Biodesix to Present New Data on the Nodify XL2® Test at ATS 2024 Annual Meeting
Biodesix announced that it will present new data on the Nodify XL2 test at the 2024 ATS International Conference. The data focuses on the test's ability to identify benign lung nodules in patients with emphysema. The presentation will review a subgroup analysis from the ORACLE study involving 280 patients, demonstrating high negative predictive value of the test, helping to rule out lung cancer irrespective of emphysema status. Dr. Arthur Romero from UNLV will present the findings, suggesting that the test can help avoid unnecessary procedures, thereby allowing timely emphysema treatments.
- New data on Nodify XL2 test showcases high negative predictive value in detecting benign lung nodules.
- The Nodify XL2 test can potentially rule out lung cancer in patients with and without emphysema.
- Using the Nodify XL2 test may prevent unnecessary diagnostic procedures.
- The test may allow timely treatment of emphysema by confirming nodule benignity earlier.
- Presentation at ATS 2024 increases visibility and credibility of the Nodify XL2 test.
- The findings are based on a subgroup analysis of only 280 patients, which may limit generalizability.
- The efficacy of the Nodify XL2 test in real-world clinical settings outside the ORACLE study remains unproven.
- Potential over-reliance on the Nodify XL2 test could delay necessary interventions for malignant nodules.
Data highlights ability of the Nodify XL2 test to identify benign nodules in patients with emphysema
Emphysema is a common comorbid pulmonary condition in patients with lung nodules and presents unique diagnostic and treatment challenges. The presentation will review a subgroup analysis of 280 patients enrolled in the prospective, real-world ORACLE study (NCT03766958), demonstrating that the Nodify XL2 test has high negative predictive value, or true negative rate, in patients with and without emphysema. These results suggest that the test can assist with ruling out lung cancer regardless of a patient’s emphysema status.
"During the course of emphysema treatment, many of our patients present with suspicious lung nodules," said Dr. Romero. “Until we are confident that the lung nodule is benign, we cannot proceed with certain emphysema treatments capable of improving quality of life. Some nodules need to be followed for up to two years to establish stability, but many patients cannot wait this long. Using the Nodify XL2 test in these patients may help us avoid unnecessary diagnostic procedures and delays, allowing us to safely proceed with needed emphysema treatments.”
Details on the presentation are below:
Presentation Title: Performance comparison of a blood-based integrated classifier for lung nodule risk stratification in patients with versus without emphysema
Session Date and Time: Tuesday, May 21, 2024, 2:15 pm PT
Location: Room 29 A-D
Presenter: Arthur Romero, MD, MSC, FCCP
About Biodesix
Biodesix is a leading diagnostic solutions and services 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 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® 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 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.
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 backlog and the timing and assumptions regarding collection of revenues on projections, availability of funds and future capital including under the term loan facility, expectations regarding revenue and margin growth and its impact on profitability, and the impact of a pandemic, epidemic, or outbreak, including the COVID-19 pandemic, on Biodesix and its operations and financial performance. 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 most recent annual report on Form 10-K, filed March 1, 2024 or subsequent quarterly reports on Form 10-Q during 2024, if applicable. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240521548070/en/
Media:
Natalie St. Denis
natalie.stdenis@biodesix.com
(720) 925-9285
Investors:
Chris Brinzey
chris.brinzey@westwicke.com
(339) 970-2843
Source: Biodesix, Inc.
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