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The recommendations are a consensus of the AMP, CAP, Clinical Pharmacogenetics Implementation Consortium, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmaco­genomics Knowledgebase.

The full article is available at https://bit.ly/TPMT-NUDT15.

Rapid AST system receives breakthrough device designation

The Food and Drug Administration has granted its breakthrough device designation for the Specific Reveal Rapid Antimicrobial Susceptibility Test (AST) System. The system was developed by Specific Diagnostics, which was acquired by BioMérieux in May. It provides phenotypic antibiotic susceptibility test results in an average of 5.5 hours from availability of a positive blood culture.

“Specific Reveal is perfectly aligned with BioMérieux’s priority to provide innovative diagnostics to support antimicrobial stewardship,” Pierre Boulud, chief operating officer, clinical operations, BioMérieux, said in an Aug. 22 news release.

FDA approves CDx to identify dMMR solid tumor patients for anti-PD-1 immunotherapy

Roche announced Food and Drug Administration approval of a label expansion for the Ventana MMR RxDx Panel. It is the first immunohistochemistry companion diagnostic to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair (dMMR) and who may be eligible for Keytruda (pembrolizumab).

The panel is also the first companion diagnostic to aid in identifying endometrial cancer patients whose tumors are proficient in DNA mismatch repair (pMMR) and who may be eligible for a combination of Keytruda and tyrosine kinase inhibitor Lenvima (lenvatinib).

The 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-PD-1 immunotherapy Jemperli (dostarlimab-gxly). That approval was expanded for the following indications: dMMR solid tumor patients for treatment with Jemperli (August 2021), dMMR solid tumor patients for treatment with Keytruda (March 2022), and pMMR solid tumor patients for treatment with a combination of Keytruda and Lenvima (June 2022).