Biodesix

What Biodesix does

Biodesix is a publicly traded (NASDAQ: BDSX) diagnostic solutions company headquartered in Louisville, Colorado that develops and commercializes blood-based diagnostic tests for lung disease along with custom development services for the biopharmaceutical industry. The company's clinical product portfolio is organized into two main lines: Nodify Lung (Nodify CDT and Nodify XL2), which stratifies malignancy risk for patients with pulmonary nodules to guide biopsy-versus-surveillance decisions, and IQLung (VeriStrat, GeneStrat ddPCR, and GeneStrat NGS), which provides immune profiling and tumor genotyping for non-small cell lung cancer treatment guidance. The underlying technology is a multi-omic platform combining proteomic methods (MALDI-TOF mass spectrometry with proprietary machine learning interpretation) and genomic methods (Droplet Digital PCR and Next Generation Sequencing on Thermo Fisher's Ion Torrent Genexus Dx), with outputs produced by validated algorithms integrating biomarker data with clinical and radiological risk factors.

The company generates revenue through two streams. The first is direct diagnostic testing sold via a field sales force (averaging 74 representatives) to pulmonologists, thoracic surgeons, oncologists, hospitals, and increasingly primary care physicians, with tests priced on a per-unit basis ($1,085 for Nodify CDT up to $4,855 for GeneStrat NGS) and reimbursed through Medicare, Medicaid, and commercial insurance. The second is biopharmaceutical and life sciences development services — assay development, biomarker discovery, clinical sample testing, regulatory support, and sample logistics — sold to 65+ industry clients including 8 of the top 10 pharmaceutical companies. FY2025 revenue was $88.5M (24% YoY growth), Q1 2026 revenue was $25.6M (+42% YoY), and the company achieved its first quarter of positive Adjusted EBITDA ($530K) in Q4 2025, supported by gross margins of 82-83%. Recent strategic moves include an October 2025 expanded partnership with Bio-Rad to enter breast cancer diagnostics (ddPLEX ESR1) and an MSK Cancer Center research collaboration for novel biomarker and MRD test development.

Name

Biodesix

Legal name

Biodesix, Inc.

Website

https://biodesix.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

251–500 employees

Short description

Biodesix (NASDAQ: BDSX) is a diagnostic solutions company that develops blood-based multi-omic tests for lung nodule risk assessment and lung cancer treatment guidance, and provides assay development and biomarker services to biopharmaceutical companies.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ)

Keywords

• Lung cancer diagnostics
• Proteomic blood tests
• Biopharma development services
• Companion diagnostics
• Clinical laboratory services

Headquarters

HQ city

Broomfield

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Testing: Revenue from sales of blood-based diagnostic tests for lung nodule risk assessment (Nodify CDT, Nodify XL2) and lung cancer treatment guidance (VeriStrat, GeneStrat ddPCR, GeneStrat NGS). Tests are ordered by healthcare providers and billed to insurance or patients.
2. Development Services: Custom development services for biopharmaceutical, life sciences, and academic research institutions. Includes assay development, biomarker discovery, clinical sample testing, regulatory support, and sample logistics. Revenue from contract testing services with 65+ industry clients and academic partners including 8 of top 10 pharmaceutical companies.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Biodesix develops and performs blood-based diagnostic tests for lung disease in its CLIA-certified, CAP-accredited, NYS CLEP-approved, and ISO 13485-certified laboratories, organized into two product lines: Nodify Lung (Nodify CDT and Nodify XL2) for lung nodule risk assessment, and IQLung (VeriStrat, GeneStrat, GeneStrat NGS) for non-small cell lung cancer treatment guidance. The company also sells custom diagnostic development services to biopharmaceutical, life sciences, and academic clients, including assay development, biomarker discovery, validation, clinical sample testing, and regulatory support.

Product overview

Biodesix is a diagnostic solutions company offering both diagnostic tests and diagnostic development services through a unified platform approach. The diagnostic testing portfolio consists of two main product lines: Nodify Lung® Nodule Risk Assessment (including Nodify CDT® and Nodify XL2® blood-based proteomic tests for lung nodule management) and IQLung® Cancer Treatment Guidance (including VeriStrat® immune profiling, GeneStrat® ddPCR tumor profiling, and GeneStrat NGS® 52-gene panel for NSCLC treatment decisions). The company provides Development Services including Biopharma Services and Life Sciences Services, enabling biopharmaceutical, life sciences, and research institutions with capabilities spanning translational research, biomarker discovery, assay development and validation, clinical sample testing, and regulatory/commercialization support. Biodesix operates two CAP-accredited, CLIA-certified, NYS CLEP-approved, and ISO 13485-certified U.S. laboratories.

