Findings to be Presented at AACR Annual Meeting Further Demonstrate the Utility of Protein Biomarker Data to Support Physicians in Patient Management

BOULDER, Colo.–(BUSINESS WIRE)–#patientsfirstBiodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that three abstracts from multiple clinical studies will be showcased at the 2021 American Association for Cancer Research (AACR) Annual Meeting being held virtually April 10-15, 2021 and May 17-21, 2021. Findings from these studies address the utility of physicians using blood-based proteomic testing as an approach to interpret each patient’s immune response to cancer, which can help guide treatment decisions.

Abstract #520: Potential role of serum proteome in predicting immune-related adverse events from immunotherapy in non-small cell lung cancer

An abstract authored by Young Kwang Chae, MD, MPH, MBA of Northwestern University Feinberg School of Medicine, with lead author Dr. Myungwood Nam, reports data from a study on the Primary Immune Response (PIR) test. PIR is a serum-based proteomic classifier that, in this case, was used to study the correlation between immunotherapy and the development of immune-related adverse events (irAEs) in patients with non-small cell lung cancer (NSCLC). Following a baseline PIR test, patients were categorized as sensitive or not sensitive to immunotherapy treatment, then monitored for irAEs after the start of immunotherapy. The study found that patients who had been categorized as sensitive were more likely to tolerate immunotherapy without developing irAEs. The abstract concludes that the PIR test may be able to predict the development of irAEs, and identify patients who should be monitored more closely during treatment with immunotherapy. The data will be available for viewing at 4:30 p.m. ET on April 10 and poster sessions will be available at 8:30 a.m. ET on April 10.

Abstract #673: The role of mass spectrometry-based serum proteomics signatures in predicting clinical outcomes in cancer patients treated with immune check point inhibitors (ICI)

A second abstract, also authored by Dr. Chae, presents an analysis of a recent study using PIR to predict patient responses to ICI therapy. The study found the PIR test was able to reliably stratify patients into groups based on their expected prognosis. This information can be used by physicians to help guide their frontline ICI treatment decisions for patients with NSCLC who are identified as not sensitive to immunotherapy treatment and may benefit from more aggressive treatment. This data will become available at 4:30 p.m. ET on April 10 and poster sessions will be available at 8:30 a.m. ET on April 10.

Abstract #662: Longitudinal blood-based proteomic testing in advanced non-small cell lung cancer

An abstract authored by Eric Schaefer, MD, of Highlands Oncology Group, demonstrates that the VeriStrat® blood-based immune profiling test is capable of monitoring changes in disease state and patient immune response for patients with advanced NSCLC. The INSIGHT observational study (NCT03289780) found that the VeriStrat test was able to group patients according to their disease state and then monitor changes in disease state in response to treatment at 6- and 12-month follow-ups. This result suggests that longitudinal immune profile testing may be a viable option in monitoring such changes, and that the resulting data can be used to help guide treatment strategy. The data will become available for viewing at 4:30 p.m. ET on April 10.

“Our aim is to help patients access the most targeted treatment possible by providing physicians with timely, actionable data, that will assist their treatment decisions,” said Scott Hutton, CEO of Biodesix. “By continuing to invest in and increase our understanding of patient immune response, we can equip physicians with critical information to help them determine the best treatment strategy for patients with NSCLC.”

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. 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. 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 10K, filed March 16, 2021. 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.

Contacts

Media:
Jordona Jackson Smith

Jordona@jacksonbio.com
(805) 674-7347

Investors:
Chris Brinzey

chris.brinzey@westwicke.com
(339) 970-2843