Lophius Biosciences GmbH, Regensburg, Germany, and Mediphos Medical Supplies BV, Renkum, the Netherlands, have announced their distribution partnership for the in vitro diagnostic T-Track CMV. Under the recently signed collaboration agreement, Mediphos will exclusively market and sell Lophius’s novel immune-monitoring tool in Belgium, Luxemburg, and the Netherlands.

T-Track CMV is a standardized diagnostic test measuring human cytomegalovirus (CMV)-specific cell-mediated immunity with high sensitivity, supporting the risk stratification of CMV-related clinical complications among transplant recipients. By combining Lophius’s proprietary T-activation technology with the ELISpot method, T-Track CMV closely mimics the natural immune response to infection by measuring the functionality of a broad network of CMV-reactive effector cells.

“We are looking forward to collaborating with Mediphos as a strong, flexible, and innovative partner with an established customer network in the virology and transplantation area within the Benelux countries,” says Bernd Merkl, CEO and managing director of Lophius Biosciences. “Joining forces will help us leverage our CE mark and enter the market in another region of the European Union.”

CMV has a high seroprevalence in the human population of 30% to 90%. Among healthy individuals, however, replication of CMV is efficiently controlled by the immune system via cell-mediated immunity. To avoid uncontrolled CMV replication, immunosuppressed patients, like transplant recipients, are treated with antiviral medication either prophylactically in the first months after transplantation or preemptively based on CMV viral load measurement. However, the optimal duration of either prophylaxis or virological monitoring is not well defined.

In current practice, healthcare providers do not typically take into consideration either assessments of CMV-specific immunity or the ability of immunosuppressed patients to control virus replication via their immune systems. On one hand, such a practice this may expose patients with delayed immune reconstitution to higher risk for CMV disease. On the other hand, it may result in overtreatment of patients with reconstituted and protective CMV immunity. Avoiding unnecessary antiviral treatment would prevent unwanted side effects for patients and increased costs for the healthcare system.

By measuring CMV-specific cell-mediated immunity, T-Track CMV adds an additional dimension to anti-CMV treatment decisionmaking, complementing currently used viral load tests. Close monitoring of CMV-specific immunity using T-Track CMV, together with CMV viral load measurement, has the potential to improve risk stratification of patients and to help clinicians in their decision to start, discontinue, or adjust antiviral treatment.

“With the market introduction of T-Track CMV, we can offer an innovative tool that drastically improves anti-CMV therapy decisionmaking,” says Andre van der Mark, managing director of Mediphos Medical Supplies BV. “This new test perfectly complements our portfolio of high-quality diagnostic products to support therapeutic decisions and help to enhance patients’ quality of life.”

For more information, visit Lophius Biosciences GmbH and Mediphos Medical Supplies BV.