Biodesix to Present Data at the CHEST 2022 Annual Meeting Demonstrating High Sensitivity of the Nodify XL2® Blood-Based Lung Nodule Test in Various Patient Populations, Including Individuals Participating in Lung Cancer Screening Programs
12 Ottobre 2022 - 12:00PM
Business Wire
New data reinforces the performance of the
Nodify XL2® proteomic test in assessing risk of malignancy of
pulmonary nodules in different patient populations
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, announced today
that three data presentations will occur at the CHEST 2022 Annual
Meeting which will be held live and in-person for the first time
since 2019. Presentations will include a sub-group analysis of data
from the post-market, prospective, real-world ORACLE study (An
Observational Registry Study to Evaluate the Performance of the
Nodify XL2® Test - ORACLE [NCT03766958]) demonstrating that the
Nodify XL2 test has equivalent performance in identifying patients
with benign nodules discovered through lung cancer screening
programs, compared to those discovered incidentally through medical
imaging for unrelated diagnostic purposes. This prospectively
collected data reinforces the potential of the Nodify XL2 test to
identify high-risk individuals participating in lung cancer
screening who have a likely-benign lung nodule and can avoid an
unnecessary invasive biopsy.
“Last year, the United States Preventative Services Task Force
(USPSTF) expanded the screening criteria, doubling the population
eligible for low-dose computed tomography (LDCT) screening in the
U.S. to an estimated 16 million people” said James Jett, MD,
Co-Chief Medical Officer at Biodesix. “One out of four LDCT scans
reveal a new lung nodule, most of which are benign. Determining
which patients require a prompt biopsy and which can be monitored
with routine surveillance is critical to the goal of optimal
management of indeterminate pulmonary nodules.”
The ORACLE Study Principal Investigator, Michael Pritchett, DO,
MPH, Director, Chest Center of the Carolinas at FirstHealth and
past President of the Society for Advanced Bronchoscopy, released
this data based on the use of the Nodify XL2 test in a real-world
clinical practice setting.
“As expected, the data shows that we can use biological
information from patients’ blood as a complement to standard risk
assessment methods to better stratify patients with lung nodules,
possibly avoid invasive procedures on those that have benign
nodules and focus on the patients who may benefit from
interventions,” said Dr. Pritchett.
Rapid Fire Oral Presentation, Monday, October 17, 1:30 PM,
Exhibit Hall Rapid Area 4C: Comparison of the Performance of
a Blood-Based Integrated Classifier in Risk Stratifying Incidental
and Screening-Detected Pulmonary Nodules.
Dr. Pritchett will present a sub-group analysis from the ORACLE
study, which is evaluating healthcare providers utilizing the
blood-based Nodify XL2® proteomic test to reduce the number of
invasive procedures on benign lung nodules. The author reviewed the
test’s ability to identify benign lung nodules from patients (n =
280) who had a newly identified, 8-30 mm lung nodule discovered
incidentally (n = 211) or through a lung cancer screening program
(n = 69). The results demonstrate that the Nodify XL2 test did not
differ between the two populations, maintaining a high sensitivity
and negative predictive value (NPV) as previously reported in the
PANOPTIC clinical study (NCT01752114).
Oral Presentation, Monday, October 17, 1:30 PM, Convention
Center Room 104DE: Impact of the Nodify® Biomarker Panel for
Risk Stratification of Pulmonary Nodules at an Academic Medical
Center.
Jonathan Kurman, MD, MBA, FCCP, Director of Interventional
Pulmonology at the Medical College of Wisconsin and ORACLE study
investigator, reviewed 110 patients with 8-30 mm lung nodules
receiving Nodify Lung® testing in his clinical practice to assess
the reclassification rates from intermediate (5-65% probability of
cancer [pCA]) into high (>65% pCA) or very low (<5% pCA)
groups. In the oral presentation, Bailey Ray, MD from the Medical
College of Wisconsin will present the results of this analysis
demonstrating that approximately one-third of all patients were
reclassified into the high or very low risk group, further
informing diagnostic decisions through shared decision-making
discussions with patients.
Rapid Fire Oral Presentation, Wednesday, October 19, 11:15
AM, Exhibit Hall Rapid Area 3A: Impact of a Blood-Based
Integrated Classifier to Reclassify Lung Nodule Risk Across Nodule
Size Spectrum.
Dr. Kurman will present a sub-group analysis from the ORACLE
study assessing the performance of the Nodify XL2 proteomic test in
identifying benign lung nodules across nodule size groups: <10
mm (n = 92), 10-15 mm (n = 124), and >15 mm (n = 64). The
results demonstrate that the performance of the test is similar
across size groups with high sensitivity and NPV as previously
reported in the PANOPTIC clinical study (NCT01752114), identifying
patients who may benefit from CT surveillance independent of nodule
size.
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
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 average of 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. 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 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: Kieran O’Kane kieran.okane@biodesix.com (206)
548-6159 Investors: Chris Brinzey
chris.brinzey@westwicke.com (339) 970-2843
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