Differentiator

Problem solved

Functional benefit

Brands

• Nodify Lung: Blood-based lung nodule risk assessment tests including Nodify CDT and Nodify XL2
• IQLung
• GeneStrat
• VeriStrat

Products and services

• Nodify CDT Test Blood-based proteomic test measuring seven circulating autoantibodies (P53, NY-ESO-1, CAGE, GBU4-5, SOX2, HuD, and MAGE A4) associated with lung cancer to help physicians identify patients with suspicious lung nodules that may be malignant. Reports 'High Level', 'Moderate Level', or 'No Significant Levels of Antibodies Detected (NSLAD)'. Validated for patients aged 40 and older with nodules 4–30mm. Results available in one business day.
• Nodify XL2 Test Blood-based proteomic test measuring the ratio of two peptides (LG3BP and C163A) combined with five clinical risk factors to identify lung nodules likely benign or at reduced risk of being cancerous. Reports 'Likely Benign', 'Reduced Risk', or 'Indeterminate'. Demonstrated 74% reduction in unnecessary invasive procedures in the ORACLE study. Results available in five business days.
• VeriStrat Test Blood-based proteomic test providing a personalized view of each patient's immune response to cancer by measuring eight protein features using MALDI-ToF mass spectrometry interpreted by a proprietary machine learning algorithm. Produces 'VeriStrat Good' or 'VeriStrat Poor' result. Studied in 85+ peer-reviewed clinical studies showing predictive and prognostic value independent of PD-L1 expression.
• GeneStrat Test Blood-based tumor profiling test detecting guideline-recommended actionable mutations in lung cancer: EGFR, KRAS, BRAF, EML4-ALK, ROS-1, and RET. Uses Droplet Digital PCR (ddPCR) technology achieving 97% tissue concordance and 100% specificity. Results available in three business days.
• GeneStrat NGS Test Blood-based 52-gene tumor profiling panel detecting guideline-recommended actionable mutations in advanced NSCLC, including SNV, INDELS, CNA, fusions, and exon-skipping variants. Targets include EGFR, KRAS, BRAF, EML4-ALK, ROS-1, RET, MET, NTRK. Powered by Thermo Fisher's Oncomine Dx Express Test on Ion Torrent Genexus Dx Integrated Sequencer.
• Biopharma Services Comprehensive molecular diagnostic services for biopharmaceutical companies including cfDNA/cfRNA testing and monitoring, discovery proteomics, targeted proteomics, and sample logistics. Services support clinical trial enrollment, therapeutic dosage optimization, efficacy measurement, and resistance mutation monitoring. Available to 65+ industry clients and academic partners including 8 of top 10 pharmaceutical companies.
• Life Sciences Services Development services for life sciences partners including development, scale, and commercialization of IVD and LDT tests with specimen kitting and transport operations. Services include translational research, biomarker discovery, assay design and validation, regulatory expertise, and reimbursement support.
• Biodesix Development Services End-to-end diagnostic development services including translational research, biomarker discovery, assay design, development and validation, clinical sample testing, regulatory and reimbursement support, and commercialization services. Operates CAP-accredited, CLIA-certified, NYS CLEP-approved, and ISO 13485-certified laboratories.
• Biodesix Access Program Comprehensive billing services and affordability options for patients including eligibility and benefits verification, prior authorizations, claims billing, denial management and appeals, interest-free payment plans, and financial assistance for qualifying patients.
• ddPLEX ESR1 Mutation Detection Highly sensitive Droplet Digital PCR (ddPCR) assay for detection of ESR1 mutations in breast cancer. Developed under the expanded Biodesix–Bio-Rad Laboratories partnership for oncology applications including clinical and biopharmaceutical use.

Quantifiable outcome

• 74% relative reduction in unnecessary invasive procedures on benign nodules
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature5 records

Partnerships

Four partnerships are on record, tiered core.

