NeuMoDx07.24.19
NeuMoDx Molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, is launching CE-IVD assays for Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV).
Cytomegalovirus and Epstein-Barr Virus 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. Post-transplant 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 reactivated 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.
Cytomegalovirus and Epstein-Barr Virus 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. Post-transplant 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 reactivated 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.