Code
APH-PTFD-01AX
Test
Active-Compendium
88342 x 1 or 88341 x 1; 88360 x 1
Clinical
Pathology
<strong>Preferred specimen (FFPE block):</strong><br>
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<strong>If submitting slides (instead of a block):</strong><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
H&E slide: One (1) unbaked, unstained slide for H&E staining (required)<br>
Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered<br>
<strong>Specimen identification:</strong><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<strong>If submitting slides (instead of a block):</strong><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
H&E slide: One (1) unbaked, unstained slide for H&E staining (required)<br>
Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered<br>
<strong>Specimen identification:</strong><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Flag Active
True
Orderable Test Description
<p>PTEN FDA for Prostate Carcinoma is an FDA approved qualitative IHC assay indicated as an aid in identifying patients with prostate carcinoma whose tumors demonstrate PTEN loss, as determined by an FDA-approved test, for treatment with TRUQAP® (capivasertib). The assay is performed using the Ventana BenchMark ULTRA instrument with the OptiView DAB IHC Detection Kit and associated ancillary reagents.<br><br>
Methodology: <br>
PTEN protein expression is assessed in viable tumor cells using a rabbit monoclonal anti-PTEN antibody (clone SP218). PTEN status is evaluated based on cytoplasmic staining, with or without membranous staining.<br><br>
Scoring and interpretation:<br>Tumors are considered PTEN positive (loss) if ≥90% of viable tumor cells show absence of cytoplasmic staining.<br>
Tumors are considered PTEN negative (no loss) if <90% of viable tumor cells show cytoplasmic staining.</p>
Methodology: <br>
PTEN protein expression is assessed in viable tumor cells using a rabbit monoclonal anti-PTEN antibody (clone SP218). PTEN status is evaluated based on cytoplasmic staining, with or without membranous staining.<br><br>
Scoring and interpretation:<br>Tumors are considered PTEN positive (loss) if ≥90% of viable tumor cells show absence of cytoplasmic staining.<br>
Tumors are considered PTEN negative (no loss) if <90% of viable tumor cells show cytoplasmic staining.</p>
Orderable Turn Around Time
1-2 Days
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PTEN"]}}
Keywords string
PTEN, PTEN FDA, Protein Tyrosine Phosphatase, PTEN IHC, PTEN Expression PTEN FDA for Prostate Carcinoma
Title URL
pten-fda-for-prostate-carcinoma
TAT Details
Global: 2 Days
Tech-Only (stain only): 24 Hours
Storage and transportation
Slides may be stored at room temperature; transport with cold pack, making sure cold pack is not in direct contact with specimen.
NYS Clients: Please provide Date and Time of Collection.