Antiviral treatment against CMV is costly and has serious side effects. Today, in the pre-emptive management strategy, the decision to treat after transplantation is still solely based on viral load detection while one of the strongest risk factors for CMV disease is actually a lack of CMV-specific immunity. Alternatively, transplant patients are treated prophylactically without taking the patient’s viral load or immune competence into account.
T-Track® CMV is a standardized diagnostic test measuring human Cytomegalovirus (CMV)-specific cell-mediated immunity with high accuracy. As a novel tool in the market, Lophius’ test supports for the first time a truly personalized risk stratification of CMV-related clinical complications among transplant recipients.
The T-Track® CMV kit is based on the in vitro stimulation of mononuclear cells of the peripheral blood (PBMC) with two immunogenic CMV-specific proteins: T-activated® IE-1 and T-activated® pp65. By combining Lophius’ proprietary T-activation technology with the widely established ELISpot technology, T-Track® CMV closely mimics the natural immune response to infection by measuring the functionality of a broad network of CMV-reactive effector cells. Monitoring this CMV-specific cell-mediated immunity in combination with determining the viral load enables the physician to take personalized decisions as when to start, stop or resume anti-CMV therapy with the opportunity to reduce side effects, treatment cost and improve patient health.
Low risk for CMV complication
Decreasing or low viral load, stable increasing CMV-CMI
Viral load detection:
Occasional monitoring in parallel to T-Track® CMV
Antiviral therapy: None or discontinue
High risk for CMV complication
Increasing viral load (above threshold), low or decreasing CMV-CMI
Viral load detection:
Frequent monitoring in parallel to T-Track® CMV
Antiviral therapy: Start or continue
A matrix-view for CMV risk stratification post-transplantation based on cytomegalovirus-specific cell-mediated immunity (CMV-CMI) and viral load (VL) shows the potential to avoid unnecessary antiviral treatment in a significant patient population.
T-Track® CMV is currently being used and further evaluated in both solid-organ and hematopoietic stem cell transplantation settings.
We also see a substantial medical need for CMV risk stratification in gynecology to predict CMV transmission from mother to child in case of a CMV infection during pregnancy.
The CE-marked diagnostic kit T-Track® CMV is available in Europe and distributed in collaboration with a growing network of distribution partners.