NeuMoDx Molecular, Ann Arbor, Mich, a molecular diagnostics company focused on central laboratory customers, has launched CE-marked assays for cytomegalovirus (CMV) and Epstein-Barr Virus (EBV).
CMV and EBV are herpes viruses found in up to 90% of the adult population. Usually latent, the presence of the viruses may lead to serious complications for patients receiving solid organ transplants. Posttransplant lymphoproliferative disease (PTLD) is a specifically life-threatening complication of solid organ transplantation. The disease is associated with active replication of EBV when an organ from a seropositive donor is transplanted or with reactivation during treatment with immunosuppressive drugs administered to prevent the patient’s immune system from attacking the transplanted organ. The risk of complications requires transplant recipients to receive regular monitoring for CMV and EBV in order to avoid or treat the complications associated with PTLD.
The new assays integrate the entire molecular diagnostic process from sample extraction to detection with the first result available in approximately 1 hour. Operators can load patient samples in a continuous, random-access workflow for high-throughput sample processing of up to 8 hours.
“Providing fast and accurate monitoring of CMV and EBV is critical in the long-term care of transplant recipients,” says Dan Harma, chief commercial officer at NeuMoDx. “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 test systems require no refrigeration and have an onboard stability of up to 60 days. Their ambient temperature shelf life is greater than 1 year. In addition, the unitized format of the reagents increases operating efficiency while minimizing the waste associated with systems requiring manual reconstitution and use of bulk-format lyophilized reagents.
For more information visit NeuMoDx.
Featured image: The NeuMoDx 288 molecular analyzer from NeuMoDx Molecular.