Important New Findings Validate Testing Strategies That Support Decision Making for Treatment of Patients with Non-Small Cell Lung Cancer (NSCLC)

BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, 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 featured at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), scheduled for January 28-31, 2021. Findings from these recent studies demonstrate that an individual patient’s immune profile can provide information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

MA08.03: Immunotherapy alone or with chemotherapy in advanced NSCLC? Utility of clinical factors and blood-based host immune profiling.

An abstract authored by Wallace Akerley, MD, of the University of Utah Huntsman Cancer Institute demonstrates that host immune classifier (HIC) testing can equip physicians with key information to help guide treatment decisions for patients with newly diagnosed advanced NSCLC.

The prospectively designed INSIGHT observational study (NCT03289780) found that a clinically validated, blood-based HIC successfully helped to predict Immune Checkpoint Inhibition (ICI) therapy outcomes. The HIC test accurately stratified survival for patients receiving ICI but not ICI in addition to platinum-doublet chemotherapy. This suggests that HIC testing can be used to determine the appropriate treatment course for advanced NSCLC patients by identifying patients who may benefit from more aggressive treatment strategies, including ICI plus platinum-based chemotherapy combinations. The highly anticipated abstract for this presentation is part of the conference press program, and therefore under embargo until the presentation at 3:45 a.m. EST on January 30, 2021.

P33.06: Utilizing serum proteome to understand response and resistance to immune checkpoint inhibitors in advanced non-small cell lung cancer

An abstract presented by Won Kyung Hur, MD, of Olive View-UCLA Medical Center, reports data from a study on the Primary Immune Response (PIR) test, a proteomic classifier that identifies an aggressive disease state associated with resistance to ICI therapy. While treatment options for patients with advanced NSCLC have evolved significantly with the introduction of ICI, many patients develop either primary or secondary resistance to ICI, making them unable to benefit from this therapy. Response and resistance to ICI treatment for NSCLC are poorly understood.

This presentation will report findings from an independent validation of the PIR test, led by Young Kwang Chae, MD, which identifies an aggressive NSCLC disease state associated with resistance to ICI therapy. Findings from the study suggest that the PIR test can help predict patient survival with ICI therapy and guide treatment decisions for patients with advanced NSCLC. The data will be available for viewing at 11:00 a.m. EST on January 27, and Dr. Hur will present the data on January 28, 2021.

FP07.17: The Impact of Blood Based Host Immune Profile to Identify Aggressive Early Stage NSCLC

The abstract, authored by Eric Schaefer, MD, of Highlands Oncology Group, reports findings from the INSIGHT study, which is evaluating the utility of the Biodesix Lung Reflex testing strategy. The data suggest that using blood-based immune profiling with proteomic testing can help to identify patients with aggressive lung disease at an early stage. This early identification can benefit patients significantly by prompting either enhanced surveillance or additional treatment and may lead to more accurate determination of patient prognosis and classification of disease stages. Dr. Schaefer will present the data on January 28, 2021.

“These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC,” said Scott Hutton, CEO of Biodesix. “By pursuing personalized testing approaches to help guide treatment decisions, we strive to help prevent patients from receiving ineffective and costly care. More than ever, we’re focused on and committed to relentlessly seeking the best treatment plan for every patient with lung cancer. We are tremendously proud to share these new and important study results with the medical community.”

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, it’s 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 quarterly report on Form 10Q, filed December 10, 2020. 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 Contact:
Jordona Jackson Smith

[email protected]
805-674-7347

Investors:
Jeremy Feffer

[email protected]
212-915-2568

Important New Findings Validate Testing Strategies That Support Decision Making for Treatment of Patients with Non-Small Cell Lung Cancer (NSCLC)

BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, 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 featured at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), scheduled for January 28-31, 2021. Findings from these recent studies demonstrate that an individual patient’s immune profile can provide information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

MA08.03: Immunotherapy alone or with chemotherapy in advanced NSCLC? Utility of clinical factors and blood-based host immune profiling.

An abstract authored by Wallace Akerley, MD, of the University of Utah Huntsman Cancer Institute demonstrates that host immune classifier (HIC) testing can equip physicians with key information to help guide treatment decisions for patients with newly diagnosed advanced NSCLC.

The prospectively designed INSIGHT observational study (NCT03289780) found that a clinically validated, blood-based HIC successfully helped to predict Immune Checkpoint Inhibition (ICI) therapy outcomes. The HIC test accurately stratified survival for patients receiving ICI but not ICI in addition to platinum-doublet chemotherapy. This suggests that HIC testing can be used to determine the appropriate treatment course for advanced NSCLC patients by identifying patients who may benefit from more aggressive treatment strategies, including ICI plus platinum-based chemotherapy combinations. The highly anticipated abstract for this presentation is part of the conference press program, and therefore under embargo until the presentation at 3:45 a.m. EST on January 30, 2021.

P33.06: Utilizing serum proteome to understand response and resistance to immune checkpoint inhibitors in advanced non-small cell lung cancer

An abstract presented by Won Kyung Hur, MD, of Olive View-UCLA Medical Center, reports data from a study on the Primary Immune Response (PIR) test, a proteomic classifier that identifies an aggressive disease state associated with resistance to ICI therapy. While treatment options for patients with advanced NSCLC have evolved significantly with the introduction of ICI, many patients develop either primary or secondary resistance to ICI, making them unable to benefit from this therapy. Response and resistance to ICI treatment for NSCLC are poorly understood.

