Guardant Health Inc. (GH) just scored a significant FDA win that could change how doctors treat advanced colorectal cancer. On Thursday, regulators approved the company's Guardant360 CDx test as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who might benefit from treatment with Braftovi (encorafenib) combined with cetuximab and chemotherapy.

Here's why this matters: instead of requiring an invasive tissue biopsy, doctors can now use a simple blood draw to detect the BRAF V600E mutation and other clinically relevant genetic alterations. That's particularly valuable when tumor tissue is unavailable, insufficient, or when you need to start treatment quickly.

The Science Behind the Approval

The accelerated approval for Braftovi was backed by data from Pfizer Inc.'s (PFE) Phase 3 BREAKWATER trial. The study demonstrated that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free survival, and overall survival compared with standard care.

Guardant360 CDx holds the distinction of being the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and now serves as an approved companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

Why This Approval Matters

Colorectal cancer remains the second-leading cause of cancer-related deaths in the United States. BRAF V600E mutations show up in approximately 8 to 10% of metastatic colorectal cancer cases, making this a high-risk patient population that needs better diagnostic options.

The latest FDA approval marks the 25th companion diagnostic indication for Guardant360 CDx across multiple tumor types. The platform now enjoys broad coverage by Medicare and commercial payers, representing more than 300 million covered lives—which means patients can actually access the test without paying out of pocket.

Guardant360 CDx essentially expands access to non-invasive genomic testing for patients who need it most. Using a simple blood draw helps clinicians quickly identify patients eligible for FDA-approved treatments, enabling timely treatment decisions when every day counts.

Building Momentum

This approval doesn't exist in a vacuum. Earlier this week, Guardant Health announced a multi-year collaboration with Merck & Co. Inc. (MRK) to support the development and commercialization of Merck's oncology portfolio using the Guardant Infinity Smart platform.

Last week, the company released preliminary fourth quarter 2025 revenues of $280 million, up 39% year over year. Full-year 2025 sales climbed 33% to $981 million, driven by oncology and shield screening volume. Those aren't just good numbers—they're validation that the company's technology is gaining real traction in clinical practice.

The Stock Story

Investors have noticed. The stock is currently trading 10% above its 20-day simple moving average and 37.8% above its 100-day simple moving average, indicating strong short-term momentum. Over the past 12 months, shares have increased by 145.23% and are currently positioned closer to their 52-week highs than lows.

From a technical perspective, the RSI sits at 68.24, which is considered neutral territory, while the MACD is above its signal line, indicating bullish momentum. The combination suggests mixed momentum with potential for continued strength.

What's Next

Investors are looking ahead to the company's next earnings report on February 19, 2026. Analysts expect a loss of $(0.61) per share, slightly improved from $(0.62) a year ago, and revenue of $273.83 million, up from $201.81 million from the same quarter last year.

The stock carries a Buy rating among analysts with an average price target of $87.25, reflecting positive sentiment as investors monitor performance ahead of the earnings release.

Performance Scorecard

Looking at Guardant Health's momentum profile compared to the broader market, the stock scores 97.64 on momentum indicators—which is about as bullish as it gets. The stock is clearly outperforming the broader market on this metric.

The verdict? Guardant Health shows a strong momentum setup. While the high momentum score indicates robust performance, investors should remain cautious as they await further earnings updates and watch how the new FDA approval translates into commercial revenue.

Price Action: Guardant Health shares were up 2.27% at $118.37 at the time of publication on Thursday, trading at a new 52-week high.