LH · News · 20260805N

Regulatory Approval Milestones

LABCORP HOLDINGS INC. · 2026-08-05 · Importance 38 · Surprise 60

On August 4, 2026, Labcorp announced nationwide availability of Roche’s VENTANA PTEN (SP218) RxDx Assay in the United States. The assay is the first FDA-approved immunohistochemistry companion diagnostic for prostate adenocarcinoma to identify PTEN protein loss. The test supports treatment-selection decisions for patients who may be eligible for AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone acetate and prednisone, expanding Labcorp’s precision-oncology offering.

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