Anti-PD-L1 (SP142) Rabbit Monoclonal Antibody Reagent

Product Name	Anti-PD-L1 (SP142) rabbit monoclonal antibody reagent (immunohistochemical method)
Classification	Class III
Approval Date	6/24/2021
Review Division	Center for Medical Device Evaluation of NMPA
Applicant Name	Roche Diagnostics GmbH
Registration Pathway	Imported Companion Diagnostic Reagent Priority Review Pathway
Product Description	Recombinant rabbit monoclonal antibody (clone number: SP142), the antibody is diluted with a Tris buffer solution containing carrier protein, sodium azide, EDTA and Brij-35. The specific content is as follows: This product is a recombinant rabbit monoclonal antibody produced from the supernatant of the purified cell culture medium. A 5mL VENTANA PD-L1 (SP142) Assay dispenser contains approximately 36 μg of rabbit monoclonal antibody. The antibody is diluted with a 0.05 M Tris buffer solution containing 0.3% carrier protein and 0.05% sodium azide (a preservative), 0.01 M EDTA, and 0.05% Brij-35. The total protein concentration of this reagent is approximately 3 mg/mL. The specific antibody concentration is about 7 μg/mL.
Indications for Use	This product is used to qualitatively detect the expression level of programmed death ligand-1 (PD-L1) protein in formalin-fixed and paraffin-embedded tissue sections. Used to assist in the identification of patients treated with TECENTRIQ® (atelizumab) for non-small cell lung cancer (NSCLC), the threshold is ≥50% of any staining intensity TC (percentage of PD-L1 expressing tumor cells) or any staining intensity ≥10% IC (the proportion of PD-L1 expressing tumor infiltrating immune cells in the area of the tumor).
Summary of Non-Clinical Testing	The applicant submitted the following non-clinical research materials: Major Raw MaterialsResearch on production technology and reaction systemAnalysis performance evaluationSpecificity evaluationPositive value and reference intervalsStability study Contact us to learn more about how to prepare the non-clinical study of this type of product
Summary of Clinical Evaluation	This product is a companion diagnostic reagent, which is jointly developed by Roche Diagnostics and Roche Pharmaceuticals. The clinical trials submitted in this application are jointly developed clinical trials including IMpower110 international multi-center clinical trials. The applicant also provided a study on the consistency of the readings of domestic pathologists completed in China. This is a phase III, multicenter, international, randomized, open-label trial involving 572 patients with stage IV NSCLC who have not previously received chemotherapy for metastatic disease, including patients with EGFR mutations or ALK rearrangements. The purpose of this study is to evaluate the safety of TECENTRIQ compared to platinum-based drugs (cisplatin or carboplatin, at the discretion of the investigator) combined with pemetrexed (non-squamous disease) or gemcitabine (squamous disease) combined with chemotherapy Sex and efficacy. Use VENTANA PD-L1 (SP142) Assay to stain patient specimens and evaluate the acceptability of staining and PD-L1 expression. Patient specimens were FFPE NSCLC tissues from biopsy (66.0%), resection (15.7%) or other types (18.3%); 72.4% were from primary tumors, and 27.6% were from metastatic tumors. Contact us to learn more about the clinical evaluation of this type of product
Product Risk/Benefit Analysis	Refer to the “ISO14971:2012 Medical Device Risk Management Application to Medical Devices” standard to conduct risk analysis on this product. Although it is currently believed that the benefits of the product outweigh the risks, in order to ensure the safety of the use of machinery, based on the prevention and control of the main residual risks, the limitations of the product inspection method and the precautions in use have been introduced in the product manual. Contact us to learn more about the risk/benefit analysis of this type of product