Biodesix, Inc.

American College of Chest Physicians Publishes New Framework for Lung Nodule Programs Recommending Biomarkers for Risk Stratification

The American College of Chest Physicians published a new framework for building lung nodule programs that names validated biomarker testing, including Biodesix's Nodify Lung tests, as a core component of standardized risk stratification. The framework was developed by a multidisciplinary expert panel and presented at the 2026 CHEST Annual Meeting, the pulmonology community's largest annual gathering. Biodesix CEO Scott Hutton called the inclusion a significant validation of Nodify Lung's clinical decision-making value; the endorsement could support broader adoption in lung nodule programs, though no financial figures were disclosed.

•13d ago

Biodesix Adds Digital Diagnostics to Lung Pipeline, Creating New Growth Platform Combining Blood and Imaging Biomarkers

Biodesix is adding a Digital Diagnostics initiative to its lung strategy, building a multimodal platform combining blood-based biomarkers, imaging biomarkers, and AI. The first product is a radiomics-based lung nodule risk assessment test developed with Vanderbilt University and Vanderbilt Health; initial data will be presented at RSNA on December 3, 2026, with commercial availability anticipated in 2028. The company has IRB approval for the prospective STRATIFY study (NCT07858552) starting Q4 2026, has engaged FDA on a regulatory pathway and Medicare on reimbursement, and is the first diagnostics company named an Industry Affiliate of Vanderbilt's VALIANT AI translation lab.

•13d ago

Biodesix to Present New Real-World Evidence Supporting Integration of Nodify Lung® Testing into Routine Lung Nodule Care at CHEST 2026

Biodesix will present multiple datasets at CHEST 2026 showing real-world integration of its Nodify Lung blood-based lung nodule risk test into routine care pathways. New analyses from the CLARIFY study — which has enrolled more than 2,000 patients in routine practice — include PET imaging comparisons and diagnostic test sequencing, alongside independent research on follow-up adherence and proteomic risk stratification. CEO Scott Hutton said the discussion is shifting from whether blood-based biomarkers can assess risk to how they are routinely incorporated into structured care alongside imaging — evidence of growing clinical adoption for the diagnostics company.

•19d ago

Biodesix Advances Two Complementary Approaches to Molecular Residual Disease (MRD) Monitoring

Biodesix outlined its Molecular Residual Disease strategy for the first time, spanning both tumor-informed and tumor-naive ctDNA monitoring approaches. The tumor-informed solution builds on a multi-year collaboration with Bio-Rad's Droplet Digital PCR, while the tumor-naive methylation-based assay runs on Thermo Fisher's Genexus platform; both will be validated with Memorial Sloan Kettering investigators. The company says the programs extend its focus beyond lung diagnostics into precision oncology, with data presentations planned at the AMP 2026 Annual Meeting in November and the San Antonio Breast Cancer Symposium in December. No revenue figures, contract values, or commercial timelines were disclosed, so near-term financial impact remains speculative.

•1mo ago

Biodesix Announces Second Quarter 2026 Results and Highlights

Biodesix reported Q2 2026 revenue of $26.9 million, a 34% increase year-over-year, driven by a 42% surge in Diagnostic Testing revenue. Gross margin improved to 82%, supported by higher test volumes and better revenue cycle management. The company significantly improved its profitability metrics, narrowing its net loss by 37% and reducing its Adjusted EBITDA loss by 56%. Operating expenses excluding direct costs rose only 7%, demonstrating strong operating leverage. Cash and cash equivalents increased 17% to $30.0 million, supplemented by $6.5 million in ATM proceeds. Management maintained its full-year 2026 revenue guidance of $108 million to $114 million, representing 25% growth at the midpoint.

•2mo ago

Biodesix Announces ATS 2026 Presentations Providing Real-World Clinical Evidence and Healthcare System Economic Value for Nodify Lung® Testing Strategy

Biodesix announced that real-world clinical and economic data for its Nodify Lung testing strategy will be presented at the upcoming ATS 2026 Annual Meeting. CEO Scott Hutton stated the presentations highlight the clinical value and economic advantages of their lung nodule management programs, noting accelerating adoption by medical centers. The company will exhibit at booth #1327 during the conference in Orlando, FL from May 15-20.

•5mo ago

Biodesix Announces First Quarter 2026 Results and Highlights

Biodesix reported strong Q1 2026 results with revenue growing 42% year-over-year to $25.6 million, driven by a 29% increase in test volumes and a doubling of Development Services revenue. Gross margin was 84% (82% excluding a one-time tax recovery), and the company raised its full-year 2026 revenue guidance to $108-114 million, representing 25% growth at the midpoint. Adjusted EBITDA loss improved by 35% to $4.1 million, while cash position increased to $25.6 million, bolstered by $16.8 million in at-the-market proceeds.

•5mo ago