Q3 2025 Revenue of $21.8 million, an increase of 20% over Q3 2024; Q3 2025 gross profit margin of 81%, a 400-basis point improvement from Q3 2024; Raised FY2025 Total Revenue Guidance to $84-86 million; Conference Call and Webcast Today at 4:30 p.m. ET LOUISVILLE, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its financial and operating results for the third quarter ended September 30, 2025. “We delivered a strong third quarte ...

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 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].