Roche’s VENTANA CLDN18 (43-14A) RxDx Assay has received CE Mark approval for use as an aid in identifying patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The certification allows eligible patients to receive treatment with Astellas’ targeted therapy VYLOY (zolbetuximab).
Current clinical guidelines for gastric and GEJ cancer recommend the use of biomarkers to guide therapeutic decisions. The VENTANA CLDN18 (43-14A) RxDx Assay assists clinicians in determining the CLDN18.2 status of tumours and assessing whether patients may benefit from CLDN18.2-targeted therapy.
VYLOY is the first approved treatment that targets CLDN18.2-positive gastric and GEJ cancer, providing additional treatment options for these patients.
Roche Diagnostics CEO Matt Sause said: “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 VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical assay intended to assess Claudin 18 (CLDN18) protein expression in gastric adenocarcinoma, including gastroesophageal junction adenocarcinoma.
It uses the OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument. Roche’s test measures the expression of both variants of the CLDN18 protein (18.1 and 18.2 isoforms), with CLDN18.2 being the predominant variant in gastric and GEJ cancers.
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on findings from the SPOTLIGHT and GLOW clinical trials, where the assay was used to enrol patients whose tumours were CLDN18.2 positive.
CLDN18.2 positivity was defined as having at least 75% of tumour cells displaying moderate to strong membrane CLDN18 staining, as measured by the assay. In these studies, around 38% of patients with gastric or GEJ cancer expressed high levels of CLDN18, qualifying them as CLDN18.2 positive.
Patients treated with a combination of zolbetuximab and chemotherapy experienced a reduction of 25-31% in disease progression or death.
Recently, Roche introduced the cobas Respiratory Flex test, which utilises the company’s proprietary Temperature-Activated Generation of Signal (TAGS) technology. Developed by Roche scientists, TAGS technology combines multiplex polymerase chain reaction (PCR) testing with integrated colour, temperature, and data analysis to detect up to 15 pathogens in a single PCR test.
