Biodesix Obtains Medicare Coverage for the Nodify CDT® Lung Nodule Test
07 Giugno 2022 - 12:00PM
Business Wire
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, announced that WPS
Government Health Administrators, the Medicare Administrative
Contractor with jurisdiction for Biodesix’s De Soto, Kansas
laboratory, has provided coverage for the Nodify CDT® lung nodule
test.
The Nodify CDT test is a part of the Biodesix’s blood-based
Nodify Lung® Nodule Risk Assessment testing strategy consisting of
two tests to aid physicians in stratifying patients into distinct
nodule management treatment pathways: diagnostic procedure or
imaging surveillance. The Nodify CDT test helps identify patients
with lung nodules that are likely malignant or higher risk of
cancer, and the Nodify XL2® test conversely helps identify those
that are likely benign or lower risk of cancer.
“Medicare coverage is a significant milestone for the Nodify CDT
test to ensure access and availability for patients with lung
nodules. Medicare coverage for both the Nodify CDT and Nodify XL2
tests leverages our capability to ensure physicians have access to
these insightful and valuable tests to help determine if a lung
nodule is likely malignant or likely benign and help guide to best
course of action for each individual patient,” said Robin Harper
Cowie, Chief Financial Officer, Biodesix. “This important coverage
and our increasing physician adoption of the Nodify CDT test
further demonstrates the clinical relevance of our nodule risk
assessment testing. Biodesix is strongly positioned to continue
driving adoption of Nodify Lung testing in 2022,” said Kieran
O’Kane, Chief Commercial Officer, Biodesix.
Now, all five Biodesix blood-based lung diagnostic tests within
the Nodify Lung Nodule Risk Assessment testing strategy and IQLung™
strategy for lung cancer patients are now covered by Medicare. 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 36-72 hours, expediting
time to treatment.
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® 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 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 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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version on businesswire.com: https://www.businesswire.com/news/home/20220607005381/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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