Our size is microscopic

PRAME (PReferentially-expressed Antigen in MElanoma) was first described in a paper by Ikeda et al., through analysis of the specificity of tumor-reactive T-cell clones derived from a patient with metastatic cutaneous melanoma. [1, 2]

As a manufacturer and distributor of in vitro diagnostics, our enterprise group with the companies Zytomed Systems GmbH and ZytoVision GmbH attaches great importance to the timely implementation of the requirements of the IVDR (Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5th 2017 on in vitro diagnostic medical devices).

The IVDR, in force since May 26, 2022, represents a turning point in the EU-wide harmonization of patient safety. At the same time, it places high demands on us as manufacturers and on you as a user of in vitro diagnostic medical devices to implement the new regulation. We would like to meet this challenge together with you for the benefit of your patients. It is important to us to certify our portfolio of diagnostic solutions in compliance with the IVDR in due time. Therefore, we would like to keep you informed about our progress with the implementation of the IVDR.

A recently conducted study has shown that TRPS1 is expressed very highly in triple-negative breast cancer (TNBC). Expression was significantly higher than the GATA3 expression in metaplastic (85% vs. 21%) and non-metaplastic (86% vs. 51%) TNBC. Accordingly, TRPS1 has proven to be a highly specific and sensitive marker for all types of breast cancer, in particular TNBC. (Di Ai et al.; "TRPS1: a highly sensitive and specific marker for breast carcinoma, especially for triple-negative breast cancer. Mod Pathol 34: 710-719, 2021)

Recently, a second ZytoDot ^® 2C probe for detecting rearrangements of the NTRK genes has become available: the new ZytoDot ^® 2C SPEC NTRK3 Break Apart Probe (C-3079-100). Together with the already existing ZytoDot ^® 2C SPEC NTRK1 Break Apart Probe (C-3078-100), a large range of NTRK rearrangements can be covered now. Both probes are designed for the qualitative detection of NTRK3 and NTRK1 rearrangements in FFPE tissue using the ZytoDot ^® 2C CISH implementation Kit.