Ultra-sensitive test for Epstein-Barr virus to monitor patients after organ transplantation to prevent rejection

Purpose and goal

** Denna text är maskinöversatt ** The aim of the project was to develop and validate a sensitive test for EBV infection in transplant patients with protected technology and to establish partnerships prior to IVD registration and launch. Assayer for such a test based on the protected technology Two-tailed RT-qPCR has been developed and a technical validation has been performed. The validation of clinical trials will need to be completed after the end of the project. A future test is planned to be licensed to external partners.

Expected results and effects

** Denna text är maskinöversatt ** Assays have been developed for 44 EBV microRNAs based on two-tailed RT-qPCR. An evaluation of retrospective clinical trials to determine which of these markers are suitable candidates for a panel. An extended technical validation has then been performed by the selected assays and a first test is designed. This test has then been evaluated on cell cultures and in blood samples and any updates will be implemented in a second version of the test. Assays based on a technology with built-in barcodes have also been evaluated with good results.

Planned approach and implementation

** Denna text är maskinöversatt ** The project has been implemented as a collaboration between three parties, a collaboration that has worked very well. However, all three parties have been severely affected by the Covid-19 pandemic, which has delayed the validation work in particular. Despite this, the project has managed to produce a first version of a test, generate results as a basis for a future commercial test, prepare for future validation and establish contacts with potential licensees.