Biodesix Awarded Advanced Diagnostic Laboratory Test Status for its Nodify CDT® Test by the Center for Medicare and Medicaid Services
06 7월 2023 - 10:11PM
Business Wire
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, today announced
that the Centers for Medicare & Medicaid Services (CMS) has
designated the Nodify CDT® Test as an Advanced Diagnostic
Laboratory Test (ADLT) effective June 30, 2023.
Obtaining ADLT status is a recognition that the Nodify CDT test
meets the stringent criteria established under the Protecting
Access to Medicare Act of 2014 (PAMA). ADLT status is reserved for
innovative tests with Medicare coverage that provide new clinical
diagnostic information that cannot be obtained from any other test
or combination of tests. The payment amount for the Nodify CDT test
as established by the Medicare Administrative Contractor is
$649.
"Receiving ADLT status is a major milestone for Biodesix and
confirms the clinical value and unique nature of the Nodify CDT
test," says Scott Hutton, President and CEO of Biodesix. "We are
committed to working closely with CMS and commercial payers to
ensure that patients and physicians have access to all tests in the
Biodesix portfolio that aid in the diagnosis and treatment of lung
cancer."
The Nodify CDT test is used in combination with the Nodify XL2®
test, previously awarded ADLT status on May 17, 2019, in Nodify
Lung® Nodule Risk Assessment Testing. These tests are designed to
help physicians assess the risk of malignancy of pulmonary nodules
to identify and prioritize high risk nodules for intervention while
avoiding unnecessary invasive procedures on benign nodules.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230706136084/en/
Media: Robbie Lunt robbie.lunt@biodesix.com
1-866-432-5930
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
Biodesix (NASDAQ:BDSX)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Biodesix (NASDAQ:BDSX)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024