Test 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 | ||
Reject Due To
| Decalcified paraffin embedded tissue | Reject |
| Wet/frozen tissue | Reject |
| Cytology smears | Reject |
| Noncharged slides | Reject |
| ProbeOn slides | Reject |
| Snowcoat slides | Reject |
| Nonformalin fixed tissue, including CytoLyt, SurePath, alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER and zinc formalin fixatives | Reject |
| Nonparaffin embedded tissue | Reject |
| Broken or cracked unstained slides | Reject |
Clinical Information
The PTEN (SP218) RxDx Assay is indicated as a companion diagnostic to detect and select PTEN-deficient invasive prostate carcinoma patients who may potentially benefit from a combination treatment with capivasertib (TRUQAP).
Clinical cutoff for PTEN loss is greater than or equal to 90% of viable malignant cells with no specific cytoplasmic expression.
Reference Values
An interpretive report will be provided.
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysSpecimen Retention Time
Until reportedPerforming 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 |