Roche receives FDA approval for diagnostic test Ventana CLDN18

Roche receives FDA approval for Ventana CLDN18, a diagnostic test for targeted treatment of stomach and esophageal cancer.

10/21/2024, 4:22 PM
Eulerpool News Oct 21, 2024, 4:22 PM

The Swiss pharmaceutical company Roche has received approval from the US health authority FDA for its companion diagnostic Ventana CLDN18.

With this test, tumors in patients with stomach and esophageal cancer can be identified that are suitable for treatment with the drug Vyloy from the Japanese manufacturer Astellas.

Patients with stomach or esophageal cancer are often diagnosed at an advanced stage," explained Roche in a statement on Friday evening.

The diagnostic tool makes it possible to specifically identify patients for specific therapies and offer them additional treatment options.

Already a week ago, Roche had received CE certification for Ventana CLDN18 from the EU authorities.

According to company information, stomach cancer is the fifth most common cancer and the fourth leading cause of cancer-related deaths worldwide.

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