Nodify Lung® Nodule Risk Assessment

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Biodesix Recognized as a Thermo Fisher Scientific Center of Excellence (COE) for NGS Diagnostics
Globenewswire· 2025-08-19 13:47
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]
Biodesix Announces Second Quarter 2025 Results and Highlights
Globenewswire· 2025-08-07 20:06
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].
Biodesix to Report Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-24 10:00
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].
Biodesix Announces New Data on the VeriStrat® Test to be Presented at the 2025 ASCO Annual Meeting
Globenewswire· 2025-05-22 21:03
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]
Biodesix to Participate in Upcoming Investor Conferences
GlobeNewswire News Room· 2025-05-21 10:00
Group 1 - Biodesix, Inc. will participate in two upcoming investor conferences: the 22nd Annual Craig-Hallum Institutional Investor Conference on May 28, 2025, and the 45th Annual William Blair Growth Stock Conference on June 4, 2025 [1] - The presentation at the William Blair Growth Stock Conference will be webcast live and available for replay on the company's website [1] Group 2 - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [2] - The company's diagnostic tests, Nodify Lung® and IQLung™, support clinical decisions to expedite personalized care [2] - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions for developing diagnostic tests and therapeutics [2]
Biodesix Announces First Quarter 2025 Results and Highlights
GlobeNewswire News Room· 2025-05-13 20:01
Core Insights - Biodesix, Inc. reported a total revenue of $18.0 million for Q1 2025, marking a 21% increase compared to Q1 2024 [1][3] - The company achieved gross margins of 79.4% in Q1 2025, an improvement from 78.6% in the prior year [3] - Net loss for Q1 2025 was $11.1 million, which is an 18% improvement over the same period last year [3][10] - The revenue guidance for 2025 has been updated to a range of $80-85 million [4] Financial Performance - Diagnostic Testing revenue reached $16.3 million in Q1 2025, an 18% increase year-over-year, driven by a rise in total tests delivered [3] - Development Services revenue surged by 61% to $1.7 million in Q1 2025 compared to the prior year [3] - Operating expenses for Q1 2025 were $23.4 million, a 3% increase from the previous year, primarily due to a $900 thousand rise in Research and Development costs [3] Strategic Initiatives - The company has restructured its sales team into a territory-based model to enhance access to patients with lung nodules, following a successful commercial pilot [2] - Biodesix aims to achieve Adjusted EBITDA positivity in Q4 2025, despite being approximately one quarter behind in its commercial plan [2][4] - The company strengthened its cash position by drawing down $10 million from its term loan facility, raising its pro forma cash balance to $27.6 million [2][10]
Biodesix to Report First Quarter 2025 Financial Results on May 13, 2025
Globenewswire· 2025-04-29 10:00
Core Viewpoint - Biodesix, Inc. will release its financial results for Q1 2025 on May 13, 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 also offers Diagnostic Development Services to biopharmaceutical, life sciences, and research institutions, enhancing their capabilities in developing diagnostic tests and therapeutics [3]
Biodesix partner, Friends of Cancer Research, publishes data in Clinical Cancer Research, demonstrating strong association between ctDNA changes and treatment outcomes for patients with solid tumor types
Newsfilter· 2025-04-23 10:00
Core Insights - The ctMoniTR Project has shown a strong association between changes in circulating tumor DNA (ctDNA) levels and treatment outcomes, indicating potential integration of ctDNA analysis in therapeutic development and clinical cancer care [1][2] - Biodesix and Bio-Rad Laboratories collaborated on this project, utilizing Bio-Rad's Droplet Digital™ PCR technology to detect ctDNA from patient samples [3][4] - Biodesix is actively involved in ctDNA testing and is exploring its combination with proteomics for detecting molecular residual disease (MRD), with advancements to be presented at the upcoming AACR Annual Meeting [4] Company Overview - Biodesix, Inc. is a leading diagnostics solutions company focused on improving clinical care and outcomes for patients, offering diagnostic tests that support personalized care [7] - Bio-Rad Laboratories, Inc. is a leader in life science research and clinical diagnostics, with approximately 7,700 employees and $2.7 billion in revenues in 2023, serving a wide range of customers including universities and biopharmaceutical companies [8]