https://pdl1.gilbertbigras.com/ 2026-07-06T19:51:57+00:00 https://pdl1.gilbertbigras.com/ https://pdl1.gilbertbigras.com/lib/exe/fetch.php?media=wiki:dokuwiki.svg text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=analyticalissues&rev=1738454443&do=diff Possible Analytical Issues Special instrument requirement might influence the quality of the assay Intense DAB Background can make the PDL1 interpretation difficult. Severe background should not be interpreted. Manufacturer has recommended to maintain high level of humidity within the instrument. We have achieved optimal results in the EZIHC lab by sealing the instrument and by adding boiling water within the instrument (see results below) text/html 2026-04-08T04:35:57+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=biomarkers_smart_phrases&rev=1775622957&do=diff BIOMARKERS with Identifiers (Test:ID) Breast Biomarkers Biomarker Assay Purpose Drug(s) Diagnostic Test Test ID PD-L1 Triple Negative Breast Cancer (TNBC) Pembrolizumab PDL1 Dako 22C3 PharmDX PDL1TNBC22C3PEMBRO Gastrointestinal Biomarkers Biomarker Assay Purpose text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=blueprint2&rev=1738454443&do=diff Blue Print Study phase 2 Blue Print Study Phase 2 text/html 2026-04-08T00:27:10+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=bmclaudin18&rev=1775608030&do=diff CLAUDIN 18.2 IHC BIOMARKER Assay Purpose: Diagnostic : gastric or gastroesophageal junction (GEJ) adenocarcinoma Drug: Zolbetuximab Diagnostic test: CLDN18.2 Immunohistochemistry (IHC), VENTANA CLDN18 (43-14A) RxDx assay Performed on block *** text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=calgaryteam&rev=1738454443&do=diff text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=cellular_immunity&rev=1738454443&do=diff Adaptive cellular immunity triggered by "foreign" antigens (virus, cancer, etc.) PDL1 Expression by Trophoblastic cells protects from maternal rejection Human trophoblastic cells display many of the features of malignant cells such as cellular growth and their ability to invade normal tissue including blood vessels and are apparently not eradicated by the host immune system. These trophoblastic cells are genetically significantly different from the mother and should initiate a maternal immun… text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=clinicaltrial&rev=1738454443&do=diff text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=edmontonteam&rev=1738454443&do=diff text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=falsepdl1results&rev=1738454443&do=diff Link between false PDL1 results and biopsy size Intrinsic anomaly vs Adaptative expression (PDL1 expression is spatially and temporarily heterogeneous) ---------- 426 NSCLC Alberta 2017 Size Sample Histogram ---------- 426 NSCLC Alberta 2017 Size Sample Histogram ZOOM on the smallest samples text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=ioresponsepredictors&rev=1738454443&do=diff Predictors of response to immunotherapy Tumoural PDL1 expression, the number of lymphocytes within the tumoural bed (TILs) and the mutational load are the three major predictors. Of interest smokers are usually good responder to immunotherapy because their associated NSCLC have high mutational load thank to tobacco usage. Colon cancer with abnormal MMRs also have high mutational load and respond well to immunotherapy. Patients pre-treated with radiotherapy have better response to immunotherapy … text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=keynote001&rev=1738454443&do=diff The 2015 KEYNOTE-001 clinical trial for the Treatment of NSCLC using Pembrolizumab <https://www.nejm.org/doi/full/10.1056/nejmoa1501824> The 2015 KEYNOTE-001 Adverse Effects text/html 2026-04-08T04:12:58+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=lualknew.docx&rev=1775621578&do=diff ALK IHC (OTI1A4) result: Positive OR Negative OR Equivocal Performed on block: *** If the result is insufficient, the immunostain was not performed: please submit if possible a new sample. If the result is negative, it supports absence of ALK gene rearrangement. If the result is text/html 2025-02-21T16:47:32+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=lung&rev=1740156452&do=diff Assay Purpose: Diagnostic : Non-small cell lung carcinoma Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result: Positive TPS >= 50% Interpretation: Tumour Percentage Score (TPS) - Negative (< 1%), Low expression (1-49%), Positive (>= 50%) text/html 2026-04-08T04:31:01+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=mdhpdl1nonreportable&rev=1775622661&do=diff PD-L1 IHC BIOMARKER – NON-REPORTABLE Comment: PD-L1 was requested; however, the result is Non-Reportable for the following reason(s): * Fixation Requirements: Validated only for tissue fixed in 10% NBF for 12–72 hours. * Cellularity: Sample lacks the minimum requirement of text/html 2026-04-08T03:36:21+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=molarcep17.docx&rev=1775619381&do=diff CEP17 SISH Ploidy Analysis Result: DIPLOID Original block *** results: Number of Nuclei Counted 50 Average Number of Signals per Nucleus *** Percentage of Nuclei with three signals*** % Interpretation: A diploid DNA content is most frequently associated with a hydropic abortus. Diploidy can also be associated with a complete hydatidiform molar pregnancy. Correlation with clinical findings and morphology is recommended. text/html 2026-04-08T04:21:14+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pantrk&rev=1775622074&do=diff BIOMARKER RESULTS (IHC) Original block: panTRK IHC result: Positive OR Negative ProportionStain intensitySubtotalNuclear staining {0 to 3} {0 to 2} {} Cytoplasmic staining{0 to 3} {0 to 2} {} Membranous staining text/html 2026-04-08T03:33:49+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1cervix&rev=1775619229&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Uterine cervical cancer (SCC and Adenocarcinoma) Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result:       Positive CPS >= 1 OR Negative CPS < 1 OR Inadequate Performed on block text/html 2026-04-08T03:48:08+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1hnscc22c3pembro.docx&rev=1775620088&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Lung