Biotech Values

[DewDiligence]

FDA approves GH’s liquid-biopsy test to guide treatment for solid tumors generally, and to serve as a companion diagnostic for Tagrisso:

https://www.globenewswire.com/news-release/2020/08/07/2075187/0/en/Guardant-Health-Guardant360-CDx-First-FDA-Approved-Liquid-Biopsy-for-Comprehensive-Tumor-Mutation-Profiling-Across-All-Solid-Cancers.html

Guardant Health, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor).

The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.