Labcorp Launches First FDA-Approved PTEN Companion Diagnostic for Prostate Cancer

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Summary · why it matters

Labcorp announced the nationwide availability of Roche's VENTANA PTEN (SP218) RxDx Assay, the first FDA-approved immunohistochemistry companion diagnostic to detect PTEN protein loss in prostate adenocarcinoma tumors. The assay helps identify patients who may be eligible for treatment with AstraZeneca's TRUQAP in combination with abiraterone acetate and prednisone. PTEN loss is associated with more aggressive disease and reduced benefit from standard therapies, and until now no approved treatments specifically targeted this biology. Labcorp participated in Roche's early access program to ensure Day 1 laboratory readiness, and the test is now available through Labcorp's national network, complementing its comprehensive oncology testing portfolio.

Impact on assets 3

Biotech & Genomic Medicine▲
Laboratory Corporation of America Holdings
LH
▲ PositiveDemandrelevance

Labcorp launches first FDA-approved PTEN companion diagnostic, expanding its oncology testing portfolio and potentially increasing demand for its services.

AstraZeneca PLC
AZN
▲ PositiveDemandrelevance

The companion diagnostic helps identify patients eligible for AstraZeneca's TRUQAP combination therapy, potentially expanding its market.

Health Care▲
Roche Holding AG
ROP
▲ PositiveDemandrelevance

Same as Roche Holding AG Participation: assay availability through Labcorp may boost sales.

Theme Impact 1

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