Biodesix Completes Enrollment of INSIGHT Study Assessing Clinical Utility of the VeriStrat® Blood-Based Host Immune Classifier
27 6월 2023 - 7:00PM
Business Wire
5,000 patients with non-small cell lung cancer enrolled to be
monitored up to three years
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, announced today
that the large multi-center observational registry study INSIGHT
(Clinical Effectiveness Assessment of VeriStrat® Testing and
Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780)
has completed enrollment of 5,000 patients with non-small cell lung
cancer (NSCLC). The study was designed to further validate the
utility of the VeriStrat® test, a novel predictive and prognostic
blood-based host immune classifier, and its ability to support
treatment decisions for patients with NSCLC across different
therapeutic approaches.
“The INSIGHT study gives us a unique opportunity to examine real
world treatment patterns for lung cancer, the deadliest of all
cancers, in the context of patients’ immune response,” said Dr.
James Jett, co-Chief Medical Officer at Biodesix. “Five-year
survival for patients with non-small cell lung cancer is
approximately 25 percent, but now we are seeing that with use of
this proteomic test, we are able to identify treatment options,
particularly those utilizing Immune Checkpoint Inhibitors in
addition to standard chemotherapy, that may extend overall survival
in select groups of patients.”
Results from prior analyses of the INSIGHT study demonstrated
that the VeriStrat test stratifies immune checkpoint inhibition
(ICI) treatment response in patients with advanced NSCLC. This data
demonstrated that those classified as Host Immune Classifier Cold
(HIC-C), also known as VeriStrat Poor, had superior median overall
survival when receiving ICI plus chemotherapy versus ICI alone,
independent of PD-L1 status.
A recent analysis from this study has been accepted for
presentation at the International Association for the Study of Lung
Cancer (IASLC) World Conference on Lung Cancer in Singapore in
September 2023. Future analyses of the INSIGHT study are planned in
2024, as monitoring of patient outcomes continues.
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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