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Biodesix Strengthens Lung Nodule Testing Strategy with the Nodify CDT™ Test

Test Further Defines Risk of Malignancy with a Single Blood Draw

BOULDER, CO, March 3, 2020 - Biodesix, Inc. a leader in lung cancer diagnostics, is extending its blood-based testing portfolio with the release of the Nodify CDT test, designed to help physicians identify patients with lung nodules at high risk of lung cancer.

This launch supplements the Company’s Nodify XL2™ test, which is designed to help identify lung nodules with a very low risk of cancer. Both tests will be offered together as the Nodify Lung™ Nodule Risk Assessment strategy, giving physicians the ability to order both tests from a single blood draw.

“We are grateful for Biodesix’s leadership in developing tests that help patients to know, without subjecting them to unnecessary procedures and losing precious time, what their risk level is for lung cancer,” commented Bonnie Addario, Co-Founder and Board Chair for the Go2 Foundation for Lung Cancer. “This reduces much of the uncertainty that plagues patients from the time a nodule is discovered until a care plan is determined.”

Nodify CDT testing works by harnessing the sophisticated disease detecting capabilities of the patient’s own immune system. The test detects circulating antibody proteins that are generated by the patient’s immune system in the presence of lung cancer. Results will typically be available within a day of blood arriving at Biodesix’s lab in De Soto, KS. 

“With a single blood draw, we can help physicians identify people who are either more or less likely to have lung cancer. Given the short turnaround time of these tests, we can help physicians move patients quickly from lung nodule discovery to a definitive care plan.” said Scott Hutton, Biodesix CEO.

“Between the Nodify CDT and Nodify XL2 tests, we have an opportunity to redefine risk assessment for patients with suspicious lung nodules. With a single blood draw, we can help physicians identify people who are either more or less likely to have lung cancer. Given the short turnaround time of these tests, we can help physicians move patients quickly from lung nodule discovery to a definitive care plan.” said Scott Hutton, Biodesix CEO. “1.6 million Americans are diagnosed with incidental lung nodules each year; the problem physicians face is that it’s often difficult to determine whether a nodule is cancer or not without the patient undergoing an invasive procedure to get a tissue sample for further testing. These procedures are costly and carry a risk of complications even though many times the nodule is harmless. The alternative is to enter a watchful waiting period where a patient comes in every 3-6 months for follow up scans to see if the nodule grows or changes in a way that indicates it may be cancer. This waiting can cause a stress for the patient and their families. Physicians need better tools to assess the risk of cancer and inform which path to take. Launching the Nodify Lung strategy represents an important step for Biodesix and is driven by our vision of equipping physicians with reliable, actionable data so they can recommend with confidence the right pathway for every patient.”

About Biodesix

Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics through the power of artificial intelligence. Biodesix is the first company to offer four best-in class non-invasive tests for patients with lung cancer or suspicious lung nodules.

The 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 Nodify XL2™ test and the Nodify CDT TM test evaluate the risk of malignancy in incidental pulmonary nodules, enabling physicians to triage patients to the most appropriate course of action. The company’s strong product pipeline addresses key clinical questions in all stages of lung cancer, from risk assessment of early stage disease to informing treatment decisions for emerging therapies. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.

About GO2 Foundation for Lung Cancer
Founded by patients and survivors, GO2 Foundation for Lung Cancer (formerly the Bonnie J. Addario Lung Cancer Foundation and Lung Cancer Alliance), transforms survivorship as the world's leading organization dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. We work to change the reality of living with lung cancer by ending stigma, increasing public and private research funding, and ensuring access to care.

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 for Biodesix
(805) 674-7347

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