Roche has received approval through the EU’s In Vitro diagnostic regulation for several label expansions of its companion diagnostic platform that can identify a cancer patient's mismatch repair (MMR) status.
The approvals are for the drug giant’s Ventana MMR RxDx panel, an immunohistochemistry (IHC) companion diagnostic test that scans a patient’s genetic code.
The test then evaluates a panel of MMR proteins in tumor that clinicians use for treatment decisions, the company said in a June 11 press release.
MMR occurs naturally as a mechanism that scans a person’s DNA, correcting errors that cause disease. When MMR is deficient, cells mutate, which can lead to cancer.
“By providing a standardized testing option for mismatch repair status with our Ventana MMR RxDx panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types,” Laura Apitz, Roche’s head of pathology, said in a statement.
The upgraded platform is currently available in countries covered by the EU’s in vitro regulatory as a companion to Merck & Co.’s Keytruda, AstraZeneca’s Imfinzi and Imfinzi combined with Lynparza, and GSK’s Jemperli.
In April 2025, Roche earned a breakthrough designation from the FDA for its Ventana TROP2 RxDx device, which combines an antibody assay with artificial-intelligence-powered analysis to provide what the company touted as the regulatory agency’s first AI-driven companion diagnostic for non-small cell lung cancer.
The companion diagnostic test was designed to identify patients with advanced or metastatic NSCLC who may benefit from treatment with Datroway (datopotamab deruxtecan-dlnk), an ADC developed by AstraZeneca and Daiichi Sankyo.