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NeuMoDx™ Launches CE-IVD Assays For CMV & EBV

Ann Arbor, MI (July 23, 2019) – NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced today the launch of CE-IVD assays for Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV).

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) are herpes viruses found in up to 90% of the adult population.  Usually latent, the presence of these viruses may lead to serious complications for patients receiving solid organ transplants. Posttransplant lymphoproliferative disease (PTLD), specifically,  is a life-threatening complication of solid organ transplantation and is associated with active replication of EBV when an organ from a seropositive donor is transplanted or reactivation during treatment with immunosuppressive drugs administered to the transplant recipient to prevent their immune system from attacking the transplanted organ.   As a result of the risk of complications, transplant recipients require regular monitoring for CMV and EBV to ensure appropriate therapy can be administered to avoid or treat the complications associated with PTLD.

NeuMoDx™ Molecular offers solutions that 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 provide operators with the ability to load patient samples 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. “Providing fast and accurate monitoring of CMV and EBV is critical in the long-term care of transplant recipients.” said Dan Harma, NeuMoDx™ Chief Commercial Officer.  “Laboratories around the world will be able to deliver high quality results to clinicians and the patients they serve in a more rapid and efficient manner.”

The proprietary NeuDry™ 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.  Furthermore, 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, NeuMoDx™ 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 NeuMoDx™ systems to detect and amplify DNA and RNA targets.

About NeuMoDx™

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.  For more information visit www.neumodx.com.