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EGFR pharmDx Kit is a qualitative immunohistochemical kit system that includes all reagents necessary to identify expression of epidermal growth factor receptor (EGFR) protein on the surface of normal and neoplastic cells. EGFR protein is also...
EGFR pharmDx Kit is a qualitative immunohistochemical kit system that includes all reagents necessary to identify expression of epidermal growth factor receptor (EGFR) protein on the surface of normal and neoplastic cells. EGFR protein is also called HER1 protein. Through the use of standard methods and reagents, EGFR pharmDx Kit will provide reproducible results from laboratory to laboratory. EGFR is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Erbitux® (cetuximab) or Vectibix™ (panitumumab).|The kit utilizes a simple two-step staining procedure and is suitable for formalin-fixed, paraffin-embedded specimens. Results can be available within 1 day, giving clinicians EGFR expression levels in a quick and reliable manner. The kit has been designed for manual use.
PD-L1 IHC 28-8 pharmDx is a qualitative IHC assay intended for use in the detection of PD-L1 protein in FFPE tissues using EnVision FLEX visualization system on Autostainer Link 48.
Code SK005|PD-L1 IHC 28-8 pharmDx 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) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.|Tumor indications*|NSCLC: PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). As a Companion Diagnostic for ≥ 1% tumor cell expression.|Non-squamous NSCLC: PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).|SCCHN: PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab).|UC: PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO® (nivolumab).|See the OPDIVO® and YERYOV® product labels for specific clinical circumstances guiding PD-L1 testing.|PD-L1 IHC 28-8 pharmDx Kit
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal rabbit antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent, 100 slides in total).|PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® is a trademark owned by Bristol-Myers Squibb.|Read more about <a href=/en/product/pharmdx/pd-l1-ihc-28-8-overview >PD-L1 IHC 28-8 pharmDx </a >.|Interpretation training is now available for PD-L1 IHC 28-8 pharmDx. To learn more, visit PD-L1 IHC 28-8 pharmDx eLearning.
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal rabbit antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent, 100 slides in total).|PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® is a trademark owned by Bristol-Myers Squibb.|Read more about <a href=/en/product/pharmdx/pd-l1-ihc-28-8-overview >PD-L1 IHC 28-8 pharmDx </a >.|Interpretation training is now available for PD-L1 IHC 28-8 pharmDx. To learn more, visit PD-L1 IHC 28-8 pharmDx eLearning.
EGFR pharmDx Kit is a qualitative immunohistochemical kit system that includes all reagents necessary to identify expression of epidermal growth factor receptor (EGFR) protein on the surface of normal and neoplastic cells. EGFR protein is also...
EGFR pharmDx Kit is a qualitative immunohistochemical kit system that includes all reagents necessary to identify expression of epidermal growth factor receptor (EGFR) protein on the surface of normal and neoplastic cells. EGFR protein is also called HER1 protein. Through the use of standard methods and reagents, EGFR pharmDx Kit will provide reproducible results from laboratory to laboratory. EGFR is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Erbitux® (cetuximab) or Vectibix™ (panitumumab).|The kit utilizes a simple two-step staining procedure and is suitable for formalin-fixed, paraffin-embedded specimens. Results can be available within 1 day, giving clinicians EGFR expression levels in a quick and reliable manner. The kit has been designed for use on the Dako Autostainer.
PD-L1 Control Slides are intended for use as optional quality control material when stained with PD-L1 IHC 22C3 pharmDx, Code GE006.
Code T1391|PD-L1 Control Slides are intended for use as optional quality control material (including 5 slides). Each slide contains sections of two pelleted, formalin-fixed paraffin-embedded cell lines: NCI-H226 with moderate PD-L1 protein expression and MCF-7 with negative PD-L1 protein expression. They have been validated as optional control material when stained with PD-L1 IHC 22C3 pharmDx, Code GE006.
ER/PR pharmDx Kits are semi-quantitative immunohistochemical kit systems to identify estrogen receptor (ER) α protein and progesterone receptor (PR) protein expression in normal and neoplastic tissues. The assay specifically detects the ER...
ER/PR pharmDx Kits are semi-quantitative immunohistochemical kit systems to identify estrogen receptor (ER) α protein and progesterone receptor (PR) protein expression in normal and neoplastic tissues. The assay specifically detects the ER α protein as well as the PR protein located in the cell nuclei of ER and PR-expressing cells, respectively. ER/PR pharmDx Kit is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies as well as an aid in the prognosis and management of breast cancer.|The kits utilize a simple two-step staining procedure and are suitable for formalin-fixed, paraffin-embedded specimens. The kits provide all the reagents needed to run the ER/PR tests, including control slides to validate each run, and detailed instructions. A scoring guideline is included to facilitate interpretation.
HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer...
HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest specifically demonstrates overexpression of HER2 protein. Positive or negative results aid in the classification of abnormal cells/tissues and provide a basis for Herceptin® treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient's clinical history. HercepTest is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLA™ (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).|The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of HER2 protein, and detailed instructions. SK001 has been tailored especially for use on Dako Automated Link instruments.|HercepTest™, Herceptin®, PERJETA™, and KADCYLA™ are trademarks owned by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd.; HercepTest is subject to an exclusive trademark license to Agilent Technologies, Inc.
ER/PR pharmDx Kits are semi-quantitative immunohistochemical kit systems to identify estrogen receptor (ER) α protein and progesterone receptor (PR) protein expression in normal and neoplastic tissues. The assay specifically detects the ER...
