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Necitumumab ELISA Kit

Catalog #:   KDB86903 Specific References (49) DATASHEET
Applications: Used for the quantitative determination of Necitumumab concentration in serum and plasma.
Sample type: Plasma, Serum
Sensitivity: 6.05 ng/mL
Range: 9.38 - 600 ng/mL
Overview

Catalog No.

KDB86903

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human EGFR has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Necitumumab in the sample competitively binds to the pre-coated protein with biotin-labeled Necitumumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Necitumumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

Used for the quantitative determination of Necitumumab concentration in serum and plasma.

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

9.38 - 600 ng/mL

Sensitivity

6.05 ng/mL

Precision

Intra-Assay Precision (Precision within an assay): <20%

Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.

Inter-Assay Precision (Precision between assays): <20%

Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

 

Intra-Assay Precision

Inter-Assay Precision

Sample

1

2

3

1

2

3

n

16

16

16

24

24

24

Mean (ng/mL)

392.4

71.0

24.2

231.4

65.8

23.4

Standard deviation

61.0

9.5

3.6

44.5

11.9

4.5

CV (%)

15.5

13.4

15.1

19.2

18.1

19.2

 

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.

Alternative Names

11F8, IMC-11F8, LY3012211, CAS: 906805-06-9

Background

Necitumumab (IMC-11F8, LY3012211) is a second-generation fully human immunoglobulin (Ig) G1 kappa isotype monoclonal antibody (mAb) that acts as an antagonist to direct against the extracellular region of epidermal growth factor receptor (EGFR). It was developed by Eli Lilly & Co (Indianapolis, IN, USA) and produced in genetically engineered mammalian NS0 cells. It was first approved by the U.S. Food and Drug Administration (FDA) under the brand name Portrazza in 2015, for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). After that, it has gained the approval for marketing in the Europe Union and Japan respectively in 2016 and 2017. It is not indicated for treatment of non-squamous NSCLC. Currently, there are several ongoing clinical trials investigating necitumumab in the treatment of NSCLC in several di铿€erent settings. It is currently being studied in combination with pre-existing agents, such as osimertinib, pembrolizumab, nabpaclitaxel, and carboplatin, as well as with new agents under investigation, abemaciclib and AZD9291. Necitumumab is currently being evaluated in the second-line setting following treatment failure or progression with front-line EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.

Data Image
  • Experiment Example
    CALCULATION OF RESULTS
    Average the duplicate readings for each standard and sample. Construct a standard curve by plotting the mean absorbance for each standard on the Y-axis against the concentration on the X-axis and draw a best fit curve through the points on the graph. Do not include the blank in the standard curve. The data may be linearized by plotting the log of the Necitumumab concentrations versus the log of the O.D. and the best fit line can be determined by regression analysis. This procedure will produce an adequate but less precise fit of the data. If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
References

ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor-Mutated Advanced Non-Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib., PMID:40466026

Skin disorder within 30 days is a favorable prognostic factor in patients with lung squamous cell carcinoma treated with necitumumab plus gemcitabine and cisplatin: a sub-analysis of the NINJA study., PMID:40093977

A Case of EGFR-mutant Squamous Cell Lung Cancer Treated With Necitumumab Combination Therapy., PMID:40010994

Clinical impact of hypomagnesemia induced by necitumumab plus cisplatin and gemcitabine treatment in patients with advanced lung squamous cell carcinoma: a subanalysis of the NINJA study., PMID:39957806

Afatinib and Necitumumab in EGFR-Mutant NSCLC with Acquired Resistance to Tyrosine Kinase Inhibitors., PMID:39866193

A Case of Advanced Biliary Tract Cancer With EGFR Amplification That Responded to Necitumumab., PMID:39540676

Transforming Lung Cancer Management: A Promising Case Study of Immune Checkpoint Inhibitor Success Following a Multidisciplinary Approach., PMID:39410563

Effects of N361 Glycosylation on Epidermal Growth Factor Receptor Biological Function., PMID:39071333

Enhancing Neutrophil Cytotoxicity of a Panel of Clinical EGFR Antibodies by Fc Engineering to IgA3.0., PMID:38958494

Association between skin toxicity and efficacy of necitumumab in squamous non-small-cell lung cancer: a pooled analysis of two randomized clinical trials-SQUIRE and JFCM., PMID:38520847

[Enhancement of Antitumor Effect by the Combined Use of Anti-EGFR Antibody(Necitumumab)and PD-1 Inhibitor]., PMID:38247069

Multicenter, Retrospective Study to Evaluate Necitumumab Plus Cisplatin and Gemcitabine After Immune Checkpoint Inhibitors in Advanced Squamous Cell Lung Cancer in Japan: The NINJA Study., PMID:38046378

