Two peer-reviewed scientific papers have recently assessed performance of the T-Track CMV test from Lophius Biosciences GmbH, Regensburg, Germany.1, 2
The scientific publications outlined the CE-marked in vitro diagnostic test’s high reliability and sensitivity as an immune-monitoring tool, with the potential to improve risk stratification for human cytomegalovirus (CMV)-related clinical complications among renal transplant recipients. Lophius Biosciences is a privately held biotech company focusing on the development and marketing of innovative T cell-based diagnostic systems to improve therapy control and personalized treatment of patients in the areas of autoimmune, infectious, and transplantation diseases.
CMV is endemic in all human populations, with a high seroprevalence of 30% to 90%. In healthy individuals, CMV replication is efficiently controlled by the immune system via cell-mediated immunity. In immunosuppressed patients such as transplant recipients, however, impaired functionality of cell-mediated immunity is often associated with severe clinical complications due to uncontrolled virus replication.
Currently, in the absence of knowledge about their immunosuppressive state, patients are treated with antiviral medication either prophylactically in the first months after transplantation or following a preemptive strategy based only on CMV viral load measurements. Assessment of CMV-specific immunity and the ability of immunosuppressed patients to control virus replication via their immune system are not taken into consideration. This may result in overtreatment of patients, associated with unnecessary side-effects and costs for the healthcare system.
By measuring CMV-specific cell-mediated immunity, T-Track CMV adds a new dimension to antiviral treatment decision-making, complementing the currently used viral load tests. The close monitoring of CMV-specific immune response 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.
The two scientific papers show that the Lophius IVD test is a highly standardized, reliable immune-monitoring tool exhibiting great sensitivity for the measurement of the CMV-specific cell-mediated immune response. The performance of the test is based on the stimulation of isolated blood cells with CMV proteins ‘activated’ with the proprietary Lophius T-activation technology. In addition, a clinical study in hemodialysis CMV-seropositive patients prior to renal transplantation demonstrated a sensitivity for T-Track CMV of 90%.
“The recent publications clearly demonstrate the technical capabilities of our assay T-Track CMV and give an outlook toward its ability to support personalized CMV therapy management,” says Bernd Merkl, CEO and managing director of Lophius Biosciences. “We are looking forward to the results of ongoing clinical studies in allogeneic hematopoietic stem cell and solid-organ transplant recipients to confirm the full clinical potential and the health-economic benefit of our test.”
REFERENCES
- Barabas S, Spindler T, Kiener R, Tonar C, et al. An optimized IFN-? ELISpot assay for the sensitive and standardized monitoring of CMV protein-reactive effector cells of cell-mediated immunity. BMC Immunol. 2017;18(1):14; doi: 10.1186/s12865-017-0195-y.
- Banas B, Böger CA, Lückhoff G, et al. Validation of T-Track CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 2017;18(1):15; doi: 10.1186/s12865-017-0194-z.
