The assay is indicated to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants and may benefit from FDA-approved targeted therapies.
The biomarker showed its strongest diagnostic performance in pulmonary squamous cell carcinoma but also rose in inflammatory lung diseases, underscoring its role as an adjunct rather than a stand‐alone test.
The approval is based on phase 3 PSMAddition results showing reduced risk of disease progression or death with Pluvicto plus standard of care compared with standard of care alone, according to Novartis.
Frequent CLDN18.2 expression was associated with gastric-type differentiation and reduced spread through air spaces in pulmonary invasive mucinous adenocarcinoma.
An ancillary analysis found less than 2-percentage-point differences in 10-year recurrence across margin thresholds, with no statistically significant adjusted association.
According to Agilent Technologies, the expanded indication covers esophageal and gastric tumor types and applies to patients being considered for nivolumab or nivolumab and hyaluronidase-nvhy.
A structured reporting tool improved report completeness, reduced classification errors, and achieved high physician adoption during routine lung cancer pathology reporting.