This presentation will report findings from an independent validation of the PIR test, led by Young Kwang Chae, MD, which identifies an aggressive NSCLC disease state associated with resistance to ICI therapy. Findings from the study suggest that the PIR test can help predict patient survival with ICI therapy and guide treatment decisions for patients with advanced NSCLC. The data will be available for viewing at 11:00 a.m. EST on January 27, and Dr. Hur will present the data on January 28, 2021.

FP07.17: The Impact of Blood Based Host Immune Profile to Identify Aggressive Early Stage NSCLC

The abstract, authored by Eric Schaefer, MD, of Highlands Oncology Group, reports findings from the INSIGHT study, which is evaluating the utility of the Biodesix Lung Reflex testing strategy. The data suggest that using blood-based immune profiling with proteomic testing can help to identify patients with aggressive lung disease at an early stage. This early identification can benefit patients significantly by prompting either enhanced surveillance or additional treatment and may lead to more accurate determination of patient prognosis and classification of disease stages. Dr. Schaefer will present the data on January 28, 2021.

“These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC,” said Scott Hutton, CEO of Biodesix. “By pursuing personalized testing approaches to help guide treatment decisions, we strive to help prevent patients from receiving ineffective and costly care. More than ever, we’re focused on and committed to relentlessly seeking the best treatment plan for every patient with lung cancer. We are tremendously proud to share these new and important study results with the medical community.”

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, it’s 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 quarterly report on Form 10Q, filed December 10, 2020. 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 Contact:
Jordona Jackson Smith

[email protected]
805-674-7347

Investors:
Jeremy Feffer

[email protected]
212-915-2568

Important New Findings Validate Testing Strategies That Support Decision Making for Treatment of Patients with Non-Small Cell Lung Cancer (NSCLC)

BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, 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 featured at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), scheduled for January 28-31, 2021. Findings from these recent studies demonstrate that an individual patient’s immune profile can provide information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

MA08.03: Immunotherapy alone or with chemotherapy in advanced NSCLC? Utility of clinical factors and blood-based host immune profiling.

An abstract authored by Wallace Akerley, MD, of the University of Utah Huntsman Cancer Institute demonstrates that host immune classifier (HIC) testing can equip physicians with key information to help guide treatment decisions for patients with newly diagnosed advanced NSCLC.

The prospectively designed INSIGHT observational study (NCT03289780) found that a clinically validated, blood-based HIC successfully helped to predict Immune Checkpoint Inhibition (ICI) therapy outcomes. The HIC test accurately stratified survival for patients receiving ICI but not ICI in addition to platinum-doublet chemotherapy. This suggests that HIC testing can be used to determine the appropriate treatment course for advanced NSCLC patients by identifying patients who may benefit from more aggressive treatment strategies, including ICI plus platinum-based chemotherapy combinations. The highly anticipated abstract for this presentation is part of the conference press program, and therefore under embargo until the presentation at 3:45 a.m. EST on January 30, 2021.

P33.06: Utilizing serum proteome to understand response and resistance to immune checkpoint inhibitors in advanced non-small cell lung cancer

An abstract presented by Won Kyung Hur, MD, of Olive View-UCLA Medical Center, reports data from a study on the Primary Immune Response (PIR) test, a proteomic classifier that identifies an aggressive disease state associated with resistance to ICI therapy. While treatment options for patients with advanced NSCLC have evolved significantly with the introduction of ICI, many patients develop either primary or secondary resistance to ICI, making them unable to benefit from this therapy. Response and resistance to ICI treatment for NSCLC are poorly understood.

This presentation will report findings from an independent validation of the PIR test, led by Young Kwang Chae, MD, which identifies an aggressive NSCLC disease state associated with resistance to ICI therapy. Findings from the study suggest that the PIR test can help predict patient survival with ICI therapy and guide treatment decisions for patients with advanced NSCLC. The data will be available for viewing at 11:00 a.m. EST on January 27, and Dr. Hur will present the data on January 28, 2021.

FP07.17: The Impact of Blood Based Host Immune Profile to Identify Aggressive Early Stage NSCLC

The abstract, authored by Eric Schaefer, MD, of Highlands Oncology Group, reports findings from the INSIGHT study, which is evaluating the utility of the Biodesix Lung Reflex testing strategy. The data suggest that using blood-based immune profiling with proteomic testing can help to identify patients with aggressive lung disease at an early stage. This early identification can benefit patients significantly by prompting either enhanced surveillance or additional treatment and may lead to more accurate determination of patient prognosis and classification of disease stages. Dr. Schaefer will present the data on January 28, 2021.

“These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC,” said Scott Hutton, CEO of Biodesix. “By pursuing personalized testing approaches to help guide treatment decisions, we strive to help prevent patients from receiving ineffective and costly care. More than ever, we’re focused on and committed to relentlessly seeking the best treatment plan for every patient with lung cancer. We are tremendously proud to share these new and important study results with the medical community.”

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, it’s 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 quarterly report on Form 10Q, filed December 10, 2020. 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 Contact:
Jordona Jackson Smith

[email protected]
805-674-7347

Investors:
Jeremy Feffer

[email protected]
212-915-2568