Clinical trials coordination and cooperations
Together with industry and research partners Lophius Biosciences performs various cooperation projects to further validate our existing products and for the development of new products.
Contact us if you are interested in a cooperation or have questions about our clinical trials.
Clinical Trial Coordination
Validation of T-Track® CMV in hemodialysis patients
“T-Track® CMV is a reliable and sensitive assay for the detection of CMV-specific cell-mediated immunity in patients eligible for kidney transplantation”
This multicenter observational study aimed to determine Lophius Biosciences’ T-Track® CMV sensitivity in hemodialysis patients and compare it to that of competitor products. T-Track® CMV showed a 90% sensitivity in CMV-seropositive patients, compared to 73% for QuantiFERON®-CMV and 77% for six selected iTAg™ MHC Tetramers.
- Banas B. et al. (2017). Validation of T-Track® CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 18(1):15.
CMValue study: Clinical validation of Lophius Biosciences’ kit T-Track® CMV in kidney transplant recipients
“T-Track® CMV is a sensitive immune-monitoring tool in immunosuppressed renal transplant recipients”
This multicenter observational study aimed to validate the suitability of Lophius Biosciences’ T-Track® CMV to assess the functionality of CMV-specific cell-mediated immunity in immunocompromised patients following kidney transplantation.
- Banas B et al. (2018). Clinical validation of a novel enzyme‐linked immunosorbent spot assay‐based in vitro diagnostic assay to monitor cytomegalovirus‐specific cell‐mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. Transpl. Int. 31(4):436-450.
AlloProtectCMV study: Clinical validation of Lophius Biosciences’ T-Track® CMV in allo-HSCT recipients
“Identification of a possible prognostic marker for higher risk of recurrent CMV reactivation”
This on-going multicenter observational study in a cohort of allogenic hematopoietic stem cell transplantation (allo-HSCT) recipients aims to validate the suitability of Lophius’ T-Track® CMV assay to assess the functionality of CMV-reactive effector cells and to predict recurrent CMV reactivation in allo-HSCT patients.
CMV-CMI study: Cell-mediated immunity for prevention of CMV disease in SOT patients
“T-Track® CMV as a decision guidance for the duration of antiviral prophylaxis following SOT”
This on-going interventional randomized controlled trial in high-risk solid-organ transplant (SOT) recipients aims to adapt the duration of antiviral prophylaxis according to the result of Lophius’ T-Track® CMV assay. The two main end-points of the study are clinical outcome and health-economic benefit.
T-Track® CMV assay development and performance characteristics in healthy individuals
“An optimized IFN-y ELISpot assay for the sensitive and standardized monitoring of CMV”
In this study, performance characteristics of T-Track® CMV IFN-γ ELISpot assay for the monitoring of CMV-specific CMI were validated in healthy individuals. Results show that stimulation with T-activated® proteins results in improved assay sensitvity and a HLA antigen-independent application. T-Track® CMV demonstrates robust performance in terms of assay variability (≤22%), precision and linearity.
- Barabas S et al. (2017). An optimized IFN-γ ELISpot assay for the sensitive and standardized monitoring of CMV protein-reactive effector cells of cell-mediated immunity. BMC Immunol. 18(1):14.
Validation of T-Track® CMV during pregnancy
“T-Track® CMV can detect impaired CMV-specific cell-mediated immunity during and after pregnancy”
Reuschel E et al. (2017), Functional impairment of CMV-reactive cellular immunity during pregnancy. J. Med. Virol. 89:324–331. doi:10.1002/jmv.24639
The CE-marked T-Track® CMV was cited as a commercially available CMV-specific immune monitoring assay in the international consensus guidelines on the management of CMV in solid-organ transplantation.
- Kotton CN et al. (2013) Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation 96:333–60.