Biodesix Announces New Data Presentation at CHEST 2024 Annual Meeting and the Launch of a Complementary Clinical Study
2024年10月7日 - 7:00PM
ビジネスワイヤ(英語)
Analysis of 35,000 patients tested with Nodify
Lung® Nodule Risk Assessment in a real-world setting to be
presented at CHEST 2024 and launch of a new clinical study designed
to expand data package
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 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.
Guidelines recommend that clinicians assess the risk of lung
cancer in patients with new nodules to inform the next steps for
the patient. Up to 80% of patients are assigned a low to moderate
risk, or a 5-65% risk of lung cancer, where next steps are unclear.
Biodesix Nodify Lung testing, comprised of the Nodify CDT® and
Nodify XL2® blood-based lung nodule tests, is designed to
reclassify the risk of lung cancer to a high (>65% risk) or very
low (<5% risk) category to better clarify the optimal next
steps.
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.
The company also announced a new clinical study, CLARIFY, that
will collect patient outcomes and other clinical information on a
subset of the patients featured in the CHEST presentation by Dr.
Long. CLARIFY is designed to confirm performance of the Nodify CDT
and Nodify XL2 tests in diverse patient subgroups through a
retrospective chart review of up to 4,000 patients that were tested
in a real-world clinical setting. The study’s intent is to expand
the extensive evidence characterizing the validation and utility of
Nodify Lung testing.
“Nodify Lung testing has changed the standard of care for
characterizing risk of malignancy in lung nodules over the past
four years and we are thrilled to share the aggregate experience of
healthcare providers using Nodify Lung testing in clinical
practice,” said Scott Hutton, Chief Executive Officer of Biodesix.
"CLARIFY represents the opportunity to supplement this dataset with
further clinical outcomes analysis and increase healthcare
providers’ confidence in clinical decision-making across distinct
patient populations, in various practice settings."
In addition, on Wednesday, October 9 at 10:30 am ET, Sonali
Sethi, MD, FCCP, Cleveland Clinic and D. Kyle Hogarth, MD, FCCP,
University of Chicago will discuss the "Patient impact and case
studies: the real-world value of biomarkers in lung nodule
management" at Learning Theater 4. This presentation will
review Nodify Lung case studies and the impact that the results
have on the patient experience and shared decision-making.
About Biodesix
Biodesix is a leading diagnostic solutions company with five
Medicare-covered tests available for patients with lung diseases.
The blood-based Nodify Lung® Nodule Risk Assessment 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™ test portfolio 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 and expedite personalized treatment. In
addition, Biodesix collaborates with the world’s leading
biopharmaceutical companies to provide biomarker discovery,
diagnostic test development, and clinical trial support services.
For more information, visit biodesix.com.
Note: The Biodesix logo, Biodesix, Nodify Lung, IQLung,
GeneStrat, GeneStrat NGS, VeriStrat, Nodify XL2 and Nodify CDT are
trademarks or registered trademarks of Biodesix, Inc. ddPCR is a
trademark of Bio-Rad Laboratories, Inc.
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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241004480817/en/
Media: Natalie St. Denis
Natalie.StDenis@biodesix.com 1-720-925-9285
Investors: Chris Brinzey
chris.brinzey@westwicke.com 1-339-970-2843
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