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Biodesix Study Shows Proprietary Device Collects, Separates, and Transports Blood at Ambient Temperature

Findings Suggest Blood Collection Device Simplifies Specimen Collection and Transport While Maintaining Accuracy of Diagnostic Test Results

Boulder, CO, December 15, 2020 - Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, today announced publication of a peer-reviewed study supporting its patented blood collection device (BCD). The device is designed to streamline whole blood specimen collection and transportation to the laboratory while delivering diagnostic test results that are equivalent to traditional methods.

Published in Diagnostics, the paper titled, “Design and Characterization of a Novel Blood Collection and Transportation Device for Proteomic Applications,” presents findings that the BCD enables whole blood specimens to be collected with ease by healthcare personnel and shipped at ambient temperature to clinical laboratories for testing. These novel uses of the device serve to eliminate the need for blood processing by centrifugation at the collection sites, and remove the need for dry ice or other cold chain transport in shipping. In light of ongoing blood supply shortages and logistical challenges, Biodesix believes that the BCD could offer significant value for companies engaged in blood collection.
“The blood collection device has allowed us to create efficiencies in sample collection processes for two of our tests, and will support our future proteomic products. Considering the number of molecular tests that currently require complex logistics and transport processes, the BCD has the potential to support a wide array of clinical and research applications,” said Scott Hutton, CEO of Biodesix. “By utilizing this device, we expect to reduce healthcare costs associated with specimen transportation in addition to clinical development efforts, such as clinical trial administration costs.”

The BCD separates plasma from the cellular components of the whole blood sample. Once dried, the specimen can be transported under ambient conditions to laboratories for diagnostic as well as for research use.

The BCD has been studied using two blood-based proteomic techniques, matrix assisted laser desorption/ionization-time of flight (MALDI-ToF) and Multiple Reaction Monitoring (MRM). This study has demonstrated significant correlation between the BCD and sample collection that involves immediate centrifugation and dry ice shipment to the laboratory, suggesting that the BCD is a suitable alternative to standard collection methods.

“In addition to utilizing the BCD for our own proprietary proteomic tests, Biodesix is planning to make the device available for purchase by labs and diagnostic companies wishing to use this novel technology for their own sample processing, transportation, and testing,” said Gary Pestano, Ph.D., Chief Development Officer at Biodesix.

About Biodesix
Biodesix is a leading diagnostic 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 six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. 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. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix has patented the Blood Collection Device (U.S. Patent No. 10,422,729). 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. Moreover, Biodesix operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. 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.


Jordona Jackson Smith

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