Labcorp Rolls Out First FDA-Approved PTEN Test for Prostate Cancer
Event summary
- Labcorp launched Roche's VENTANA PTEN (SP218) RxDx Assay, the first FDA-approved IHC test for detecting PTEN protein loss in prostate cancer.
- The diagnostic identifies patients eligible for AstraZeneca's TRUQAP (capivasertib) combination therapy.
- Labcorp participated in Roche's early access program to ensure immediate laboratory readiness nationwide.
- Prostate cancer affects over 330,000 new cases annually in the U.S., with PTEN deficiency linked to aggressive progression.
The big picture
Labcorp's launch of the FDA-approved PTEN test underscores the growing importance of biomarker-driven precision oncology. The diagnostic addresses a critical gap in treating aggressive prostate cancer, aligning with broader industry shifts toward personalized medicine. Labcorp's nationwide laboratory network positions it to scale access to this and future companion diagnostics, reinforcing its role as a key player in oncology testing.
What we're watching
- Adoption Pace
- How quickly clinicians integrate the PTEN test into treatment protocols for prostate cancer patients.
- Market Expansion
- Whether Labcorp can leverage this diagnostic to strengthen its position in precision oncology testing.
- Therapeutic Impact
- The effectiveness of AstraZeneca's TRUQAP combination therapy in PTEN-deficient patients over time.
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