FDA Approves New Colorectal Cancer Use For Guardant360 Might Change The Case For Investing In Guardant Health (GH)

Simply Wall St.01-24

Earlier this week, Guardant Health received FDA approval for its Guardant360 CDx liquid biopsy as a companion diagnostic to identify BRAF V600E-mutant metastatic colorectal cancer patients eligible ...

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This marks the test’s first approval in colorectal cancer and its 25th companion diagnostic indication overall, underscoring the expanding role of non-invasive genomic profiling in tailoring treatment when tissue samples are unavailable or insufficient. Next, we’ll examine how this new colorectal cancer companion diagnostic indication shapes Guardant Health’s investment narrative, particularly around expanding clinical utility. These 9 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.AdvertisementWhat Is Guardant Health's Investment Narrative?To own Guardant Health, you need to believe that liquid biopsies and blood-based cancer screening can become embedded in everyday oncology and primary care, and that Guardant’s platform will capture a meaningful share of that testing volume despite ongoing losses and a rich sales multiple. The new colorectal cancer companion diagnostic approval fits that thesis neatly, reinforcing Guardant360’s role in real-world treatment selection and marginally strengthening near-term oncology testing demand, but it does not fundamentally change the main catalysts, which still sit with Shield screening uptake and broader Infinity-driven pharma work like the new Merck collaboration. The biggest risks remain execution and capital intensity: turning rapid revenue growth and high R&D spend into sustainable, cash-generating scale while justifying a valuation that already prices in a lot of success. Yet one core risk remains easy to miss and could matter more than the headlines suggest. Guardant Health's shares have been on the rise but are still potentially undervalued by 35%. Find out what it's worth.Exploring Other PerspectivesGH 1-Year Stock Price Chart Four Simply Wall St Community valuations span roughly US$68 to about US$176 per share, with some members seeing the stock as significantly overvalued and others quite the opposite. Set that against Guardant’s ongoing losses and heavy investment needs discussed above, and you can see why views on how the story ultimately plays out vary widely, making it worth comparing several of those alternative viewpoints before forming your own stance.Explore 4 other fair value estimates on Guardant Health - why the stock might be worth as much as 54% more than the current price!Build Your Own Guardant Health NarrativeDisagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.A great starting point for your Guardant Health research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.Our free Guardant Health research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Guardant Health's overall financial health at a glance.Interested In Other Possibilities?The market won't wait. These fast-moving stocks are hot now. Grab the list before they run:Trump's oil boom is here - pipelines are primed to profit. Discover the 22 US stocks riding the wave.This technology could replace computers: discover 23 stocks that are working to make quantum computing a reality.The end of cancer? These 29 emerging AI stocks are developing tech that will allow early identification of life changing diseases like cancer and Alzheimer's.  This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: Manage All Your Stock Portfolios in One PlaceWe've created the ultimate portfolio companion for stock investors, and it's free.• Connect an unlimited number of Portfolios and see your total in one currency• Be alerted to new Warning Signs or Risks via email or mobile• Track the Fair Value of your stocksTry a Demo Portfolio for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. 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