Estimated Q4 2025 Revenue of $28.8 million, an increase of 41%; Grew full-year revenue to an estimated $88.5 million, an increase of 24%; Affirms guidance of Adjusted EBITDA positivity in Q4 2025. LOUISVILLE, Colo., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX) (the company), a leading diagnostic solutions company, today announced its preliminary financial results for the fourth quarter and year ended December 31, 2025 (fiscal 2025). The financial results included in this release pertainin ...

Core Insights - Biodesix, Inc. reported a strong third quarter for 2025 with revenue of $21.8 million, reflecting a 20% increase compared to Q3 2024 [1][2] - The company improved its gross profit margin to 81%, marking a 400-basis point enhancement year-over-year [1][2] - Biodesix raised its total revenue guidance for FY2025 to a range of $84 million to $86 million [1][6] Financial Results - Total revenue for Q3 2025 was $21.8 million, a 20% increase from the prior year [5] - Lung Diagnostic Testing revenue reached $19.8 million, up 16% year-over-year, driven by increased tests delivered and higher average revenue per test [5] - Development Services revenue surged to $1.9 million, a 97% increase year-over-year, attributed to fulfilling contracted business and securing new agreements [5] - Gross margin was $17.7 million, or 81%, reflecting a 400-basis point improvement due to growth in Lung Diagnostic testing and cost optimizations [5] - Operating expenses for Q3 2025 were $24.7 million, a 10% increase from the previous year, primarily due to higher sales and marketing costs [5] - The net loss for Q3 2025 was $8.7 million, an improvement of 15% compared to the same period last year [5] - Adjusted EBITDA loss was $4.6 million, an 18% improvement year-over-year [5] Business Highlights - Lung Diagnostic Tests ordered in primary care increased by over 75% compared to Q3 2024 [12] - The Development Services business reported $12.9 million under contract, a 16% increase year-over-year [12] - Biodesix expanded its partnership with Bio-Rad Laboratories to develop high complexity assays [12] - A Research and Development Corporate Workshop is scheduled for November 12, focusing on the company's R&D efforts and partnerships [12]

Core Insights - Biodesix, Inc. will present its Corporate and Scientific updates at the 2025 AMP Annual Meeting in Boston from November 12-15, highlighting its diagnostic solutions and strategic partnerships [1][2]. Group 1: Corporate Workshop - A workshop led by Dr. Gary Pestano will focus on Biodesix's R&D Roadmap, showcasing both near- and long-term diagnostic services [2]. - Key partners such as Memorial Sloan Kettering Cancer Center, Bio-Rad Laboratories, and Thermo Fisher Scientific will provide updates during the workshop [2]. Group 2: Molecular Testing Approaches - The workshop will emphasize new approaches to comprehensive molecular testing, aiming for accurate results with rapid turnaround, high throughput, and low sample requirements [3][4]. - Advances in molecular diagnostic technologies, including NGS, ddPCR, and Mass Spectrometry, will be discussed, along with their clinical utility and research concepts for monitoring therapeutic responses [4]. Group 3: Company Overview - Biodesix is dedicated to enhancing clinical care and outcomes for patients, particularly in lung disease, through its diagnostic tests like Nodify Lung® and IQLung® [7]. - The company provides Development Services to biopharmaceutical and life sciences institutions, supporting the development of diagnostic tests and therapeutics [7]. Group 4: Presentation and Engagement - A poster presentation on the impact of blood collection tubes on a novel device for enriching circulating tumor cells will be presented by Leisa Jackson on November 15 [6]. - Biodesix executives and experts will be available at booth 647 to discuss the company's offerings during the AMP Annual Meeting [5].

Core Insights - Biodesix has signed an expanded partnership agreement with Bio-Rad to develop and clinically validate the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing [1][2][4] - The assay will enable highly sensitive detection and quantification of multiple ESR1 mutations from ctDNA samples, which is critical for HR+/HER2- advanced breast cancer treatment [2][3] - Biodesix plans to offer the validated assay as a test service at its accredited CLIA-CAP laboratory and will seek reimbursement through the Centers for Medicare & Medicaid Services (CMS) [3] Company Developments - The first assay to be validated under the agreement is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay, which is essential for the new generation of therapies known as oral selective estrogen receptor degraders (SERDs) [2] - Biodesix aims to improve clinical care and outcomes for patients through its diagnostic solutions, including the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance [5] Market Impact - The emergence of ESR1 mutations as biomarkers for breast cancer has significantly increased global demand for rapid and sensitive assays in the oncology market [4] - The collaboration between Biodesix and Bio-Rad is expected to enhance access to sensitive biomarker detection for advanced breast cancer, addressing clinical needs with speed and precision [4] Upcoming Events - Both companies will present more details on their R&D visions, partnerships, and commercial roadmaps at the upcoming AMP conference scheduled for November 11-15 in Boston, MA [4]

Core Viewpoint - Biodesix, Inc. will participate in Lake Street Capital Markets' 9th Annual Best Ideas Growth (BIG9) Conference, with CFO Robin Cowie hosting in-person 1x1 investor meetings on September 11, 2025 [1]. Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients [2]. - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which assist in clinical decision-making for lung disease [2]. - Biodesix Development Services support biopharmaceutical and life sciences institutions in developing diagnostic tests, tools, and therapeutics [2].