Non Small Cell Carcinoma Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result:       Positive TPS >= 50% OR Low expression TPS >= 1% < 50% OR Negative TPS < 1% text/html 2026-04-08T03:48:49+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1hnsccneoadpembro.docx&rev=1775620129&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) – Neoadjuvant/Adjuvant Treatment Setting Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result:       Positive CPS >= 1 text/html 2026-04-08T03:52:05+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1nsclcatezosp263.docx&rev=1775620325&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Lung Non Small Cell Carcinoma stage II to IIIA Drug: Atezolizumab (Roche) as adjuvant therapy Diagnostic test: PDL1 SP263 Result:       Positive TPS >= 50% OR Negative TPS < 50% OR Inadequate text/html 2026-04-08T03:46:42+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1nsclcpembro22c3.docx&rev=1775620002&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Lung Non Small Cell Carcinoma Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result:       Positive TPS >= 50% OR Low expression TPS >= 1% < 50% OR Negative TPS < 1% text/html 2026-04-08T03:47:20+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1tnbc22c3pembro&rev=1775620040&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnostic : Triple Negative Breast Cancer Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result:       Positive CPS >= 10 , OR Negative CPS < 10 or Inadequate Interpretation: Combined Proportion Score ( text/html 2026-04-08T03:47:45+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=pdl1uppergimarch2026&rev=1775620065&do=diff PD-L1 IHC BIOMARKER Assay Purpose: Diagnosis: Gastric, gastroesophageal, and esophageal adenocarcinoma, and esophageal squamous cell carcinoma Drugs: Pembrolizumab (Merck) and Nivolumab (Bristol Myers Squibb) Diagnostic test: PDL1 Dako 22C3 PharmDX text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=preanalytical&rev=1738454443&do=diff Pre-analytical tissue requirements for PDL1 testing * Tissue fixed in 10% neutral buffered formalin (NBF) * Fixation time: 12 to 72 hours * Not validated with other type of fixative * Not validated with tissue treated with microwaves * Not validated with tissue treated for decalcification text/html 2026-04-08T04:05:42+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=start&rev=1775621142&do=diff BIOMARKERS (with focus on PDL1) Biomarkers Smart Phrases What is PDL1? Programmed death-ligand 1 is a protein that in humans is encoded by the CD274 gene. It is a transmembrane protein that suppresses the cellular immunity during particular events such as physiological event like pregnancy, physiopathological event like protecting normal cells in context of infection/inflammation and to prevent autoimmune disease. Cellular immunity is most effective against cells infected with viruses, intrac… text/html 2026-04-08T04:39:52+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=summary_list&rev=1775623192&do=diff Code Test Name Specimen / Site PDL1UPPERGIMARCH2026 PD-L1 IHC BIOMARKER Stomach PDL1HNSCC22C3PEMBRO PD-L1 IHC BIOMARKER Advanced H&N PDL1CERVIX PD-L1 IHC BIOMARKER Cervix Uterus PDL1HNSCCNEOADPEMBRO PD-L1 IHC BIOMARKER Resectable H&N PDL1NSCLCATEZOSP263 text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=templatecervicalcancer&rev=1738454443&do=diff Report template for the 3D application: Cervical Cancer (SCC and Adeno)/Pembrolizumab/Dako PD-L1 IHC 22C3 pharmDx PD-L1 IHC (22C3 pharm Dx) result:       {*Positive [CPS >= 1] OR Negative CPS < 1 OR Inadequate} Interpretation: Combined Positive Score (CPS) - Negative (< 1), *Positive (>= 1) text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=templateh_n&rev=1738454443&do=diff Assay Purpose: Diagnostic : Head and neck squamous cell carcinoma Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result: {*Positive [CPS >= 1 and < 20] OR *Positive [CPS >= 20] OR Negative CPS < 1 OR Inadequate} Interpretation text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=templatensclc&rev=1738454443&do=diff Assay Purpose: Diagnostic : Non-small cell lung carcinoma Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result: Positive TPS >= 50% Interpretation: Tumour Percentage Score (TPS) - Negative (< 1%), Low expression (1-49%), Positive (>= 50%) text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=templatetnbc&rev=1738454443&do=diff Assay Purpose: Diagnostic : Triple Negative Breast Cancer Drug: Pembrolizumab (Merck) Diagnostic test: PDL1 Dako 22C3 pharmDX Result: Negative CPS < 10 Interpretation: Combined Positive Score (CPS) - Negative (< 10), *Positive (>= 10) Batch control: Adequate; on slide controls: Adequate Disclaimer: indication: adult patients in combination with chemotherapy with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for… text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=templateuppergiadeno&rev=1738454443&do=diff Assay Purpose: Diagnostic : Gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma Drug: Nivolumab (Bristol Myers Squibb) Diagnostic test: PDL1 Dako 28-8 pharmDX Result: Positive CPS >= 5 Interpretation: Combined Positive Score (CPS text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=tissuetype&rev=1738454443&do=diff Type of tissue for PDL1 readout Metastasis or primary tumour? The first studies applied to NSCLC did not show significant difference between the primary and the metastatic sites. Initial recommendations were to utilize what is available. However, a 2020 text/html 2025-02-02T00:00:43+00:00 Anonymous (anonymous@undisclosed.example.com) https://pdl1.gilbertbigras.com/doku.php?id=tps-cps&rev=1738454443&do=diff Tumour Proportion Score (TPS) and Combined Proportion Score (CPS) TPS is the proportion or percentage of positive tumoral cells. The staining must be membranous. It can be partial or complete and can be of weak, moderate or strong intensity. Mainly used for NSCLC, immune cells are not taken in account and sometimes make the assessment difficult. Indeed macrophages can mimic low-grade tumoural cells. TPS is a percentage.