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Biodesix Announces New Data on the VeriStrat® Test to be Presented at the 2025 ASCO Annual Meeting

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Biodesix (NASDAQ: BDSX) announced new data from the INSIGHT study on their VeriStrat Host Immune Classifier (HIC) test will be presented at the 2025 ASCO Annual Meeting. The study, involving over 5,000 NSCLC patients, demonstrates the test's ability to predict overall survival in non-small cell lung cancer patients receiving immunotherapy.

Key findings show that patients with VeriStrat Poor results had significantly improved survival when receiving combined immunotherapy and chemotherapy versus immunotherapy alone, with two-year survival rates more than tripling. Patients with VeriStrat Good results showed comparable survival with either treatment. Preliminary results suggest potential applications for other solid tumors, with additional data expected later in 2025.

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Positive

  • VeriStrat test showed significant predictive ability for treatment outcomes in NSCLC patients
  • Two-year survival rate more than tripled in VeriStrat Poor patients with combined therapy
  • Potential expansion of VeriStrat test application to other solid tumors
  • Large-scale validation through INSIGHT study with over 5,000 patients

Negative

  • None.

News Market Reaction

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On the day this news was published, BDSX declined 3.74%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

New data from the INSIGHT study demonstrates the VeriStrat Host Immune Classifier (HIC)’s ability to predict overall survival in patients with non-small cell lung cancer treated with immunotherapy

LOUISVILLE, Colo., May 22, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, announced today that new data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois at 2:30 pm ET on Saturday, May 31st. The presentation titled “Host immune classifier to predict survival with chemoimmunotherapy in PD-L1 ≥50% metastatic NSCLC” features data from the INSIGHT study (NCT03289780) which enrolled greater than 5,000 patients with non-small cell lung cancer (NSCLC). The data will be presented by Dr. Vamsidhar Velcheti, MD, Director of Thoracic Oncology at NYU Langone’s Perlmutter Cancer Center.

The VeriStrat test measures a patient’s immune response to lung cancer and is reported as either Host Immune Classifier Hot (VeriStrat Good) or Host Immune Classifier Cold (VeriStrat Poor). The new data strengthens prior findings and demonstrates statistically significant improvement of overall survival (OS) in patients with a VeriStrat Poor result when receiving immunotherapy combined with chemotherapy versus immunotherapy as a single agent. Notably, the two-year survival rate was more than three times higher in patients receiving immunotherapy plus chemotherapy compared to those who received immunotherapy alone. Additionally, patients with a VeriStrat Good result had comparable survival when receiving either treatment regimen.

“Immunotherapy treatments represent one of the most important recent innovations in lung cancer treatment, unfortunately some patients do not respond to these treatments while others may experience adverse reactions,” said Gary Pestano, Ph.D., Chief Development Officer, Biodesix. “This new data suggests that the VeriStrat test has the potential to help oncologists evaluate the benefits and risks of certain treatments for specific patients. The VeriStrat test may then be an aid in decision-making on whether to escalate or de-escalate treatment and improve patient outcomes.”

Preliminary results from a different ongoing study suggest that the VeriStrat test may have similar indications in patients with other types of solid tumors. Data from this study is expected to be published later in 2025.

About Biodesix

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com.

Trademarks: Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix, Inc.

Contacts:
Media:
Natalie St. Denis, Director Corporate Communications, Biodesix
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, ICR Healthcare
chris.brinzey@icrhealthcare.com
(339) 970-2843


FAQ

What are the key findings of Biodesix's INSIGHT study for BDSX stock?

The INSIGHT study showed VeriStrat test can predict survival outcomes in NSCLC patients, with VeriStrat Poor patients showing 3x higher two-year survival rates when receiving combined immunotherapy and chemotherapy versus immunotherapy alone.

How does Biodesix's VeriStrat test work for lung cancer patients?

VeriStrat measures a patient's immune response to lung cancer, classifying results as either Host Immune Classifier Hot (VeriStrat Good) or Host Immune Classifier Cold (VeriStrat Poor) to help guide treatment decisions.

What is the market potential for Biodesix's VeriStrat test?

Beyond its current use in non-small cell lung cancer, preliminary results suggest VeriStrat may be applicable for other solid tumors, with additional data expected later in 2025.

When will Biodesix present the new VeriStrat data at ASCO 2025?

Biodesix will present the new VeriStrat data at 2:30 pm ET on Saturday, May 31st, 2025, at the ASCO Annual Meeting in Chicago.

What is the clinical significance of Biodesix's VeriStrat test results?

The test helps oncologists evaluate treatment benefits and risks, aiding in decisions to escalate or de-escalate treatment between immunotherapy alone or combined with chemotherapy to improve patient outcomes.
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