A Phase I/II Study of Necitumumab Plus Pembrolizumab, Nab-Paclitaxel, and Carboplatin for Previously Untreated Advanced Squamous Non-Small Cell Lung Cancer Study: (NEJ048A/NEXUS)., PMID:36849264

Necitumumab plus gemcitabine and cisplatin in previously treated lung squamous cell carcinoma., PMID:36331673

Acquired perforating dermatosis induced by necitumumab., PMID:35686644

Treatment Sequencing Strategies in Lung Cancer., PMID:35599008

Application of Approved Cisplatin Derivatives in Combination Therapy against Different Cancer Diseases., PMID:35458666

Objective Quantitation of EGFR Protein Levels using Quantitative Dot Blot Method for the Prognosis of Gastric Cancer Patients., PMID:35079437

Accurate determination of epitope for antibodies with unknown 3D structures., PMID:34432559

Lung squamous cell carcinoma with severe hypomagnesemia due to cisplatin plus gemcitabine in combination with necitumumab therapy: A case report., PMID:34061460

EGFR targeting for cancer therapy: Pharmacology and immunoconjugates with drugs and nanoparticles., PMID:33188892

Necitumumab plus platinum-based chemotherapy versus chemotherapy alone as first-line treatment for stage IV non-small cell lung cancer: a meta-analysis based on randomized controlled trials., PMID:32954751

The Latest Battles Between EGFR Monoclonal Antibodies and Resistant Tumor Cells., PMID:32793499

Efficacy and safety of necitumumab and pembrolizumab combination therapy in patients with Stage IV non-small cell lung cancer., PMID:32114283

Effects of adding necitumumab to first-line chemotherapy in patients with stage IV non-small-cell lung cancer: Meta-analysis., PMID:31822198

A phase 1b study of necitumumab in combination with abemaciclib in patients with stage IV non-small cell lung cancer., PMID:31586771

A phase II study of nab-paclitaxel and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer., PMID:31445354

The effects of somatic mutations on EGFR interaction with anti-EGFR monoclonal antibodies: Implication for acquired resistance., PMID:31228284

Corrigendum to "Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line treatment for stage IV squamous non-small cell lung cancer: A phase 1b and randomized, open-label, multicenter, phase 2 trial in Japan" [Lung Cancer, 129 (March) (2019) 55-62]., PMID:31014853

Most clinical anti-EGFR antibodies do not neutralize both wtEGFR and EGFRvIII activation in glioma., PMID:31002307

Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line treatment for stage IV squamous non-small cell lung cancer: A phase 1b and randomized, open-label, multicenter, phase 2 trial in Japan., PMID:30797492

First-line treatment of patients with advanced or metastatic squamous non-small cell lung cancer: systematic review and network meta-analysis., PMID:30746213

The people behind the papers - Elena Popa and Abigail Tucker., PMID:30737241

Necitumumab for the treatment of advanced non-small-cell lung cancer., PMID:30501503

Immune Effector Functions of Human IgG2 Antibodies against EGFR., PMID:30282813

Necitumumab in the treatment of non-small-cell lung cancer: clinical controversies., PMID:30075697

Necitumumab: a new option for first-line treatment of squamous cell lung cancer., PMID:30025476

Algorithm for the treatment of advanced or metastatic squamous non-small-cell lung cancer: an evidence-based overview., PMID:29910650

Predictive biomarkers for response to EGFR-directed monoclonal antibodies for advanced squamous cell lung cancer., PMID:29905778

Breakthroughs in the treatment of advanced squamous-cell NSCLC: not the neglected sibling anymore?, PMID:29862232

The Budget Impact of Including Necitumumab on the Formulary for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer: U.S. Commercial Payer and Medicare Perspectives., PMID:29799326

Venous thromboembolism with EGFR monoclonal antibody necitumumab in stage IV non-small cell lung cancer: A retrospective cohort analysis., PMID:29787943

A retrospective examination of the US Food and Drug Administration's clinical pharmacology reviews of oncology biologics for potential use of therapeutic drug monitoring., PMID:29343970

Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer., PMID:29175116

Molecular Basis for Necitumumab Inhibition of EGFR Variants Associated with Acquired Cetuximab Resistance., PMID:29158469

EGFR Gene Copy Number by FISH May Predict Outcome of Necitumumab in Squamous Lung Carcinomas: Analysis from the SQUIRE Study., PMID:29158193

Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer., PMID:29158123

EGFR immunohistochemistry as biomarker for antibody-based therapy of squamous NSCLC - Experience from the first ring trial of the German Quality Assurance Initiative for Pathology (QuIP®)., PMID:29108919

Meta-analysis of first-line therapies with maintenance regimens for advanced non-small-cell lung cancer (NSCLC) in molecularly and clinically selected populations., PMID:28675660

Datasheet

Document Download

Necitumumab ELISA Kit.pdf

 

$ 1128
Product specifications
96 T 1128

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