COMPANY:

Biodesix

"Biodesix, Inc...announced that the company is designated as a Thermo Fisher Scientific Center of Excellence (COE) as part of Thermo Fisher’s collaborative initiative to advance NGS-based diagnostics. ..Upcoming presentations to learn more about the Thermo Fisher NGS precision oncology solution and how Biodesix will apply the science for its industry clients and healthcare professionals...August 27, 2025 | CAP TODAY | Thermo Fisher Scientific Webinar: Introduction of new FDA approved rapid NGS solution for Companion Diagnostics & tumor profiling in oncology...September 15, 2025 | Orlando, FL | College of American Pathologists (CAP) 2025 Annual Meeting | Thermo Fisher-sponsored Panel: "Introduction of new IVD solution for rapid NGS profiling in Oncology"

"Biodesix, Inc...announced that new data will be presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2025 Annual Meeting in Montreal, Quebec and at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, California.The presentation titled “Time to Diagnosis of Lung Cancer from Identification of a Pulmonary Nodule in the United States” was presented yesterday by Kimberly Le, Biodesix Director of Health Economics and Outcomes Research at ISPOR 2025."

"Biodesix...announced a new post-market clinical validation study was published in CHEST Pulmonary Journal that reaffirms the previously established performance of the Nodify CDT® blood-based lung nodule test...Analysis of 447 patients receiving the Nodify CDT blood-based lung nodule test published in CHEST Pulmonary Journal reaffirms test performance"

"Biodesix, Inc...announced that new data will be presented at the CHEST Annual Meeting 2024 in Boston, Massachusetts on Tuesday, October 8 at 10:20 am ET. The presentation will detail the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting....At the CHEST conference, 'Use of a blood-based biomarker for indeterminate nodules in community settings,' will be presented by Kathryn Long, MD of the Medical University of South Carolina. It will describe clinical use patterns and national reclassification rates consistent with prior studies, highlighting the high proportion of results that up- or down-classify patients into actionable risk categories with clear, guideline-recommended, diagnostic plans."

"Biodesix, Inc...announced that new data will be presented today at the 2024 American Thoracic Society (ATS) International Conference in San Diego, California. The presentation, titled 'Performance comparison of a blood-based integrated classifier for lung nodule risk stratification in patients with versus without emphysema,' will be presented by Arthur Romero MD, MSC, FCCP, Associate Professor of Pulmonary and Critical Care Medicine at the University of Nevada Las Vegas."

"Biodesix, Inc...today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. These presentations highlight advancements in liquid biopsy technologies that detect cell free DNA (cfDNA) and the clinical value of rapid turnaround time to detect actionable tumor mutations in a real-world clinical setting....An independent presentation of an exploratory analysis from the FLAURA2 clinical study, sponsored by AstraZeneca, was also presented as a plenary session....Results suggest that baseline detection of plasma EGFRm may identify a subgroup of patients who would derive most benefit from the addition of platinum-pemetrexed chemotherapy to osimertinib as first-line treatment for EGFR-mutated advanced NSCLC."

"Biodesix, Inc...announced that it has entered into a new master collaborative research agreement (MCRA) with Memorial Sloan Kettering Cancer Center (MSK) under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK."

"Biodesix, Inc...announced...the validation and launch of a new method of collecting blood specimens for Nodify Lung Nodule Risk Assessment testing. The method uses the FDA-cleared Tasso+™ device, a single-use blood lancing device intended for obtaining capillary whole blood samples from a patient’s upper arm."

"Biodesix, Inc...announced that new data will be presented at the CHEST Annual Meeting 2023 in Honolulu, Hawaiʻi. These presentations will provide new insight on the clinical utility and real-world impact of the Nodify CDT and Nodify XL2 tests in the comprehensive management of lung nodules....The presentation will delve into subgroup analyses from the prospective, real-world ORACLE study (NCT03766958), evaluating the clinical utility of the Nodify XL2 test across the spectrum of nodule types.... The presentation will demonstrate the complementary nature of the Nodify CDT test and PET/CT imaging results."

"Biodesix, Inc...announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC)....'It is crucial to be able to determine which 10-15% of early stage lung cancer patients will recur within 3-5 years after their tumor is completely removed by surgery, and we are encouraged that our model, especially when incorporating the IASLC Histologic Grading System, may lead to more accuracy in this regard,' said Harvey Pass, MD lead author of the abstract. 'Nevertheless, this work requires further external validation with other cohorts of Stage I lung cancer patients before it could be used clinically to determine who needs appropriate adjuvant therapy.'"

"Biodesix, Inc...announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC). The first presentation showcases a new analysis of the large multi-center observational registry study INSIGHT...demonstrating the ability of the VeriStrat host immune classifier to predict response to immune checkpoint inhibitor (ICI) regimens in patients with advanced stage non-small cell lung cancer (NSCLC)....The second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts."

P=Obs | N=842 | NCT03766958 | Sponsor: Biodesix, Inc. | "Biodesix, Inc...announced today that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP)....The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group."