire molecular diagnostic process – from extraction to detection or ‘sample to result’ – with the first result available in approximately one hour.  These innovative 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 true operator walkaway window of up to eight hours.   “I would like to thank the entire NeuMoDxTM team for the work they have accomplished in the design and development of these revolutionary molecular diagnostic solutions and am excited about the real benefits they will deliver to our central laboratory customers in the U.S. and the patients they serve,” commented Jeff Williams, Chairman and CEO, NeuMoDxTM Molecular.  

The proprietary NeuDryTM reagents used with the systems require no refrigeration and are extremely robust with an on-board stability of up to 60 days and ambient temperature shelf life of greater than one year.  Additionally, the unitized format of the NeuDry reagents significantly increases operating efficiency while minimizing the waste associated with systems requiring manual reconstitution and use of bulk format lyophilized reagents.   In addition to focusing design and development efforts on tests to detect Sexually Transmitted and Infectious Diseases, NeuMoDxTM offers a broad range of general-purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDTs) for use with the NeuMoDxTM systems to detect and amplify DNA and RNA targets.  “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 that enables extremely easy and efficient integration of LDT workflows, like the NeuMoDx Molecular System, can help significantly increase productivity of clinical laboratories“, commented Dr. Steve Young, Director of Research and Clinical Trials at TriCore Reference Laboratories (Albuquerque, NM).  Dr. Young will be presenting a Corporate Workshop on October 31st at 1:00pm in Room 304C in the Henry B. Gonzalez Convention Center.

About NeuMoDxTM
NeuMoDTM 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.  For more information visit www.neumodxmolecular.com.

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