Biodesix Announces Data from Three Studies on Lung Nodule Diagnosis

Research Evaluates Risk Classification for Patients with Lung Nodules

Boulder, CO, October 20, 2020 - Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, recently published data from three clinical studies, which found important new information on diagnosis and management of lung nodules. Data from these studies, which are being presented at the American College of Chest Physicians (CHEST) annual meeting, demonstrate the value of the Nodify Lung™ testing strategy and confirm previously reported performance of the Nodify XL2® and Nodify CDT™ tests.

Abstract #A1464/Poster #P1319: Identification of Likely Malignant Indeterminate Pulmonary Nodules by Analysis of Autoantibodies Against Lung Cancer-Associated Antigens
Authors: Kevin Doubleday, James Jett, Laura Peek, Trevor Pitcher
A retrospective analysis of the PANOPTIC study found that the blood-based Nodify CDT test accurately identified patients whose lung nodules were likely malignant, which confirms previously reported test performance. Patients identified as Nodify CDT positive may benefit from a more rapid evaluation and intervention for cancer.

Abstract #A1468/Poster #P1325: Lung Nodule Integrated Classifier Biomarker: First Data with Real-World Clinical Use
Authors: James Jett, Kerstin Pohl, Gerard Silvestri, Steven Springmeyer
A real-world clinical use study demonstrates the utility of the blood-based Nodify XL2 test for identifying patients with likely benign lung nodules by integrating the patients’ blood-based protein data with clinical risk factors, resulting in a large proportion of low to moderate risk nodules being reclassified as very low risk. Risk reclassification can reduce invasive procedures on benign nodules and ultimately lead to improved nodule management.

Abstract #A1476/Poster #P1324: Use of Two Blood-Based Biomarker Tests in Series to Reclassify Risk of Indeterminate Pulmonary Nodules Authors: Kevin Doubleday, James Jett, Laura Peek, Trevor Pitcher, Steven Springmeyer
Data suggest that while standard risk assessment for lung cancer is imprecise, it can be improved with the blood-based Nodify Lung testing strategy. By combining the Nodify CDT and Nodify XL2 tests, patients can be more appropriately assessed for risk of malignancy to help reduce unnecessary procedures on patients with benign nodules and delays in treatment for patients with cancer.

About Biodesix
Biodesix is a leading diagnostic 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 is the first company to offer six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. 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 incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates 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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