Guardant Health received FDA approval for its Guardant360 CDx as a companion diagnostic to guide use of Pfizer’s Braftovi‑cetuximab chemotherapy regimen for BRAF V600E colorectal cancer, while a separate federal appeals court remanded a patent damages case involving Guardant and TwinStrand to the Patent Trial and Appeal Board (PTAB). The dual developments affect Guardant’s commercial positioning and legal liabilities concurrently. The FDA decision expands Guardant360 CDx’s companion diagnostics footprint and reinforces use of circulating tumor DNA (ctDNA) to select targeted therapies in metastatic colorectal cancer, citing BREAKWATER trial data. Separately, the U.S. Court of Appeals asked the PTAB to revisit the validity analysis for one of TwinStrand’s duplex sequencing patents, a move described by analysts as an incremental positive that could reduce Guardant’s potential damages exposure.