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Biodesix reported Q3 2025 revenue of $21.8 million, a 20% year-over-year increase, driven by robust demand for lung cancer diagnostic tests and higher average revenue per test. The company's gross profit margin improved to 81%, a 400-basis point increase from Q3 2024, reflecting streamlined workflows and cost optimization. While
posted a net loss of $8.7 million for the quarter, it remains on track to achieve Adjusted EBITDA positivity in Q4 2025, a critical milestone for investor confidence.The company raised its full-year 2025 revenue guidance to $84–86 million, up from prior estimates, citing strong momentum in primary care expansion and development services. However, cash and equivalents stood at $16.6 million as of September 30, 2025, with a $5.2 million increase in accounts receivable highlighting potential liquidity risks if collections lag.
Biodesix's
to develop Droplet Digital™ PCR (ddPCR™) assays represents a transformative step in precision oncology diagnostics. The partnership focuses on high-complexity assays for detecting genomic markers, with the ddPLEX ESR1 Mutation Detection Assay as a flagship product. This assay enables highly sensitive detection of ESR1 mutations in circulating tumor DNA (ctDNA), critical for guiding treatment with oral selective estrogen receptor degraders (SERDs) in HR+/HER2- advanced breast cancer.The ESR1 assay, validated for clinical use, will be offered as a test service at Biodesix's CLIA-CAP accredited laboratory, targeting both biopharma customers and clinical monitoring. The company is actively pursuing CMS reimbursement for the assay, a strategic move to ensure accessibility and scalability. This innovation aligns with industry trends favoring liquid biopsies and personalized treatment pathways, positioning Biodesix to capture a larger share of the $5.2 billion global liquid biopsy market.

Biodesix's Q3 2025 results also highlight its aggressive expansion into primary care and pulmonologist referral networks, which drove a 100% increase in lung diagnostic test orders compared to the prior year, as reported in the company's
. The company's sales team grew by 21%, reaching an average of 74 representatives, while digital ordering integration with electronic medical records surged by 63%, enhancing operational efficiency.The development services segment saw a 53% year-over-year revenue increase, with dollars under contract hitting an all-time high of $12.5 million. This segment, which includes assay development for biopharma clients, is a key growth driver, as it diversifies revenue streams and reduces reliance on clinical testing alone. Additionally, Biodesix's involvement in the ALTITUDE trial and pipeline initiatives like genomic and proteomic minimal residual disease (MRD) tests underscores its commitment to R&D-driven differentiation.
The precision oncology diagnostics market is poised for sustained growth, driven by advancements in next-generation sequencing (NGS), liquid biopsies, and AI-driven data analytics. Biodesix's focus on high-sensitivity assays and strategic partnerships positions it to capitalize on these trends. The ESR1 assay, for instance, addresses a $1.2 billion opportunity in breast cancer diagnostics alone, with SERDs projected to become a $3 billion market by 2030.
However, challenges remain. Reimbursement hurdles, regulatory scrutiny, and competition from NGS-focused players like Guardant Health and Tempus could test Biodesix's margins. That said, its ddPCR technology offers a unique value proposition in detecting low-frequency mutations, a niche where NGS struggles with sensitivity.
Biodesix's Q3 2025 performance and strategic initiatives reflect a company in transition-from a diagnostics provider to a diversified precision oncology innovator. With revenue growth, margin expansion, and a robust R&D pipeline, Biodesix is well-positioned to achieve Adjusted EBITDA positivity and sustain long-term value creation. Investors should monitor its progress in securing CMS reimbursement for the ESR1 assay and scaling digital ordering capabilities, both of which could catalyze broader adoption and profitability.
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