New FISH probe ZytoLight SPEC NECTIN4/1p12 Dual Color

We are happy to announce the launch of the next and highly promising ZytoLight^® FISH probe:

ZytoLight SPEC NECTIN4/1p12 Dual Color Probe (Prod. No. Z-2331-50/-200).

The intended purpose of this probe is the qualitative detection of amplifications involving the human NECTIN4 gene as well as the detection of chromosome 1p12 specific sequences in formalin-fixed, paraffin-embedded specimens by fluorescence in situ hybridization (FISH).

This probe is an in vitro diagnostic medical device according to IVDR (EU) 2017/746.

Amplifications of the NECTIN4 gene are found in numerous solid tumors, most frequently in bladder cancer (17%; approximately 25% in metastatic urothelial carcinomas), cholangiocarcinomas (14%), and hepatocellular carcinomas (12%). NECTIN4 amplifications also occur in very common tumor types such as breast cancer and lung adenocarcinomas, with frequencies of 9% and 7%, respectively.

In 2019, the U.S. FDA approved the anti-Nectin-4 antibody-drug conjugate enfortumab vedotin for patients with metastatic urothelial carcinoma; the EMA followed with approval in the EU three years later. NECTIN4 amplification serves as a biomarker with high predictive value (response rate > 90%) for responsiveness to enfortumab vedotin.

Currently, Nectin-4 is also being discussed as a potential prognostic biomarker and/or therapeutic target for breast cancer, lung cancer, and various other solid tumors, and is being analyzed in a number of clinical studies.

ZytoVision is the first company to launch an IVDR FISH probe for the detection of NECTIN4 amplifications!