Guardant Health Japan, a partner of Eli Lilly, secured approval from Japanese regulators for the Guardant360 CDx genomic profiling panel.
The panel functions as a companion diagnostic for Lilly’s breast cancer drug, Inluriyo (imlunestrant). The approved test identifies patients carrying ESR1 mutations, making them eligible for Inluriyo treatment.
This regulatory milestone supports the commercialization and targeted use of Inluriyo in the Japanese market. The approval ensures the therapy is directed toward the patient population most likely to benefit.