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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, Manual

Specimen Type

Special

Specimen 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 days

Specimen Retention Time

Until reported

Performing 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