On Monday, Roche Diagnostics Korea announced the launch of uPath PD-L1 (SP263) Image Analysis Algorithm, an automated AI tool designed to rapidly detect PD-L1 biomarkers in non-small cell lung cancer (NSCLC) patients.

The product operates on uPath enterprise software and serves as a companion diagnostic that helps identify NSCLC patients who are candidates for licensed therapies. Specifically, it supports pathologists in detecting and semi-quantifying PD-L1 protein in slide images of formalin-fixed, paraffin-embedded NSCLC tissue stained with the Ventana PD-L1 (SP263) assay.

Lung cancer is one of the most common cancers in the world, claiming 1.59 million people annually, and NSCLC, in particular, accounts for approximately 85 percent of lung cancer cases, according to the International Agency for Research on Cancer (IARC). 

However, researchers estimate that 20-25 percent of patients with stage 3 or 4 NSCLC who are refractory to conventional therapies can respond to immunotherapies and recover to live normal lives with long-term survival.

Accordingly, the uPath PD-L1 (SP263) imaging algorithm provides pathologists with a quantitative calculation of the PD-L1 biomarker, enabling them to make more objective and rapid readings to help guide patient treatment decisions, said a company official.

"We are very pleased that the uPath PD-L1 (SP263) Image Algorithm has been approved in Korea, paving the way for faster and more accurate diagnosis for NSCLC patients treated with immunotherapies," remarked Roche Diagnostics Korea CEO Kit Tang. "As a pioneer in companion diagnostics, we will continue to create an enabling environment for innovative diagnostic solutions for cancer patients in Korea."