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Labcorp launches FDA-approved PTEN IHC assay enabling TRUQAP combo selection

Aug 4, 2026, 7:06 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

FDA approval of a companion diagnostic often expands testing volumes and associated services; cross-currents from partner Roche and AstraZeneca could lift LH's diagnostic and oncology testing revenue in the near term.

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Labcorp announced nationwide availability of Roche's VENTANA PTEN (SP218) RxDx Assay, FDA-approved to detect PTEN loss in prostate cancer and guide TRUQAP capivasertib with abiraterone. The test expands precision oncology and could lift Labcorp's oncology testing volumes as biomarker-driven therapies gain adoption.

Labcorp launches FDA-approved VENTANA PTEN RxDx IHC assay.
Assay detects PTEN loss in prostate adenocarcinoma.
PTEN status guides TRUQAP eligibility.
330,000 US prostate cancer cases annually; supports targeted testing.
Roche collaboration enables Day 1 readiness and nationwide deployment.

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