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Biodesix

From EverybodyWiki Bios & Wiki


Biodesix, Inc.[1] is a United States-based medical diagnostics company that develops and commercializes blood-based tests for lung disease.[2] The company was founded in 2006 and is headquartered in Louisville, Colorado. It is led by Chief Executive Officer Scott Hutton.[3][4][5]

History

Biodesix is a medical diagnostics company founded in 2006 in Boulder, Colorado, now headquartered in Louisville, Colorado.[6][7] The company started by developing blood-based tests that use proteomic and genomic technologies to support the evaluation and management of lung diseases like lung cancer.[1][8]  

In its early years, Biodesix applied mass spectrometry and molecular analysis techniques to identify biomarkers for disease classification.[9][10] One of its first commercially available tests was VeriStrat, a proteomic test used to provide prognostic information in patients with non-small cell lung cancer (NSCLC).[11][10][12] The company later introduced the GeneStrat test series, which started by using droplet digital PCR (ddPCR) and later expanded to include next-generation sequencing (NGS) for detecting actionable mutations in circulating tumor DNA.[13][14][15][16]  

Biodesix’s diagnostic offerings were further expanded with the addition of the Nodify Lung testing portfolio, which includes Nodify CDT and Nodify XL2.[17][18] These tests combine protein biomarker analysis with clinical and imaging data to evaluate the risk level associated with pulmonary nodules.[18][19] 

The company has participated in multiple clinical studies to assess the performance and clinical relevance of its tests, including the INSIGHT observational study and the randomized ALTITUDE trial. These studies were designed to evaluate diagnostic accuracy and impact on medical decision-making in both real-world and controlled research settings.[17][20][21]

Biodesix completed its initial public offering in October 2020 and is listed on the Nasdaq stock exchange under the ticker symbol BDSX.[22][23] The company maintains laboratory operations in Louisville, Colorado, and De Soto, Kansas, with approximately 300 employees.[24] The company’s laboratory facilities are certified under the Clinical Laboratory Improvement Amendments (CLIA) and approved by the New York State Clinical Laboratory Evaluation Program (CLEP).[25][26]

Biodesix has offered Development Services to life sciences and diagnostics companies, as well as biopharmaceutical companies since the company's inception. Their clients include Bio-Rad, Johnson & Johnson Pharma,Thermo Fisher Scientific, Bruker, AstraZeneca, Roche, Memorial Sloan Kettering Cancer Center, and others.[27][28][29][30][31][32]

Products/Tests

Biodesix operates laboratory facilities in Louisville, Colorado, and De Soto, Kansas.[6] Its diagnostic tests are used in clinical practice to assist physicians in lung cancer diagnosis, treatment planning, and disease monitoring.[33]

Nodify Lung Test - Nodule Risk Assessment

  • Nodify CDT test measures circulating autoantibodies associated with malignancy and is used to identify patients who may be at higher risk of lung cancer.[34][35][36]
  • Nodify XL2 test assesses peptide biomarkers alongside clinical and imaging data to estimate the likelihood that a nodule is benign. When ordered together, Nodify CDT is typically used first for preliminary risk assessment; if no elevated antibody levels are detected, Nodify XL2 is then performed. There are many published papers with clinical data to support the performance of these tests.[37][38][39]

IQ Lung Test - Cancer Treatment Guidance

  • Biodesix introduced its first proteomic diagnostic test, Veristrat, after its founding in 2006. The test provides prognostic information and supports therapy selection for patients with non-small cell lung cancer (NSCLC) through analysis of the immune response using proteomic profiling.[40][41][42] 
  • The company later launched GeneStrat, a blood-based tumor profiling test that identifies actionable genetic alterations in lung cancer using droplet digital PCR (ddPCR). Note: ddPCR is technology from Bio-Rad. An expanded version, GeneStrat NGS, was subsequently introduced to analyze a broader 52-gene panel. These tests are used in advanced-stage NSCLC to support therapeutic decision-making and have been integrated into clinical genomic profiling workflows.[43]

