PTEN FDA for Prostate Carcinoma is now available to support precision oncology in metastatic hormone-sensitive prostate cancer (mHSPC). This immunohistochemistry (IHC) companion diagnostic assay helps identify patients with PTEN deficiency who may benefit from a new targeted therapy, supporting biomarker-driven treatment decisions when it matters most.
A quarter of advanced prostate cancer patients exhibit PTEN deficiency, an aggressive subtype linked to worse outcomes and historically limited targeted treatment options.1 Early identification of this high-risk population enables more informed, biomarker-guided therapy selection earlier in the treatment pathway.
Testing is available as:
A standalone PTEN FDA companion diagnostic assay
As part of PanTracer™ Pro, which combines comprehensive genomic profiling (CGP) with cancer-type directed IHC testing for broad genomic insights in one streamlined solution.
PTEN Laboratory Developed Test (LDT) broadening testing utility across diverse clinical scenarios.
Ordering information:
Updated test requisition forms are available here.
Updates to our PTEN LDT, including a new clone and scoring algorithm, are coming soon.
To support timely, accurate patient care, we will make every effort to identify prostate cancer patients and convert PTEN orders on older requisition forms to PTEN FDA for Prostate Carcinoma (CDx) when appropriate.
To avoid delays and ensure clear test intent, please discontinue use of requisition forms that do not list both PTEN LDT and PTEN FDA for Prostate Carcinoma (CDx). Using the most current requisition helps ensure the correct test is ordered and processed efficiently.
As a trusted leader in oncology diagnostics, NeoGenomics is committed to delivering clinically actionable diagnostics that align with evolving biomarker-driven care pathways, ensuring your reports provide the precision oncology insights that treating clinicians need at the point of care.
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016/j.annonc.2025.10.004