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PRAME is found in primary and metastatic melanoma. Immunohistochemical stainings show mostly diffuse positive tumor tissue. Since normal skin is usually negative for PRAME, detection of PRAME protein is useful to determine tumor margin and to differentiate between melanocytic nevi and melanoma.

CE/IVD-labelled clone EPR20330 anti-PRAME: Available at Zytomed Systems!

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).

With the entry into force of the "In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746" on May 26, 2022, the future use of so-called "laboratory developed tests" (LDTs) or in-house IVDs will also be regulated. According to the Article 5(5), LDTs of health institutions must comply with the essential safety and performance requirements set out in Annex I.

Contact us! Within the scope of our IHC workshops, we will be pleased to inform you about the above and further requirements for you as a manufacturer of LDTs.

Your Immunohistochemistry Product Management Team

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.