Enzyme-linked immunosorbent assay for the qualitative determination (screening) of antibodies to nivolumab (Opdivo®) in serum and plasma. The Assay Genie® Antibody to nivolumab (Opdivo®) Enzyme-Linked-Immunosorbent Assay (ELISA) Kit is intended for the qualitative determination of antibodies to nivolumab (Opdivo®) in serum and plasma. It is for professional use only.

The Assay Genie Antibody to Nivolumab (Opdivo®) ELISA is a sandwich assay for the determination of anti-nivolumab antibodies in serum and plasma samples. During the first incubation period, antibodies to Nivolumab (ATN) in patient serum/ plasma samples are captured by the drug Nivolumab (Opdivo®) coated on the wall of the microtiter wells. After washing away the unbound components from samples, a peroxidase-labelled specific conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen-substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of anti-nivolumab antibodies in sample

Nivolumab is a fully human IgG4 monoclonal antibody that acts as an immunomodulator by blocking ligand activation of programmed cell death 1 (PD-1) receptor on T cells. Nivolumab binds to the programmed cell death 1 (PD-1) receptor and selectively blocks interaction with its programmed death ligands PD-L1 and PD-L2. Upregulation of PD-1 ligands occurs in some tumors and signalling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumour tissue. The inhibitory effect of PD-1 and its ligands occurs through the promotion of apoptosis in antigen specific T cells while simultaneously blocking apoptosis in suppressor T cells. Blocking PD-1 activity has been shown to lead to decreased tumour growth in mouse tumour models.

Nivolumab (Opdivo®) is indicated for use in patients with unresectable (cannot be surgically removed) or metastatic melanoma who no longer respond to other drugs. It is also used to treat metastatic squamous non-small cell lung cancer and is a second-line treatment for renal cell carcinoma after anti-angiogenic treatment has failed.

Nivolumab is administered as an intravenous infusion over 60 minutes every 2 weeks. Nivolumab is indicated for the treatment of unresectable or metastatic melanoma for patients who no longer respond to treatment with other drugs. It is intended for use in patients who have been previously treated with ipilimumab and is used for melanoma patients after treatment with ipilimumab and a BRAF inhibitor in patients whose tumors express BRAF V600 gene mutations. Historically there have been very few effective treatments for advanced melanoma, which is why this product was approved under an FDA accelerated program to allow earlier patient access.

As with any biologic therapeutic, immunogenicity, in the form of anti-nivolumab antibodies can occur. The demonstration of anti-nivolumab antibodies during treatment with nivolumab is a major concern. The Assay Genie Anti-Nivolumab ADA Qualitative ELISA Kit can be efficiently used for monitoring anti-nivolumab antibodies during therapy and offers the clinician a tool for decision on possible preventive measures such as the potential addition of an immunosuppressive drug to reduce anti-nivolumab antibodies.

Opdivo is a registered trademark of Bristol-Myers Squibb Company.