Biodesix has conducted many clinical studies to assess its testing solutions, with three active studies in 2025:

  • The ALTITUDE randomized controlled trial is designed to evaluate the clinical utility of Nodify XL2 in patients with incidentally detected pulmonary nodules.[44]
  • The CLARIFY study, a retrospective chart review, aims to analyze real-world use of both Nodify CDT and Nodify XL2 in up to 4,000 patients.[45]
  • The company also completed enrollment for the INSIGHT observational study, which involved 5,000 patients and examined the use of VeriStrat, GeneStrat ddPCR, and GeneStrat NGS in the management of NSCLC.[46]

External links

References

  1. ↑ 1.0 1.1 https://finance.yahoo.com/quote/BDSX/profile/
  2. ↑ https://www.sec.gov/ix?doc=/Archives/edgar/data/1439725/000095017025030835/bdsx-20241231.htm
  3. ↑ "How Scott Hutton Calls the Plays for Biodesix | The Healthcare Technology Report". 2025-05-29. Retrieved 2025-08-11.
  4. ↑ "For bioscientists facing funding cuts, tariffs: 'It's grim out there' – BizWest". 2025-04-25. Retrieved 2025-08-11.
  5. ↑ Brouk, Tim (2022-02-23). "Distinguished Alumnus: A career in HHS is an 'opportunity to give back, to help people'". News | College of Health and Human Sciences. Retrieved 2025-08-11.
  6. ↑ 6.0 6.1 "Colorado Hub for Health Impact". Retrieved 2025-08-01.
  7. ↑ The most innovative architecture companies for 2025 - Fast Company
  8. ↑ Writer, Inside Precision Medicine Staff (2018-07-09). "Biodesix Acquires Integrated Diagnostics, Expanding Lung Disease Franchise". Inside Precision Medicine. Retrieved 2025-08-01.
  9. ↑ Kuiper, J. L.; Lind, J. S. W.; Groen, H. J. M.; Roder, J.; Grigorieva, J.; Roder, H.; Dingemans, A. M. C.; Smit, E. F. (November 2012). "VeriStrat® has prognostic value in advanced stage NSCLC patients treated with erlotinib and sorafenib". British Journal of Cancer. 107 (11): 1820–1825. doi:10.1038/bjc.2012.470. ISSN 1532-1827. PMC 3505013. PMID 23079575.
  10. ↑ 10.0 10.1 Grossi, F.; Rijavec, E.; Genova, C.; Barletta, G.; Biello, F.; Maggioni, C.; Burrafato, G.; Sini, C.; Dal Bello, M. G.; Meyer, K.; Roder, J.; Roder, H.; Grigorieva, J. (January 2017). "Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy". British Journal of Cancer. 116 (1): 36–43. doi:10.1038/bjc.2016.387. ISSN 1532-1827. PMC 5220151. PMID 27898657.
  11. ↑ Writer, Inside Precision Medicine Staff (2018-08-29). "Study Confirms Prognostic Value of Biodesix VeriStrat Test in NSCLC Patients". Inside Precision Medicine. Retrieved 2025-08-01.
  12. ↑ Soo, Ross A.; Adjei, Alex A. (2017-04-01). "Predicting Clinical Outcomes Using Proteomics in Non–Small Cell Lung Cancer—The Past, Present, and Future". Journal of Thoracic Oncology. 12 (4): 602–606. doi:10.1016/j.jtho.2017.01.025. ISSN 1556-0864. PMID 28343541.
  13. ↑ "Select Science — Editorial Article: Digital PCR technology drives progress in early lung cancer diagnosis and personalized therapy". Friends of Cancer Research. 2023-10-17. Retrieved 2025-08-01.
  14. ↑ Biodesix. "Biodesix Presents Cell-free DNA Process Optimization for Liquid Biopsy Test". Lab Manager. Retrieved 2025-08-01.
