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KRIBIOLISA™ Amivantamab ELISA

Enzyme Immunoassay for the Quantitative Determination of Amivantamab in serum and plasma

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Introduction:

Amivantamab is a fully human Fc-active immunoglobulin G1 (IgG1) bi-specific antibody with high affinity, developed for the treatment of non-small cell lung cancer. Amivantamab targets the extracellular domains of EGFR and MET, leading to inhibition of both pathways independent of their intracellular cancer-driving or treatment-acquired mutation(s). The potential broad applicability of amivantamab can be attributed to its novel design leading to dual targeting of EGFR and MET, activation of innate immune cells through enhanced FcR binding, and improved safety profile. It has been approved by the US FDA in 2021 and is also being investigated in combination with lazertinib versus osimertinib; and in combination with carboplatin-pemetrexed chemotherapy compared to carboplatin-pemetrexed.

Intended Use:

The KRIBIOLISA™TM Amivantamab ELISA is used as an analytical tool for quantitative determination of Amivantamab in human serum and plasma.

Principle:

EGFR Protein is pre-coated onto microwells. Samples and standards are pipetted into microwells. Amivantamab present in the sample are bound by the capture antibody. Then, a MET protein conjugated to HRP is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Amivantamab in the sample. Color development is then stopped by addition of stop solution.Absorbance is measured at 450 nm.

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