Anti-CD38 antibodies like Daratumumab, Felzartamab, and Isatuximab are an emerging line of new therapeutics for the treatment of multiple myeloma and other cancers. They can lead to a strong interference in indirect antiglobulin tests (IAT) and are a major and increasing challenge for immunohematology laboratories.
Imusyn has developed a new and patented reagent which can overcome anti-CD38 antibody interference in one, simple step. It inhibits the agglutination effect of Daratumumab, Felzartamab, and Isatuximab specifically, without affecting other anti-erythrocyte antibodies like anti-Kell, thus eliminating the need to pre-select donors for compatibility testing.
Imusyn’s proprietary technology masks the CD38 on the surface of the red blood cells (Antigen-masking IAT, AMIAT). The primary component of DaraEx plus is an anti-CD38 antibody without a human Fc region. When treating red blood cells (RBC) with DaraEx plus, the antibody binds CD38, thus covering the epitope of Daratumumab, Felzartamab, and Isatuximab. The DaraEx plus-treated RBC will behave as if no anti-CD38 antibody was present in the sample.
The Instructions for Use (IFU) are available for download here.
DaraEx plus (CE marked IVD) and DaraEx (RUO) can be ordered from our distribution partner inno-train Diagnostik GmbH ⧉.