Berlin, 08 July 2020 Epimune today completed CE-marking of its first in vitro diagnostic (IVD) test, the i.Mune TBNK Test, with the signing of the declaration of conformity and registration with the German Institute for Medical Documentation and Information (DIMDI). This is another milestone in the short history of our company, which started operations in April 2019.
With our i.Mune TBNK test our customers can determine the number of lymphocytes (CD3+, CD4+, CD8+ T cells, B cells and Natural Killer Cells) from a drop of blood. The counting of T-/B- and NK-lymphocytes is usually done after a conspicuous complete blood cell count (CBC) and is crucial for the early detection and monitoring of patients with immune cell disorders including congenital immune defects. For example, in HIV infection, autoimmunity, cancer, or during immunosuppressive therapies.
The test has successfully completed all necessary studies and is manufactured in our facilities in Berlin. In the last of these studies, the so-called performance evaluation test, we were able to show with prospectively collected samples from healthy donors that the results of our test correlate very well with the standard method, flow cytometry.
The i.Mune TBNK test can be performed in any laboratory with molecular diagnostic equipment. The high reproducibility and standardization of the i.Mune TBNK test allows direct comparison of results obtained in different laboratories.
With a positive decision from DIMDI, which we expect shortly, we can start commercializing the test to immunological centers and reference laboratories. Over the next few weeks we will also validate the test for dried blood spot (DBS) samples, so that there are no longer any logistical limits to the collection of sample material - neither in terms of space nor time.