ER/PR pharmDx Kits are semi-quantitative immunohistochemical kit systems to identify estrogen receptor (ER) α protein and progesterone receptor (PR) protein expression in normal and neoplastic tissues. The assay specifically detects the ER α protein as well as the PR protein located in the cell nuclei of ER and PR-expressing cells, respectively. ER/PR pharmDx Kit is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies as well as an aid in the prognosis and management of breast cancer.|The kits utilize a simple two-step staining procedure and are suitable for formalin-fixed, paraffin-embedded specimens. The kits provide all the reagents needed to run the ER/PR tests, including control slides to validate each run, and detailed instructions. A scoring guideline is included to facilitate interpretation.
HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay based on Dako's new fast IQISH hybridization buffer chemistry. The IQISH hybridization buffer is non-toxic and allows genomic DNA probe hybridization to be...
HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay based on Dako's new fast IQISH hybridization buffer chemistry. The IQISH hybridization buffer is non-toxic and allows genomic DNA probe hybridization to be performed in just 60-120 minutes. The short hybridization time results in a turnaround time of less than 4 hours for a complete FISH staining from deparaffinization to mounting.|HER2 IQFISH pharmDx is designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Gene amplification is determined from the ratio between the number of signals from the hybridization of the HER2 gene probe (red signals) and the number of signals from the hybridization of the CEN-17 reference chromosome 17 probe (green signals).|HER2 IQFISH pharmDx is indicated as an aid in the assessment of breast and gastric patients for whom Herceptin® treatment is being considered and for breast cancer patients for whom PERJETA™ or KADCYLA™ treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts). For breast cancer patient, results from the HER2 IQFISH pharmDx are intended for use as an adjunct to the information currently used for estimating prognosis in stage II, node-positive breast cancer patients.|HER2 IQFISH pharmDx is a complete system providing all reagents required to perform 20 assays. A standard validated procedure and validated interpretation guidelines are also provided.|HercepTest, Herceptin®, PERJETA™ and KADCYLA™ are trademarks owned by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd.; HercepTest is subject to an exclusive trademark license to Dako Denmark A/S.
PD-L1 IHC 22C3 pharmDx is a qualitative IHC assay intended for use in the detection of PD-L1 protein in FFPE tissues using EnVision FLEX visualization system on Autostainer Link 48.
Code SK006|PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), and triple-negative breast cancer (TNBC) tissues using EnVision FLEX visualization system on Autostainer Link 48.|PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity.|PD-L1 protein expression in gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma, HNSCC, and TNBC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.|PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC, gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma, HNSCC, and TNBC patients for treatment with KEYTRUDA® (pembrolizumab). PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with LIBTAYO® (cemiplimab-rwlc). Please refer to the full intended use
for indications and PD-L1 expression levels.|For details on staining interpretation, refer to section 13 of the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.|PD-L1 IHC 22C3 pharmDx
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing positive and negative PD-L1 protein expression, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).|Read more about PD-L1 IHC 22C3 pharmDx.|For countries outside of the United States, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.|KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.|LIBTAYO is a registered trademark of Regeneron Pharmaceuticals, Inc.
for indications and PD-L1 expression levels.|For details on staining interpretation, refer to section 13 of the Instructions for Use and indication-specific PD-L1 IHC 22C3 pharmDx Interpretation Manuals.|PD-L1 IHC 22C3 pharmDx
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing positive and negative PD-L1 protein expression, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).|Read more about PD-L1 IHC 22C3 pharmDx.|For countries outside of the United States, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.|KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.|LIBTAYO is a registered trademark of Regeneron Pharmaceuticals, Inc.
PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay intended for use in the detection of PD-L1 protein in FFPE NSCLC tissue using EnVision FLEX visualization system on Dako Omnis.
Code GE006|PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue, using EnVision FLEX visualization system for use on Dako Omnis.|PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1%.|PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.|PD-L1 IHC 22C3 pharmDx on Dako Omnis
The assay is a modular IHC assay for 60 tests. The assay has been tailored especially with EnVision FLEX visualization system on the Dako Omnis instrument. The complete assay consists of the following components (to be ordered separately):|
The assay is a modular IHC assay for 60 tests. The assay has been tailored especially with EnVision FLEX visualization system on the Dako Omnis instrument. The complete assay consists of the following components (to be ordered separately):|
- PD-L1 IHC 22C3 pharmDx (GE00621-5) for Dako Omnis (Monoclonal Mouse Anti-PD-L1, Clone 22C3, RTU (Dako Omnis) with Negative Control Reagent)
- EnVision FLEX, High pH (Dako Omnis) (GV80011-2) OR EnVision FLEX Mini Kit, High pH (Dako Omnis) (GV82311-2)
- EnVision FLEX Target Retrieval Solution, Low pH (50x) (GV80511-2)
- EnVision FLEX+ Mouse Linker (Dako Omnis) (GV82111-2)
- EnVision FLEX DAB Enhancer (Dako Omnis) (GC80611-2)
- PD-L1 Control Slides (T139130-2) (optional)
HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer...
HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest specifically demonstrates overexpression of HER2 protein. HercepTest is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLA™ (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).|K5207 has been tailored especially for use on the Dako Autostainer.|HercepTest™, Herceptin®, PERJETA™, and KADCYLA™ are trademarks owned by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd.; HercepTest is subject to an exclusive trademark license to Agilent Technologies, Inc.
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Released: April 26, 2021
Detailed scoring guidelines and technical information to ensure high-quality PD-L1 staining and diagnostic assessment of NSCLC specimens.
Detailed scoring guidelines and technical information to ensure high-quality PD-L1 staining and diagnostic assessment of urothelial carcinoma specimens.
Detailed scoring guidelines and technical information to ensure high-quality PD-L1 staining and diagnostic assessment of TNBC specimens.
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Released: October 22, 2020
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Released: August 27, 2020
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Released: July 21, 2020
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Released: July 15, 2020
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Released: July 6, 2020