Biodesix Enhances Access to Nodify Lung® Testing with Launch of New Blood Draw Method
November 14 2023 - 6:00AM
Business Wire
Capillary device supports in-office blood
collection in diverse practice locations without the need for
venipuncture
Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions
company with a focus in lung disease, announced today the
validation and launch of a new method of collecting blood specimens
for Nodify Lung Nodule Risk Assessment testing. The method uses the
FDA-cleared Tasso+™ device, a single-use blood lancing device
intended for obtaining capillary whole blood samples from a
patient’s upper arm.
Blood-based Nodify Lung testing, comprised of the Nodify CDT®
and Nodify XL2® tests, addresses a significant unmet need by
assessing the risk of cancer in patients with lung nodules.
Biodesix offers a range of venous blood draw services, including an
extensive network of mobile phlebotomists and independent
laboratories. Capillary blood draws using the Tasso+ device enable
blood specimen collection for healthcare providers who do not have
convenient access to phlebotomy services or a licensed phlebotomist
on staff in the clinic or office. The Tasso+ device was validated
by Biodesix to be administered in minutes by any healthcare
provider at the time of lung nodule evaluation, creating
efficiencies in the Nodify Lung workflow.
“The capillary blood collection device has been extremely useful
to deliver high quality patient care,” said Pedro Del Pino, a
Thoracic and General Surgeon who works at Oneida Health and is
leading lung nodule management efforts in the Oneida area. “Oneida
Health is a referral center serving patients in a wide geographical
area. This device has allowed us to order Nodify Lung testing when
patients are here for visits, ensuring that we get the critical
information to inform the shared decision-making process quickly
and accelerate the time to diagnosis.”
Biodesix received approval from the New York State Clinical
Laboratory Evaluation Program (NYS-CLEP) to use the Tasso+ device
as a specimen collection method in support of Nodify Lung testing
after entering into a supply agreement with Tasso, Inc. The device
is now available for clinical use to collect specimens for Nodify
Lung testing.
“Improving patient access to diagnostic tests in all geographies
and practice settings is of the utmost importance,” said Kieran
O’Kane, Chief Commercial Officer of Biodesix. “We know that
physicians serve diverse patient populations, some of whom may have
to commute hours to access healthcare services. The Tasso+ device
provides a convenient option to collect blood specimens, ensuring
that the test results are available in a timely manner and
preventing patients from having to make a second trip to have their
blood drawn.”
Tasso+ is a trademark of Tasso, Inc.
About Biodesix
Biodesix is a leading 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 6, 2023 or subsequent quarterly reports on Form
10-Q during 2023, 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/20231114108534/en/
Media: Robbie Lunt robbie.lunt@biodesix.com
1-866-432-5930
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
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