Guardant Health, Inc., a pioneering precision oncology company, has announced that the FDA has granted marketing authorization to Guardant360® CDx as a companion diagnostic test for identification of those patients suffering from HR-positive, HER2-negative advanced/metastatic breast cancer who carry ESR1 mutations and can be treated with ETCAMAH™ (camizestrant) developed by AstraZeneca. This is a first-ever FDA-approved liquid biopsy companion diagnostic tool for longitudinal monitoring in breast cancer that will help conduct serial blood tests every three months on patients receiving first-line therapy to identify ESR1 mutations and implement adaptive cancer interception before disease progression. This achievement is a result of long-term strategic collaboration of the companies that led to success of the pivotal Phase III SERENA-6 study where transition of the ctDNA-guided therapies showed 74% increased median progression-free survival (16.0 vs 9.2 months) and 47% decreased risk of global health status worsening.
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Reaffirming the clinical impact of shifting from reactive treatment to proactive ctDNA surveillance, Helmy Eltoukhy, Guardant Health chairman and co-CEO, stated: “This approval represents a landmark shift in how we define disease progression and reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier at a critical moment in a breast cancer patient’s treatment journey.” Representing the 29th global companion diagnostic indication for Guardant360 CDx, this approval reinforces Guardant’s extensive reimbursement footprint across Medicare and commercial payers covering over 300 million lives while establishing circulating tumor DNA monitoring as an essential clinical protocol in precision oncology workflows.