  15. ↑ Bronkhorst, Abel J.; Holdenrieder, Stefan (December 2023). "The changing face of circulating tumor DNA (ctDNA) profiling: Factors that shape the landscape of methodologies, technologies, and commercialization". Medizinische Genetik: Mitteilungsblatt des Berufsverbandes Medizinische Genetik e.V. 35 (4): 201–235. doi:10.1515/medgen-2023-2065. ISSN 1863-5490. PMC 11006350 Check |pmc= value (help). PMID 38835739 Check |pmid= value (help).
  16. ↑ Koc, Matthew A.; Wiles, Timothy Aaron; Weinhold, Daniel C.; Rightmyer, Steven; Weaver, Amanda L.; McDowell, Colin T.; Roder, Joanna; Asmellash, Senait; Pestano, Gary A.; Roder, Heinrich; Georgantas III, Robert W. (2023-11-01). "Molecular and translational biology of the blood-based VeriStrat® proteomic test used in cancer immunotherapy treatment guidance". Journal of Mass Spectrometry and Advances in the Clinical Lab. 30: 51–60. doi:10.1016/j.jmsacl.2023.11.001. ISSN 2667-145X. PMC 10709509 Check |pmc= value (help). PMID 38074293 Check |pmid= value (help).
  17. ↑ 17.0 17.1 "10-K".
  18. ↑ 18.0 18.1 Pritchett, Michael A.; Sigal, Barry; Bowling, Mark R.; Kurman, Jonathan S.; Pitcher, Trevor; Springmeyer, Steven C.; ORACLE Study Investigators (2023). "Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study". PLOS ONE. 18 (7): e0287409. Bibcode:2023PLoSO..1887409P. doi:10.1371/journal.pone.0287409. ISSN 1932-6203. PMC 10335667 Check |pmc= value (help). PMID 37432960 Check |pmid= value (help).
  19. ↑ https://www.bcbsri.com/providers/sites/providers/files/policies/2024/08/2024%20Proteomic%20Testing%20for%20Targeted%20Therapy%20in%20Non-Small-Cell%20Lung%20Cancer.pdf
  20. ↑ Biodesix, Inc. (2024-02-06). An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer (Report). clinicaltrials.gov.
  21. ↑ Biodesix, Inc. (2025-07-21). A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules (Report). clinicaltrials.gov.
  22. ↑ renaissancecapital.com (2020-10-28). "Diagnostics provider Biodesix prices downsized $72 million IPO at $18 midpoint". Renaissance Capital. Retrieved 2025-08-04.
  23. ↑ "Boulder biotech Biodesix CEO: Why timing was right for IPO". www.bizjournals.com. Retrieved 2025-08-04.
  24. ↑ "Biodesix 2025 Company Profile: Stock Performance & Earnings | PitchBook". pitchbook.com. Retrieved 2025-08-11.
  25. ↑ "Biodesix Inc Laboratory". www.wadsworth.org. Retrieved 2025-08-04.
  26. ↑ "Biodesix Inc Laboratory". www.wadsworth.org. Retrieved 2025-08-04.
  27. ↑ Felip, E.; Cho, B. C.; Gutiérrez, V.; Alip, A.; Besse, B.; Lu, S.; Spira, A. I.; Girard, N.; Califano, R.; Gadgeel, S. M.; Yang, J. C.-H.; Yamamoto, S.; Azuma, K.; Kim, Y. J.; Lee, K.-H. (2024-09-01). "Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA". Annals of Oncology. 35 (9): 805–816. doi:10.1016/j.annonc.2024.05.541. ISSN 0923-7534. PMID 38942080 Check |pmid= value (help).
  28. ↑ "Bio-Rad Outlines Its Advances Leveraging Droplet Digital PCR in Biopharma and Translational Research Sectors | Bio-Rad". www.bio-rad.com. Retrieved 2025-08-11.
  29. ↑ "Oncomine Dx Express Test - US". www.thermofisher.com. Retrieved 2025-08-11.
