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HelpTest Code PTENC PTEN (SP218), Semi-Quantitative Immunohistochemistry, Manual
Shipping Instructions
Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.
Necessary Information
A pathology/diagnostic report and a brief history are required.
Specimen Required
Specimen Type: Tissue
Supplies: Pathology Packaging Kit (T554)
Submit:
Formalin-fixed, paraffin-embedded tissue block
OR
3 Unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Additional Information: One slide will be stained with hematoxylin and eosin and returned.
Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.
Useful For
Aiding in detecting PTEN-deficient invasive prostate adenocarcinoma
Method Name
Immunohistochemistry (IHC)
Reporting Name
PTEN (SP218), SemiQuant IHC, ManualSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Special | Ambient (preferred) | |
| Refrigerated | ||
Reference Values
An interpretive report will be provided.
Interpretation
The PTEN protein is localized in the cytoplasm and nucleus, and is an essential enzyme expressed in several non-neoplastic tissues. The PTEN (SP218) RxDx Assay is indicated as a companion diagnostic to aid in identifying patients who may be eligible for treatment with TRUQAP (capivasertib). Clinical cutoff for PTEN loss is greater than or equal to 90% of viable malignant cells with no specific cytoplasmic expression. Nuclear expression in viable malignant cells should be disregarded.(1)
Clinical Reference
1. Ventana PTEN (SP218) RxDx Assay Data Sheet. Roche Diagnostics; 1019742US, 02/01/2026
2. Jamaspishvili T, Berman DM, Ross AE, et al. Clinical implications of PTEN loss in prostate cancer. Nat Rev Urol. 2018;15(4):222-234
3. Shah RB, Shore KT, Yoon J, Mendrinos S, McKenney JK, Tian W. PTEN loss in prostatic adenocarcinoma correlates with specific adverse histologic features (intraductal carcinoma, cribriform gleason pattern 4 and stromogenic carcinoma). Prostate. 2019;79(11):1267-1273
4. 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
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88360
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| PTENC | PTEN (SP218), SemiQuant IHC, Manual | 81706-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 624278 | Interpretation | 59465-5 |
| 624287 | Participated in the Interpretation | No LOINC Needed |
| 624288 | Report electronically signed by | 19139-5 |
| 624289 | Material Received | 81178-6 |
| 624290 | Disclaimer | 62364-5 |
| 624291 | Case Number | 80398-1 |