LH · News · 20260804N

Regulatory Approval Milestones

LABCORP HOLDINGS INC. · 2026-08-04 · 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.

Key facts

• The VENTANA PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration to determine PTEN protein loss in tumors of patients with prostate adenocarcinoma. source