Biodesix Announces Impactful Clinical Data on the Primary Immune Response (PIR) Test at the IASLC 2022 Therapies of Lung Cancer Meeting
03 3월 2022 - 8:00PM
Business Wire
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, today announced
impactful data on the Primary Immune Response (PIR) test at the
IASLC 2022 Targeted Therapies of Lung Cancer Meeting. In this body
of work, the PIR test provided two classifications of PIR-Not
Resistant and PIR-Resistant predictive of likely response to immune
checkpoint inhibitors (ICIs). The data showed that the Biodesix PIR
test was predictive for survival outcomes when tested at baseline
(HR=2.36, p=0.02) or 3 weeks after ICI treatment initiation
(HR=3.53, p=0.001). Furthermore, the data suggested that patients
classified as PIR-Resistant were more likely to experience rapid
onset of immune related adverse events (irAE) when treated with
ICIs (HR=2.40, p=0.08).
The PIR test is a serum-based proteomic assay that utilizes mass
spectrometry and machine learning. The study, titled Serum Proteomics Analysis as a Potential Predictive
Biomarker for Survival Outcomes and Immune-related Adverse Events
in Non-Small Cell Lung Cancer Receiving Immune Checkpoint
Inhibitors was authored by Leeseul Kim, MD of AMITA Health
Saint Francis Hospital, Evanston, Illinois, Myungwoo Nam, MD from
Lincoln Medical and Mental Health Center, Bronx, New York, and
Dong-Uk Lee, MD and Young Kwang Chae, MD, MPH, MBA, both from
Northwestern University Feinberg School of Medicine, Chicago IL.
The PIR test was validated on samples from patients receiving
second-line nivolumab and was shown to stratify patients based on
their outcomes to immunotherapy.
“This data is meaningful for patients with non-small cell lung
cancer who are being considered for treatment with ICIs. Immune
Checkpoint inhibitor drugs have gained interest in oncology because
of their ability to boost a person’s immune response against cancer
cells. It was recently estimated that nearly half of US patients
with cancer are eligible for ICI therapy, however only about 1 in 8
will respond,” said Scott Hutton, CEO, Biodesix. “Developing tools
that provide a better understanding of a patient’s likely overall
outcome and adverse events prior to treatment with ICIs will be
critical for both the physician and patient, which is the true
benefit of the PIR test.”
While the PIR test is not yet commercially available, it is
being studied further in multiple ongoing clinical studies and is
expected to launch commercially in 2023.
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 is the first
company to offer eight non-invasive 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 test, the
GeneStrat NGS™ test and the VeriStrat® test to support treatment
decisions across all stages of lung cancer with results in an
unprecedented 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. Biodesix launched
the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and
the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™
Neutralization Test Kit, GenScript, Inc,) in response to the global
pandemic and virus that impacts the lung and causes COVID-19. 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 16, 2021, or subsequent quarterly reports on Form
10-Q during 2021, 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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version on businesswire.com: https://www.businesswire.com/news/home/20220303005302/en/
Media: Bobbi Coffin bobbi.coffin@biodesix.com (303) 892-3203
Investors: Chris Brinzey chris.brinzey@westwicke.com (339)
970-2843
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