Research & Development
Roche's VENTANA MMR RxDx Panel receives US FDA label expansion approval
11 August 2022 -

Switzerland-based Roche (SIX: RO, ROG;OTCQX: RHHBY), a biotechnology company, announced on Thursday that it has received approval from the United States Food and Drug Administration (FDA) for a label expansion of the VENTANA MMR RxDx Panel.

The approval advances the firm's commitment to personalised healthcare via tests that determine which patients are most likely to respond to specific and targeted therapies.

The VENTANA MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and who may be eligible for KEYTRUDA (pembrolizumab). The panel is also the first companion diagnostic test to aid in identifying endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR), and who may be eligible for a combination of KEYTRUDA and the tyrosine kinase inhibitor (TKI) LENVIMA (lenvatinib). The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.

FDA approval of the label expansion for the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by IHC. This label expansion follows the April 2021 FDA approval of the VENTANA MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly).

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