FDA approved Roche Diagnostic Kit for lung cancer diagnosis

June 11, 2023

Recently, Roche announced that the US FDA has approved its diagnostic kit VENTANA PD-L1 (SP142) as a complementary diagnosis to identify PD-L1 expression levels in patients with treated metastatic non-small cell lung cancer (NSCLC). Tumor immunotherapy TECENTRIQ (atezolizumab) was used.

FDA approved Roche Diagnostic Kit for lung cancer diagnosis

On May 18, 2016, the first PD-L1 monoclonal antibody, atezolizumab, was approved by the US FDA for the treatment of urothelial carcinoma (UC). The FDA also approved the above-mentioned auxiliary diagnostic VENTANA PD-L1 (SP142) assay reagent from TECENTRIQ. The cassette, which is used to determine the level of PD-L1 expression in tumor-infiltrating immune cells, is intended to help clinicians judge patients who can benefit more from treatment with atezolizumab.

FDA approved Roche Diagnostic Kit for lung cancer diagnosis

PD-1/PD-L1 immunological checkpoint treatment (Source: Roche)

Lung cancer is one of the leading causes of cancer deaths, accounting for an estimated 12.9% of all new cancer cases each year, and about 1.59 million people worldwide die. At the same time, the death toll from lung cancer accounts for about one-fifth of all cancer-related deaths. NSCLC is one of two major types of lung cancer, accounting for approximately 85% of all lung cancer cases. Over the past three decades, lung cancer has had the least improvement in survival compared to other cancers. In recent years, treatment programs targeting the PD-1/PD-L1 immunological checkpoint have made encouraging progress in the treatment of a series of refractory cancers such as lung cancer.

FDA approved Roche Diagnostic Kit for lung cancer diagnosis

Multiple cell types in the tumor microenvironment (Source: Roche)

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