FDA Grants Approval for Guardant Health’s Blood-Based Diagnostic to Support Targeted Therapy in Advanced Colorectal Cancer

Guardant Health Inc. recently achieved FDA approval for its Guardant360 CDx assay as a companion diagnostic tool in the management of metastatic colorectal cancer (mCRC) patients harboring the BRAF V600E mutation. This pivotal regulatory milestone endorses the use of Guardant360 CDx to identify individuals who may derive clinical benefit from the therapeutic regimen combining encorafenib (marketed as Braftovi) with cetuximab and chemotherapy. The FDA’s decision is supported by pivotal data originating from Pfizer’s Phase 3 BREAKWATER trial, which evaluated the efficacy of this combination therapy in treating mCRC. The clinical study demonstrated that the addition of encorafenib and cetuximab to mFOLFOX6 chemotherapy elicited statistically significant improvements in several efficacy endpoints, including objective response rate, progression-free survival, and overall survival, when compared with the existing standard of care treatments. Guardant360 CDx distinguishes itself as the first FDA-sanctioned liquid biopsy platform offering comprehensive genomic profiling across a spectrum of solid tumors. Apart from its newly established role in colorectal cancer, it holds companion diagnostic approval for therapies addressing non-small cell lung cancer and breast cancer. Its innovative approach utilizes a simple blood draw to detect multiple genomic alterations such as the BRAF V600E mutation and other clinically pertinent genetic markers. This non-invasive technique enables oncologists to promptly and reliably identify suitable patients for specific FDA-approved targeted therapies, particularly in scenarios where tumor tissue samples are either unavailable, insufficient, or where rapid initiation of therapy is clinically warranted. Colorectal cancer remains the second most fatal cancer in the United States, with the BRAF V600E mutation accounting for approximately 8 to 10 percent of mCRC cases, a subgroup associated with a more aggressive disease course and poorer prognosis. The approval of Guardant360 CDx for this indication now marks its 25th companion diagnostic indication, highlighting an expanding footprint across various tumor types. Furthermore, the test benefits from extensive reimbursement coverage, including Medicare and commercial payers, protecting over 300 million lives, thereby enhancing patient access to this advanced diagnostic method. In the commercial sphere, Guardant Health recently entered a multi-year strategic alliance with Merck & Co. to integrate Guardant’s Infinity Smart platform in the development and commercialization of Merck’s oncology products, reflecting growing collaboration and confidence in the diagnostic’s utility. Financially, the company reported preliminary fourth-quarter 2025 revenues reaching $280 million, signifying a 39% increase year-over-year, with total annual sales for 2025 surging 33% to $981 million. These gains are primarily propelled by rising demand in its oncology and cancer screening volumes. From an investment perspective, Guardant Health’s equity exhibits strong technical momentum. The stock is currently valued 10% above its 20-day moving average and approximately 38% higher than its 100-day moving average, signaling robust short-term performance. Over the past year, the stock price has appreciated by roughly 145%, trading near its 52-week high at the time of reporting. Technical indicators reflect mixed but cautiously optimistic momentum, with the Relative Strength Index (RSI) at 68.24—classified as neutral—and the Moving Average Convergence Divergence (MACD) positioned above its signal line, suggesting bullish inclination. Analysts closely watch Guardant Health’s upcoming earnings announcement scheduled for February 19, 2026. Market expectations call for a per-share loss of $0.61, a slight improvement from the prior year’s $0.62 loss, alongside a revenue forecast climbing to $273.83 million from $201.81 million year-over-year. The consensus maintains a Buy rating on the stock, with an average price target of $87.25, indicative of positive investor sentiment. Guardant Health’s position is further underscored by a favorable momentum score from Benzinga Edge (97.64), reflecting its strong outperformance relative to the broader market. Nonetheless, investors are advised to maintain vigilance as they await forthcoming financial disclosures that could influence the stock’s trajectory. In summary, the FDA’s approval of Guardant360 CDx as a companion diagnostic for BRAF V600E-mutant metastatic colorectal cancer represents a significant advancement in precision oncology. By offering a less invasive and expedient testing modality, it facilitates more informed and timely treatment selection, potentially improving outcomes for a subset of colorectal cancer patients facing limited options.