Core Insights - Biodesix has been designated as a Thermo Fisher Scientific Center of Excellence (COE), enhancing its role in advancing NGS-based diagnostics for solid tumors [1][2] - The collaboration with Thermo Fisher has led to the validation of the Oncomine Dx Express Test, which is crucial for the FDA approval of the Genexus Dx Integrated Sequencer [2][3] - Biodesix aims to expand its molecular diagnostic and NGS testing capabilities, particularly in tissue-based profiling, as part of its commitment to improving cancer diagnosis and care [3] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung Cancer Treatment Guidance, which support personalized care [4] - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions [4] Thermo Fisher COE Network - The Thermo Fisher NGS COE Network collaborates with global institutions to develop and refine the Ion Torrent™ Oncomine™ solutions portfolio [5] - This network aims to accelerate oncology research and advance precision medicine through strategic alliances [5]

Core Viewpoint - Biodesix, Inc. reported strong financial results for Q2 2025, with a revenue increase of 12% year-over-year, reaching $20.0 million, and reaffirmed its full-year revenue guidance of $80-85 million [1][6]. Financial Performance - Q2 2025 revenue was $20.0 million, a 12% increase compared to Q2 2024 [1][4]. - Gross profit margin for Q2 2025 was 80%, reflecting a 150-basis point improvement from the previous year [1][11]. - Development Services revenue grew by 53% year-over-year, reaching $2.1 million [5][20]. - Lung Diagnostic Testing revenue was $17.9 million, an 8% increase from the prior year, driven by an increase in total tests delivered [5][20]. - Adjusted EBITDA loss for Q2 2025 was $7.2 million, a 29% increase in loss compared to the same period last year [11][22]. Business Highlights - The sales team expanded to an average of 74 representatives, a 21% increase from the previous year [5]. - Primary care ordering of lung diagnostic tests increased over 100% compared to pre-pilot program levels in 2024 [5]. - The company achieved an all-time high in development services business dollars under contract, totaling $12.5 million, up 54% year-over-year [5]. - Digital ordering initiatives saw a 63% increase over the prior year [5]. - The company reached patient enrollment requirements for its ALTITUDE trial in July 2025 [5]. Future Outlook - The company is positioned to achieve Adjusted EBITDA positivity in Q4 2025, supported by sales team expansion and operational effectiveness [2]. - Biodesix maintains confidence in achieving its full-year revenue guidance of $80-85 million, indicating a focus on sustainable long-term growth [2][6].

Company Overview - Biodesix, Inc. is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients [3] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which aid in clinical decision-making for lung disease [3] Upcoming Event - Scott Hutton, CEO, and Robin Cowie, CFO, will present in a fireside chat and conduct in-person 1x1 investor meetings at the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025 [1] - The fireside chat is scheduled for 4:30 PM ET and will be held in Boston, MA [2] - The presentation will be available for live webcast and replay on the company's website [2]

Core Viewpoint - Biodesix, Inc. will release its financial results for Q2 2025 on August 7, 2025, and will host a conference call to discuss these results and provide a business update [1]. Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [3]. - The company markets diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which support clinical decisions for personalized care [3]. - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions, aiding in the development of diagnostic tests and therapeutics [3].

Core Insights - New data from the INSIGHT study indicates that the VeriStrat Host Immune Classifier can predict overall survival in non-small cell lung cancer patients treated with immunotherapy [1][2] - The presentation of this data will occur at the 2025 ASCO Annual Meeting, highlighting the significance of the findings [1] Group 1: Study Findings - The VeriStrat test categorizes patients' immune responses as either Hot (VeriStrat Good) or Cold (VeriStrat Poor) [2] - Statistically significant improvement in overall survival was observed in patients with a VeriStrat Poor result when treated with immunotherapy combined with chemotherapy, compared to those receiving immunotherapy alone [2] - The two-year survival rate for patients receiving the combination treatment was over three times higher than for those on immunotherapy alone [2] Group 2: Clinical Implications - The VeriStrat test may assist oncologists in evaluating treatment benefits and risks, potentially guiding decisions on treatment escalation or de-escalation [3] - Preliminary results from another ongoing study suggest that the VeriStrat test may also be applicable for other solid tumors, with data expected to be published later in 2025 [3] Group 3: Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance to support personalized care [4]