Code
APH-PGGP-01AX
Test
Active-Compendium
88360x1
Clinical
Oncology,Pathology
<b>Preferred specimen (FFPE block):</b><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>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>Specimen identification:</b><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>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>Specimen identification:</b><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>PD-L1 IHC 28-8 pharmDx (PD-L1 28-8 CDx for Gastric/Esophageal) is a qualitative immunohistochemical assay using monoclonal rabbit anti-PD-L1, clone 28-8, intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) gastric carcinoma, gastroesophageal junction (GEJ) carcinoma, esophageal adenocarcinoma (EAC), and esophageal squamous cell carcinoma (ESCC) tissues using the EnVision FLEX visualization system on Autostainer Link 48.<br><br>On July 14, 2026, the FDA approved PD-L1 IHC 28-8 pharmDx (Code SK005) as a companion diagnostic to identify patients with Gastric, GEJ, EAC, and ESCC whose tumors express PD-L1 (CPS ≥1) and who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase-nvhy). Tissues with a PD-L1 Combined Positive Score (CPS) ≥1 are considered to have PD-L1 expression.<br><br>Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer's online interpretation training. All PD-L1 28-8 IHC test options may be viewed <a href="https://www.neogenomics.com/providers/test-search?tm_X3b_und_aggregated_field=" target="_blank" rel="noopener">here</a>.</p>
Orderable Turn Around Time
1-2 Days
Keywords
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}
Keywords string
PDL1, gastric cancer, GC, gastroesophageal junction carcinoma, GEJ, esophageal adenocarcinoma, EAC, PD1, PD L1, PD-L1, CDx, cdx PD-L1 28-8 CDx for Gastric/Esophageal
Title URL
pd-l1-28-8-cdx-for-gastric-esophageal
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.