A drug is available but unusable. This is the story of the Claudin 18.2 targeted gastric cancer drug Vyloy (zolbetuximab).

This is not the typical situation where a breakthrough drug is approved but is inaccessible due to its high price.

The problem is companion diagnostics (CDx). In order to use a Vyloy, which targets Claudin 18.2, it is essential to first confirm that the patient's tumor is Claudin 18.2 positive.

For this reason, the MFDS approved the companion diagnostic device, VENTANA CLDN18 (43-14A) RxDx Assay from Roche Diagnostics Korea, on the same day that Vyloy was approved.

However, the device’s launch in Korea has been delayed due to the issu