| Field | Specification |
|---|---|
| Target | |
| Alternative names | RC48-0, Disitamab Vedotin |
| UniProt # | |
| CAS no. | |
| Reactivity | |
| Applications | |
| Assay type | |
| Sample type(s) | Plasma, Serum |
| Sensitivity | |
| Detection range | |
| Detection method | |
| Storage | |
| Shipping | |
| Catalog no. (Mfr.) | |
| Main SKU |
Assay Principle
Disitamab ELISA Kit is a quantitative colorimetric ELISA designed to measure Disitamab in research samples. Concentrations are interpolated from a standard curve, giving traceable quantitative readouts for comparative analyses across experimental conditions.
Background
Disitamab vedotin (Aidixi®) is an antibody-drug conjugate comprising a monoclonal antibody against human epidermal growth factor receptor 2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl auristatin E. Disitamab vedotin is being developed by RemeGen for the treatment of solid tumours, including gastric cancer; Seagen has the right to develop disitamab vedotin globally outside of RemeGen's territory. In June 2021, disitamab vedotin received its first Biologics License Application (BLA) approval in China for the treatment of patients with HER2-overexpressing (defined as IHC2+ or 3+) locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy regimens. Disitamab vedotin as monotherapy or combination therapy is also in clinical development for the treatment of other solid tumours globally, including urothelial cancer in China and the USA, and biliary tract cancer, non-small cell lung cancer and HER2-positive and HER2-low expressing breast cancer in China. This article summarizes the milestones in the development of disitamab vedotin leading to this first approval for locally advanced or metastatic gastric cancer.
Specifications
| Assay Type | Quantitative Colorimetric ELISA |
|---|---|
| Detection Method | Colorimetric |
| Plate Format | 96-well (96T) |
| Sample Types | Plasma, Serum |
| Sensitivity | 0.156 μg/mL |
| Detection Range | 0.31-5 μg/mL |
| Recovery | 80-120% |
| Stability & Storage | The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition. |
| Shipping | 2-8 °C |
| CAS Number | 2185868-98-6 |
| UniProt | P04626 |
| Alternative Names | RC48-0, Disitamab Vedotin |
Performance Data
The kit provides a quantitative range of 0.31-5 μg/mL, an analytical sensitivity of 0.156 μg/mL, typical spike recovery of 80-120%. Plan sample dilutions so readouts fall within the linear portion of the standard curve, and evaluate matrix effects with dilution-linearity and spike-recovery controls.
Target Notes
The target is also referenced in the literature as RC48-0, Disitamab Vedotin. Curated target information is available under UniProt accession P04626. The corresponding compound is registered under CAS 2185868-98-6.
Common Research Applications
- Pharmacokinetic profiling of the drug in preclinical and translational research models
- Bioanalytical method development, bridging, and comparability studies
- Stability and formulation studies requiring reproducible concentration readouts
Safety & Handling
For Research Use Only. Not for diagnostic or therapeutic use. Handle all reagents and samples according to your institution's laboratory safety guidelines, and store components as recommended to preserve assay performance.
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