Roche's VENTANA PD-L1 Assay gains CE label expansion to inform treatment

Roche announced the launch of the VENTANA PD-L1 (SP263) Assay as an in vitro diagnostic2 test for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, to identify untreated and previously treated metastatic non-small cell lung cancer patients eligible for the immunotherapy. KEYTRUDA is marketed by Merck & Co., Inc., Kenilworth N.J., US, known as MSD outside the US and Canada.

Lung cancer remains the leading cause of cancer deaths, with an annual estimated 12.9 percent of all new cancer cases and nearly 1.6 million deaths worldwide. NSCLC accounts for approximately 85 percent of all lung cancer cases.4 During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.5

The VENTANA PD-L1 (SP263) Assay is the only fully automated PD-L1 assay for KEYTRUDA to launch on Roche's BenchMark series of instruments. The launch should significantly increase patient access to PD-L1 testing given Roche's extensive global diagnostic instrument base.

"Roche first launched the VENTANA PD-L1 (SP263) Assay in September 2016 as a diagnostic test for previously treated metastatic NSCLC patients in countries accepting the CE mark. We are very pleased to expand its application to include patients being considered for KEYTRUDA immunotherapy as the first line of treatment," said Ann Costello, Head of Roche Tissue Diagnostics. "The assay provides new insights into possible treatment options for this potentially deadly disease."

Roche will continue to pursue regulatory approval for the VENTANA PD-L1 (SP263) Assay in other cancer indications and in other geographies. For more information, go to PDL1ihc.com.