Biodesix Announces New Clinical Utility Evidence for the Nodify XL2® Nodule Risk Assessment Test to be Presented at ATS 2022 International Conference

Biodesix Announces New Clinical Utility Evidence for the Nodify XL2® Nodule Risk Assessment Test to be Presented at ATS 2022 International Conference




Biodesix Announces New Clinical Utility Evidence for the Nodify XL2® Nodule Risk Assessment Test to be Presented at ATS 2022 International Conference

BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announces new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference. The meeting will take place May 13-18, 2022, in San Francisco, California.

Data from the abstract titled, The Impact of Plasma Proteomics Biomarker on Clinical Management Decision in Lung Nodules, presented by Dr. J. P. Uribe of Deaconess Medical Center, Boston, Massachusetts, United States, will highlight data that show the impact of the Nodify XL2 integrated proteomic classifier on management decisions in a “real world” clinical setting. Conclusions show that when used in patients with lung nodules with a nodule probability of malignancy (pCA) of ≤ 50%, the blood-based lung nodule risk assessment test was able to support a decrease in chest imaging, outpatient clinic visits and additional invasive procedures without misclassifying benign lung nodules.

An additional presentation titled, ALTITUDE trial design: 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, will review the ALTITUDE study, a first-in-class biomarker study which aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer. The abstract, authored by Michael N. Kammer, Ph.D. of Vanderbilt University Medical Center, Nashville, Tennessee, Steve Springmeyer, MD, Biodesix, Boulder, Colorado and Gerard Silvestri, MD of Medical University of South Carolina, Charleston, South Carolina will be presented at ATS by Dr. Michael Kammer.

Both poster presentations will occur during ATS discussion Session B30 – THE QUEST FOR THE HOLY GRAIL: MODELING AND BIOMARKERS FOR NODULES AND LUNG CANCER. The session, moderated by Edwin Ostrin, MD, PhD. from MD Anderson Cancer Center, Houston, Texas and Adam Fox, MD, from Medical University of South Carolina, Charleston, South Carolina, will occur at the ATS meeting on May 16th, 2022, from 9:30-11:00AM PT, Room 203-204 (South Building, Level 2), Moscone Center.

About Biodesix

Biodesix is a leading data-driven 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 is the first company to offer eight non-invasive 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 incidental 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® ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting 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. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. For more information about Biodesix, visit biodesix.com.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, it is possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company’s ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 14, 2022. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contacts

Media:

Bobbi Coffin

bobbi.coffin@biodesix.com
(303) 892-3203

Investors:

Chris Brinzey

chris.brinzey@westwicke.com
(339) 970-2843