• Bio-Rad LaboratoriescoreStrategic or Co-development Partner · 22 October 2025Expanded partnership to develop and validate highly sensitive ddPCR assays for oncology. First assay ddPLEX ESR1 Mutation Detection targets breast cancer biomarkers. Leverages Bio-Rad's Droplet Digital PCR technology for clinical and biopharma applications.
• Memorial Sloan Kettering Cancer Center (MSK)coreStrategic or Co-development Partner · 25 March 2024Master Collaborative Research Agreement (MCRA) for diagnostic test development aimed at improving cancer treatment. Biodesix utilizing genomics, proteomics, and data mining capabilities to develop and commercialize oncology biomarker assays with MSK.
• Memorial Sloan Kettering Cancer Center (MSK)coreStrategic or Co-development Partner · 3 June 2022Initial master sponsored research agreement (MSRA) announced for development of novel molecular MRD test. MSRA also includes potential future development of other diagnostic tests for cancer treatment improvement.
• Thermo Fisher ScientificcoreTechnology or IntegrationPartnership for Next Generation Sequencing powered by Thermo Fisher technology. Biodesix was first lab to offer testing using Thermo Fisher's Oncomine Dx Express Test on Ion Torrent Genexus Dx Integrated Sequencer. Collaboration on MRD monitoring tests.

Scale indicators20 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Guardant Health: Guardant Health offers liquid biopsy tests including Guardant360 CDx for comprehensive genomic profiling in advanced cancer, including NSCLC. It is the most direct competitor to Biodesix's GeneStrat and GeneStrat NGS tests in blood-based tumor profiling for lung cancer treatment guidance.
• Veracyte: Veracyte provides genomic diagnostics in pulmonology (Percepta), urology (Decipher), and thyroid/breast, with a multi-omic platform approach. Veracyte directly competes in lung nodule management and shares Biodesix's blood- and tissue-based diagnostic strategy in oncology.
• NeoGenomics: NeoGenomics operates a CLIA-certified oncology-focused clinical laboratory offering comprehensive tumor profiling, liquid biopsy, and pharma services. Like Biodesix, it serves both clinical oncologists and biopharma clients with molecular diagnostics and clinical trial support.
• Natera: Natera offers Signatera, a leading tumor-informed minimal residual disease (MRD) test, alongside oncology and organ health diagnostics. Natera competes with Biodesix in blood-based oncology testing and represents a direct competitor in the MRD space that Biodesix is entering with Thermo Fisher.

Broad incumbents

• Foundation Medicine: Foundation Medicine, a Roche subsidiary, provides FoundationOne CDx and FoundationOne Liquid CDx — the leading FDA-approved comprehensive genomic profiling tests for solid tumors including NSCLC. It is a broad incumbent whose scale, FDA-cleared status, and pharma CDx partnerships make it a benchmark competitor for Biodesix's IQLung franchise.
• Exact Sciences: Exact Sciences is a major cancer diagnostics company best known for Cologuard (colorectal cancer screening) and Oncotype DX (treatment guidance in breast cancer). It is a broad incumbent in cancer screening and treatment guidance that competes for payer mindshare and physician adoption across oncology.
• Quest Diagnostics: Quest Diagnostics is one of the largest clinical laboratory networks in the US, offering extensive oncology and pulmonology testing menus. It is a broad incumbent whose scale, payer contracts, and hospital relationships shape the competitive backdrop for Biodesix's specialty lung cancer testing franchise.
• Labcorp: Labcorp operates one of the largest clinical laboratory networks globally, providing oncology, genomic, and esoteric testing as well as clinical trial services through its drug development business. It is a broad incumbent competing in both clinical diagnostics and biopharma services, where Biodesix Development Services also operates.

Emerging players

• Oncocyte: Oncocyte develops proprietary blood-based diagnostic tests focused on lung cancer (DetermaRx, DetermaIO) and transplant rejection (GraftAssure). It is an emerging peer with a focused lung cancer product portfolio that directly overlaps with Biodesix's Nodify and IQLung product lines.
• Caris Life Sciences: Caris Life Sciences offers MI Profile and Caris Assure for molecular profiling and MRD detection in oncology using both tissue and blood-based approaches. It is an emerging direct competitor in comprehensive cancer molecular profiling with a similar biopharma services model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@biodesix
• LinkedInlinkedin.com/company/biodesix-inc-
• Xx.com/biodesixinc
• Facebookfacebook.com/biodesix

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds22 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biodesix