Studies highlight the clinical utility and real-world impact of the Nodify CDT® and Nodify XL2® tests in managing both benign and malignant pulmonary nodules.

Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today 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 first abstract, titled "Real-World Impact of a Blood-Based Integrated Classifier on the Management of Benign Solid, Part-Solid, and Ground Glass Pulmonary Nodules," will be presented by Jonathan Kurman, MD, Director of Interventional Pulmonology at the Medical College of Wisconsin, on Tuesday, October 10 at 12:00 pm HT (6:00 pm ET). 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 recently published primary endpoint of the study highlighted a 74% reduction in invasive procedures on benign nodules with use of the test. The analysis will demonstrate that this reduction is consistent across solid, part-solid, and ground glass lung nodules.

Dr. Kurman, remarked, "The data we're presenting at CHEST 2023 underscores the transformative potential of the Nodify XL2 test in managing all types of lung nodules. Clinical guidelines recommend different management strategies for solid versus non-solid nodules and this data indicates the test can be used broadly to avoid unnecessary invasive procedures."

The second abstract, titled "Comparison of a High Specificity Blood-Based Biomarker with PET/CT for Identifying Malignant Pulmonary Nodules," will be presented by Kathryn Long, MD, Pulmonary and Critical Care Fellow at the Medical University of South Carolina, on Wednesday, October 11 at 12:00 pm HT (6:00 pm ET). The presentation will demonstrate the complementary nature of the Nodify CDT test and PET/CT imaging results. PET/CT is a common imaging technique that detects abnormal levels of cellular metabolism and is clinically valuable in detecting cancer that has spread throughout the body. However, published data shows that the performance of PET/CT imaging alone is compromised in assessing small lung nodules for cancer. The analysis will demonstrate that the Nodify CDT test alongside PET/CT improves the performance, identifying malignant nodules with a high level of accuracy.

Additionally, independent studies by external investigators are expected at the event. "Novel Lung Cancer Biomarker Proteomic Testing on Lung Nodule Risk Stratification and Clinical Implications at a New York City Safety Net Hospital," is set to be presented in a rapid-fire format by Dr. Sonu Sahni, MD on Monday, October 9 at 12:00 pm HT (6:00 pm ET). Independent studies underscore the growing utility and adoption of Nodify Lung testing in the pulmonology community.

On Tuesday, October 10 at 1:00 pm HT (7:00 pm ET), Michael Pritchett, DO, and Jonathan Kurman, MD, will discuss the "Reduction of Diagnostic Interventions on Benign Lung Nodules: Results from the Nodify XL2® Clinical Utility Study" at Learning Theater 4. This presentation will highlight the ORACLE study's findings, covering primary and exploratory endpoints as well as multiple subgroup analyses from the study that have been published to date.

About Biodesix

Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung^® nodule risk assessment testing strategy, consisting of the Nodify XL2^® and the Nodify CDT^® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat^® targeted ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex^® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

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