On September 30, 2025, the U.S. Food and Drug Administration approved Guardant Health’s Guardant360® CDx as a companion diagnostic for Eli Lilly’s new advanced breast cancer treatment, Inluriyo™ (imlunestrant). The approval was announced today by Guardant Health and confirms that Guardant360® CDx can identify patients with ESR1 mutations who may benefit from Inluriyo, a therapy for estrogen‑receptor‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer that progressed after at least one line of endocrine therapy.
Guardant360® CDx is the first FDA‑approved blood test for complete genomic testing and is now the sixth CDx claim approved by the FDA for Guardant’s platform. It is also the second FDA‑approved indication in breast‑cancer treatment, following the 2023 approval for ORSERDU™ (elacestrant). The test is broadly covered by Medicare and commercial insurers, representing coverage for more than 300 million lives, and it detects a range of ESR1 mutations—including E380, V422del, S463, L469, L536, Y537, and D538—identified in the Phase 3 EMBER‑3 trial.
The approval expands Guardant’s revenue base by adding a new companion‑diagnostic partnership with Eli Lilly, creating a direct sales channel for Guardant360® CDx in the breast‑cancer market. It also strengthens Guardant’s position as a leader in liquid‑biopsy diagnostics, providing clinicians with a minimally invasive tool that can guide targeted therapy decisions for a significant subset of advanced‑breast‑cancer patients. The partnership is expected to generate incremental revenue and enhance Guardant’s competitive moat in the precision‑oncology space.
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