Guardant Health Gains After FDA Nod for Breast Cancer Test
The approval links Guardant's Guardant360 CDx blood test to Eli Lilly's new Inluriyo treatment for ESR1-mutated breast cancer, boosting its stock.
Shares of Guardant Health (NASDAQ: GH) climbed Tuesday after the company secured a key regulatory win for its flagship liquid biopsy. The U.S. Food and Drug Administration (FDA) approved the Guardant360® CDx blood test as a companion diagnostic for Inluriyo™ (imlunestrant), a new advanced breast cancer therapy from Eli Lilly and Company.
The news sent Guardant Health's stock higher in morning trading before for the day. The approval marks a significant step for the precision oncology company, solidifying the role of its blood test in guiding targeted cancer treatments.
This latest regulatory milestone is the sixth FDA companion diagnostic approval for Guardant360 CDx. Specifically, the allows clinicians to identify patients with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer who may benefit from Eli Lilly's Inluriyo. This allows patients to be matched with a promising therapy through a simple blood draw, avoiding the need for a more invasive tissue biopsy.
"The approval of Guardant360 CDx as a companion diagnostic for Inluriyo is a significant step forward in personalized medicine for advanced breast cancer," said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. "This demonstrates the clinical utility of our liquid biopsy technology in helping to identify patients who may benefit from targeted therapies."
The decision expands the market for Guardant's diagnostic tools and reinforces its position in the competitive landscape of genomic testing. It follows other positive developments, including a partnership with Quest Diagnostics to broaden access to Guardant's Shield™ test for colorectal cancer screening. remains positive, with this approval likely to strengthen confidence in the company's growth trajectory and its expanding portfolio of cancer diagnostics.