Biodesix Announces Presentation of New Nodify XL2® Data at AABIP Conference Highlighting Increased Proportion of Biopsies Diagnosing Cancer
August 22 2023 - 6:00AM
Business Wire
Data demonstrates a 51% relative increase in the proportion of
lung nodule biopsies diagnosing cancer
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, announced today
that a new analysis from the post-market, prospective, real-world
ORACLE study (An Observational Registry Study to Evaluate the
Performance of the Nodify XL2 Test NCT03766958) will be presented
at the 6th Annual Conference of the American Association for
Bronchology and Interventional Pulmonology (AABIP). The data will
be presented by principal investigator of the ORACLE study, Michael
Pritchett, DO, MPH, on Thursday, Aug. 24, 2023 in a live poster
presentation in Chicago, IL.
The Nodify XL2 test is designed to identify likely benign lung
nodules that can be monitored with computed tomography (CT) scans
instead of costly invasive procedures. The primary endpoint of the
ORACLE study demonstrated that patients with benign lung nodules
managed with the test were 74% less likely to undergo an
unnecessary invasive procedure compared to the control group.
Additionally, the proportion of patients sent to CT surveillance
with malignant nodules did not differ between the Nodify XL2 group
and the control group.
The analysis to be presented at AABIP investigated the effect of
improved identification of benign lung nodules on the remaining
patients who received a diagnostic biopsy. Prior to implementation
of the Nodify XL2 test, 49% of patients receiving a biopsy had a
lung cancer diagnosis compared to 74% when the test was used in
clinical decision making, representing a 51% relative increase in
the cancer diagnosis rate.
“Finding a suspicious lung nodule can create fear and anxiety
for patients, whether it is found through lung cancer screening or
an incidental finding from imaging for general medical purposes,”
said Dr. Pritchett. “It is very encouraging that the Nodify XL2
test is helping physicians avoid unnecessary invasive procedures on
benign lung nodules and prioritize patients with a higher risk of
lung cancer. These results offer peace of mind to both patients and
providers as they navigate the diagnostic plan.”
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 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.
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, its 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 or subsequent quarterly reports on Form
10-Q during 2022, 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.
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Media: Robbie Lunt robbie.lunt@biodesix.com
1-866-432-5930
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
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