Medical Device Network

Roche’s VENTANA CLDN18 assay gains CE mark

The qualitative test assesses Claudin 18 protein expression in gastric adenocarcinoma.

Roche has gained the Conformité Européenne (CE) mark of approval for its VENTANA CLDN18 (43-14A) RxDx assay to identify patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma eligible for targeted therapy with Astellas’ VYLOY (zolbetuximab).

The approval introduces the first immunohistochemistry (IHC) companion diagnostic test to determine Claudin 18 (CLDN18) protein expression in tumours.

Gastric cancer, the fifth most common cancer globally, poses a significant challenge due to late diagnosis and has a low survival rate in the European Union (EU).

The assay's ability to determine CLDN18.2 status is pivotal for clinicians to identify patients who may benefit from CLDN18.2 targeted therapy, such as VYLOY.

VYLOY is the first approved treatment targeting CLDN18.2-positive gastric/GEJ cancer in particular.

VENTANA is a qualitative test used in the assessment of the protein expression in gastric adenocarcinoma, including GEJ adenocarcinoma.

The test measures both CLDN18.1 and CLDN18.2 isoforms and aids in identifying patients who may be eligible for treatment with VYLOY.

Roche Diagnostics CEO Matt Sause stated: “Gastric cancer remains a significant global health challenge. In Europe, only three percent of patients with metastatic disease live beyond five years.

“Our new companion diagnostic is a significant step forward for patients. By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities, and aid clinicians to potentially improve outcomes.”

The CE mark is based on the SPOTLIGHT and GLOW clinical trials, where it served as the enrolment assay.

38% of gastric/GEJ cancer patients expressed high CLDN18 levels and were considered CLDN18.2 positive by the assay.

When treated with a combination of zolbetuximab and chemotherapy, these patients experienced a significant reduction in disease progression or mortality.

Roche introduced the cobas Respiratory flex test in September 2024, leveraging the company's temperature-activated generation of signal technology for diagnostics.