Pipeline Test Identifies Patients Who Are Likely to Respond

New Positive Study Results Published in Clinical Cancer Research

BOULDER, CO, July 16, 2020 - Biodesix, Inc., a leader in lung cancer diagnostics, announced the publication of research findings on a diagnostic test capable of generating valuable data to help guide the treatment of patients with advanced non-small cell lung cancer (NSCLC). The paper, entitled “A serum protein classifier identifying patients with advanced non-small cell lung cancer who derive clinical benefit from treatment with immune checkpoint inhibitors,” concludes that a proteomic based diagnostic test can provide clinically significant information to predict outcomes of immune checkpoint inhibitor therapy and guide treatment choices made by physicians for patients with advanced NSCLC.

“Publication of this data is an important milestone for Biodesix, and the findings from this study are a direct reflection of our identity and purpose,” said Scott Hutton, CEO of Biodesix. “We are committed to advancing precision medical care to a level that reduces unnecessary treatment and health care costs, and that focuses on identifying and guiding the best treatment plan for every patient.”

“Publication of this data is an important milestone for Biodesix, and the findings from this study are a direct reflection of our identity and purpose,” said Scott Hutton, CEO of Biodesix. “We are committed to advancing precision medical care to a level that reduces unnecessary treatment and health care costs, and that focuses on identifying and guiding the best treatment plan for every patient.”

In the retrospective study, mass spectrometry-based proteomic analysis was performed on pretreatment sera derived from advanced NSCLC patients who were treated with nivolumab as part of routine clinical care. The 289 enrolled patients were stratified into three groups after receiving second-line treatment: good (sensitive), intermediate and poor (resistant). Pooled analysis demonstrated significantly better overall survival rates for "sensitive" relative to "resistant" patients treated with nivolumab. A signature consisting of 274 mass spectrometry features was associated with progression-free survival and overall survival across two validation groups. The study demonstrated that this serum-derived proteomic signature successfully stratified outcomes in groups of advanced NSCLC patients treated with second line PD-1 checkpoint inhibitors.

The paper was authored by Mirte Muller, Karlijn Hummelink, Daan P. Hurkmans, Anna-Larissa N. Niemeijer, Kim Monkhorst, Joanna Roder, Carlos Oliveira, Heinrich Roder, Joachim G. Aerts and Egbert F Smit and published online in Clinical Cancer Research on July 6, 2020.

About
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™ test and the Nodify CDT™ test 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. For more information about Biodesix, please visit www.biodesix.com.

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