KRIBIOLISA™ Margetuximab ELISA

SKU: KBI1455 Category:

58,000.00

Enzyme Immunoassay for the estimation of Margetuximab in serum and plasma.

About the kit:
– Uses anti-idiotypic monoclonal antibodies which ensures higher specificity, and low cross reactivity.
– Recovery rates are between 85 – 115%
– Validated as per US FDA guidelines for Bioassays
– Precision CV<10%

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells



Description

Background:
The HER2 oncoprotein, the product of the human ERBB2/mouse neu genes, is a member of the HER family of receptor tyrosine kinases that includes the epidermal growth factor receptor (EGFR). Of the various subtypes of breast cancer, HER2-positive breast cancer is characterized by ERBB2 overexpression, a higher grade, a more aggressive phenotype, and a worse prognosis compared to HER2-negative cancer. The introduction of trastuzumab improved patient outcomes in HER2-positive breast cancer, but notably depended substantially on polymorphisms in the FcRIIIA/CD16A receptor, whereby low affinity 158F CD16A variants are associated with shorter progression-free survival and worse patient outcomes. Margetuximab (formerly MGAH22) is an Fc-engineered human/mouse chimeric anti-HER2 IgG1 monoclonal antibody derived from the same mouse 4D5 clone that trastuzumab is derived from and is produced in Chinese Hamster Ovary (CHO) culture.Margetuximab binds to the same epitope on the HER2 extracellular domain and induces the same effects as trastuzumab. However, due to its modified Fc region, margetuximab binds with higher affinity to both CD16A variants and exhibits weaker binding to the inhibitory CD32B Fc receptor, resulting in more efficient antibody-dependent cell-mediated cytotoxicity (ADCC) and increased efficacy compared to trastuzumab. Margextuximab was granted FDA approval on December 16, 2020, and is currently marketed under the trademark MARGENZA by MacroGenics, Inc.

Intended Use:
For Estimation of Margetuximab in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

If you have published a paper by using any of our ELISA since 01/01/2023, kindly fill out the “Krishgen Publication Reward Application Form” with complete information and send it by at email: info@krishgen.com, with the subject “Krishgen Publication Reward”. We will get back to you with the Amazon / Krishgen Credit Reward after we confirm it ASAP!

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Additional information

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

0 ng/ml – 2000 ng/ml

Specificity

80% – 120% to Margetuximab

Cross Reactivity

< 0.5% cross-reactivity observed with related biomarker.

Interference

No significant interference observed with available related molecules.

Regulatory Status

Research Use Only

Research Area

Biosimilars / Therapeutic Drug Monitoring

Entez Gene ID

MGAH-22 Human

Alternate Names / Synonyms

Margetuximab, margetuximab-cmkb

Storage Temperature

Store the unopened product at 2-8 Deg C. Do not use past expiration date.

Validation

The kit uses a biosimilar research grade standard / calibrator. The standard / calibrator has been validated against WHO/NIBSC standard and/or against commercially sourced innovator drug where available. Please refer the IFU for more details.

Disclaimer

Trade name indicated is for reference purposes only. It does not reflect any licences or patent usage. The tradename is the registered trademark of the respective owners only.

Long Name

Protein Based Therapies – Monoclonal Antibody