NeoGenomics Launches First FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer
Event summary
- NeoGenomics launched PTEN IHC CDx, the first FDA-approved immunohistochemistry companion diagnostic for prostate adenocarcinoma.
- The test identifies PTEN protein loss to determine eligibility for AstraZeneca’s TRUQAP® (capivasertib) therapy.
- PTEN IHC CDx is available as a standalone order or integrated into NEO PanTracer™ Pro, a comprehensive molecular workup.
- Approximately 8,750 U.S. patients annually with metastatic prostate cancer may benefit from this diagnostic.
The big picture
The launch of PTEN IHC CDx positions NeoGenomics as a key player in precision oncology for prostate cancer, aligning with the broader shift toward targeted therapies. With over 300,000 new prostate cancer cases annually in the U.S., this diagnostic could significantly influence treatment strategies for a subset of patients with aggressive disease forms.
What we're watching
- Market Adoption
- How quickly community oncology practices will integrate PTEN IHC CDx into treatment workflows.
- Therapeutic Impact
- Whether the diagnostic will expand access to TRUQAP® and improve outcomes for PTEN-deficient prostate cancer patients.
- Competitive Positioning
- NeoGenomics' ability to sustain leadership in urologic oncology diagnostics amid potential competitor responses.
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