• Earlier in June 2026, Guardant Health announced that the FDA approved its Guardant360 CDx liquid biopsy as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS, the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer as an initial treatment option.
• This 27th companion diagnostic indication extends Guardant360 CDx across more tumor types and leverages its broad payer coverage of more than 300 million lives, potentially reinforcing its role in blood-based precision oncology.
• We’ll now examine how this added companion diagnostic indication, particularly its link to a first-in-class HER2-mutant NSCLC therapy, affects Guardant Health’s investment narrative.

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Guardant Health Investment Narrative Recap

To own Guardant Health, you need to believe that its liquid biopsy and screening platforms can scale from high R&D spending and net losses into a durable precision oncology franchise. The new Guardant360 CDx indication for HERNEXEOS reinforces the test’s clinical role, but does not by itself change the near term focus on reducing cash burn and managing reimbursement risk around Shield and oncology testing volumes.

The most relevant recent announcement is the May 2026 FDA approval of Guardant360 Liquid CDx, a broader multiomic version of Guardant360 with fast turnaround and extensive payer coverage. Together with the new HER2 mutant NSCLC companion use, these approvals broaden Guardant’s CDx footprint, which could support test volumes that underpin its raised 2026 revenue guidance of US$1.30–1.32 billion while the company continues to absorb substantial R&D and SG&A costs.

But while this progress in companion diagnostics is encouraging, investors should also be aware that...

Guardant Health's narrative projects $2.3 billion revenue and $4.4 million earnings by 2029.

Uncover how Guardant Health's forecasts yield a $135.76 fair value, a 7% upside to its current price.

Exploring Other Perspectives

Some of the most pessimistic analysts were assuming revenue of about US$1.7 billion by 2029 and still no profitability, which is far more cautious than narratives that lean on broad based test adoption and improving margins, so this new companion diagnostic approval could lead you to revisit how conservative or optimistic those older assumptions really were.

Explore 6 other fair value estimates on Guardant Health - why the stock might be worth as much as 28% more than the current price!

Decide For Yourself

Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts.

• A great starting point for your Guardant Health research is our analysis highlighting 2 key rewards and 2 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.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data 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 financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.