Lung cancer remains the leading cause of cancer mortality worldwide, comprising almost 20% of all cancer deaths. Lung cancer death rates are often highest in regions such as North America, Europe and East Asia. Across Europe in 2020, there were around 257,293 lung cancer-related-deaths. Most patients were diagnosed with advanced disease, resulting in poor survival rates. Non-small cell lung cancer (NSCLC) accounts for ∼84% of all lung cancer cases, imposing a substantial social and financial burden. However, a new immunotherapy — based on inhibition of programmed death-1 (PD-1) receptors and programmed death-ligand 1 (PD-L1) — shows a promising method for certain lung cancer patients and offers a new hope for patients and clinicians. PD-L1 expression on tumor cells is a marker of PD-1/PD-L1 antibody treatment efficacy for advanced NSCLC. The ESMO Clinical Practice Guideline indicates that PD-L1 expression testing by IHC is also mandatory before initiating PD-1/PD-L1 antibody treatment.

Both PD-1 and PD-L1 inhibitors target the interaction between PD-1 and PD-L1. The PD-1 receptor is expressed on the immune system’s T cells and B cells, while its ligand PD-L1 is expressed on a variety of cells in the body, including many tumour cells. The interaction between PD-L1 and PD-1 results in dampening an immune response. Tumour cells can evade the body’s immune system by turning it off just as it begins to mount a response against them. However, scientists have discovered how to block this “immune checkpoint” and let the body continue its attack. When PD-1 on the T cell binds to PD-L1 on the tumour cell, the T cell becomes deactivated, allowing the cancer cell to evade immune attack (Fig. 1). Inhibitors of PD-1 and PD-L1 can prevent the tumour cell from binding to PD-1, enabling the T cell to remain active and co-ordinate an attack (Fig. 2).

Fig.1 Deactivated T cell

Fig.2 Activated T cell

MEDx Translational Medicine has established production workshops that meet the quality management requirements of ISO 13485, with a standard production process and strict quality control. Our PD-L1 (E1L3N) antibody kit (IHC) are used for in vitro qualitative testing of the protein expression of Programmed Death-Ligand 1 (PD-L1) in 4% neutral (phosphate buffered) formalin-fixed, paraffin-embedded (FFPE) NSCLC to assist with identifying lung cancer patients who can be treated with PD-1 inhibitor drug OPDIVO^®(Bristol-Myers Squibb,Nivolumab). The PD-L1 IHC Kit (CE IVD) is a standardized IHC assay with all necessary components for 15, 30 or 50 tests in one kit.

Competitive Advantages:

² Higher Performance: Consistency as high as 97.77% compared with FDA approval for PD-L1 CDx. AI-based pathology

² Companion Diagnostics: Identifying NSCLC patients for treatment with OPDIVO^® (nivolumab).

² Widespread Applications：Extending more indications such as NSCLC, GC, EC, and TNBC etc.

² Multi-platform Compatibility：Suitable for Leica Bond Max, Leica Bond III, Ventana,etc.