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    FDA Clearance and Cardiac Diagnostic Expansion Could Be a Game Changer for QuidelOrtho (QDEL)

    Simply Wall St·11/15/2025 10:26:13
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    • Earlier this month, QuidelOrtho Corporation announced FDA clearance for its VITROS High Sensitivity Troponin assay, reported a quarterly net loss of US$733 million on sales of US$699.9 million, and issued 2025 guidance projecting total revenues between US$2.68 billion and US$2.74 billion.
    • Alongside these financial disclosures, the company highlighted over US$140 million in recent cost savings and a product pipeline expansion into cardiac diagnostics, signaling ongoing efforts to improve efficiency and product mix.
    • We'll explore how the FDA clearance of a key cardiac assay impacts QuidelOrtho's investment outlook amid its operational turnaround.

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    QuidelOrtho Investment Narrative Recap

    For shareholders, the core belief centers on QuidelOrtho’s potential to offset declining COVID testing revenues by expanding into higher-growth diagnostics and improving operational efficiency. While FDA clearance of the new VITROS cardiac assay bolsters the product pipeline and headlines short-term catalysts, its immediate impact on offsetting the persistent post-pandemic revenue drag is limited; persistent losses and shrinking top-line remain the most important risk to monitor. The most relevant recent development is the company’s 2025 revenue guidance of US$2.68 billion to US$2.74 billion, reaffirmed shortly after the VITROS approval. This guidance signals management's expectations despite ongoing normalization pressures, but the guidance band remains below previous highs and reflects ongoing challenges for topline stabilization. In contrast, the rising risk of further product discontinuations reducing future cash flows is something investors should be aware of...

    Read the full narrative on QuidelOrtho (it's free!)

    QuidelOrtho's outlook anticipates $3.0 billion in revenue and $17.2 million in earnings by 2028. This projection is based on an annual revenue growth rate of 2.6% and a $483.6 million increase in earnings from the current level of -$466.4 million.

    Uncover how QuidelOrtho's forecasts yield a $37.67 fair value, a 77% upside to its current price.

    Exploring Other Perspectives

    QDEL Earnings & Revenue Growth as at Nov 2025
    QDEL Earnings & Revenue Growth as at Nov 2025

    Three fair value estimates from the Simply Wall St Community span US$37.67 to US$74.76 per share, highlighting a broad range of expectations. As operational losses persist amid the post-pandemic normalization, you can explore how your own perspective compares within such a wide field of opinions.

    Explore 3 other fair value estimates on QuidelOrtho - why the stock might be worth just $37.67!

    Build Your Own QuidelOrtho Narrative

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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.