  30. ↑ Philippidis, Alex (2019-07-09). "Biodesix Partners with Thermo Fisher on NGS Assay for Blood-Based NSCLC Diagnostic". Inside Precision Medicine. Retrieved 2025-08-11.
  31. ↑ Apr 12; Reporter, 2013 | Staff (2013-04-11). "Biodesix Inks Deal w/Bruker for Mass Spec Support; Closes on $8.8M Series D Financing". GenomeWeb. Retrieved 2025-08-11.
  32. ↑ Dec 16; Reporter, 2024 | Staff (2024-12-16). "AstraZeneca to Use Tracer Biotechnologies Cancer Monitoring Tech for Clinical Trials". 360Dx. Retrieved 2025-08-11.
  33. ↑ https://www.premera.com/medicalpolicies/2.04.515.pdf?
  34. ↑ https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam-assets/029%20Molecular%20Testing%20in%20the%20Management%20of%20Pulmonary%20Nodules%20prn.pdf?
  35. ↑ https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2095722.pdf?
  36. ↑ Long, Kathryn J.; Silvestri, Gerard A.; Kammer, Michael N.; Gibbs, Sarah; Wu, Wei; Johal, Monica; Pipavath, Sudhakar; Pitcher, Trevor; Jett, James; Nair, Viswam S. (2025-03-01). "Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules". Chest Pulmonary. 3 (1): 100130. doi:10.1016/j.chpulm.2024.100130. ISSN 2949-7892. PMC 12037156 Check |pmc= value (help). PMID 40296864 Check |pmid= value (help).
  37. ↑ https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2095722.pdf?
  38. ↑ https://www.excellusbcbs.com/documents/d/global/exc-prv-molecular-testing-in-the-management-of-pulmonary-nodules?
  39. ↑ https://www.keystonefirstpa.com/content/dam/keystone-first/keystone-first-pa/pdf/provider/resources/clinical/policies-202502/ccp1503-serum-proteomic-cancer-risk-classification-indeterminate-pulmonary-nodules.pdf.coredownload.inline.pdf?
  40. ↑ https://www.medrxiv.org/content/10.1101/2022.12.28.22283689v1.full.pdf?
  41. ↑ Grossi, Francesco; Genova, Carlo; Rijavec, Erika; Barletta, Giulia; Biello, Federica; Dal Bello, Maria Giovanna; Meyer, Krista; Roder, Joanna; Roder, Heinrich; Grigorieva, Julia (March 2018). "Prognostic role of the VeriStrat test in first line patients with non-small cell lung cancer treated with platinum-based chemotherapy". Lung Cancer (Amsterdam, Netherlands). 117: 64–69. doi:10.1016/j.lungcan.2017.12.007. ISSN 1872-8332. PMID 29395121.
  42. ↑ Carbone, David P.; Ding, Keyue; Roder, Heinrich; Grigorieva, Julia; Roder, Joanna; Tsao, Ming-Sound; Seymour, Lesley; Shepherd, Frances A. (2012-11-01). "Prognostic and Predictive Role of the VeriStrat Plasma Test in Patients with Advanced Non–Small-Cell Lung Cancer Treated with Erlotinib or Placebo in the NCIC Clinical Trials Group BR.21 Trial". Journal of Thoracic Oncology. 7 (11): 1653–1660. doi:10.1097/JTO.0b013e31826c1155. ISSN 1556-0864. PMID 23059783.
  43. ↑ "Liquid Biopsy AHS - G2054 | Providers | Blue Cross NC". www.bluecrossnc.com. Retrieved 2025-08-11.
  44. ↑ Biodesix, Inc. (2025-07-21). A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules (Report). clinicaltrials.gov.
  45. ↑ Biodesix, Inc. (2025-02-06). A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World (Report). clinicaltrials.gov.
  46. ↑ Biodesix, Inc. (2024-02-06). An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer (Report). clinicaltrials.gov.

References


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