Guardant Health Gets FDA Approval for Guardant360 CDx as Companion Diagnostic for Orserdu

By Chris Wack

Guardant Health Inc. said Monday that the U.S. Food and Drug Administration has approved its Guardant360 CDx liquid biopsy test, to be commercialized by Stemline Therapeutics Inc., a wholly-owned subsidiary of Menarini Group.

The company said the Guardant360 CDx test was approved to be a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with Orserdu elacestrant, a nonsteroidal selective estrogen receptor degrader.

The FDA approved Guardant360 CDx as a companion diagnostic for postmenopausal women or adult men with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

The approval as a companion diagnostic for Orserdu is Guardant Health's fifth FDA approval for the Guardant360 CDx test and its first in breast cancer.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

01-30-23 0744ET