Guardant Health Blood Test Receives Japanese Approval as CDx for Eli Lilly Breast Cancer Drug

Original from: genomeweb

Guardant Health Japan said Monday that it has received approval from that country's Ministry of Health, Labour, and Welfare (MHLW) for its Guardant360 CDx as a companion diagnostic for identifying ESR1 mutations in breast cancer patients.

The Guardant360 CDx is the first blood-based companion diagnostic to be approved in Japan for the detection of ESR1 mutations.

The sequencing-based comprehensive genomic profiling test is meant to be used in patients with hormone receptor–positive, HER2-negative breast cancer with disease progression following endocrine therapy to assess whether they are candidates for treatment with Eli Lilly's Inluriyo (imlunestrant).

ESR1 mutations are known to drive resistance to aromatase inhibitors, and according to Guardant, in a recent trial such mutations were detected in 20 percent to 40 percent of patients with locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor.

Guardant received US Food and Drug Administration approval of the Guardant360 CDx as a companion diagnostic for Inluriyo in September.

Source: Guardant Health Blood Test Receives Japanese Approval as CDx for Eli Lilly Breast Cancer Drug