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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.

Biodesix (NASDAQ: BDSX) ha annunciato che nuovi dati dello studio INSIGHT sul loro test VeriStrat Host Immune Classifier (HIC) saranno presentati al Congresso Annuale ASCO 2025. Lo studio, che ha coinvolto oltre 5.000 pazienti con NSCLC, dimostra la capacità del test di prevedere la sopravvivenza globale nei pazienti con carcinoma polmonare non a piccole cellule trattati con immunoterapia.

I risultati principali evidenziano che i pazienti con risultati VeriStrat Poor hanno mostrato una sopravvivenza significativamente migliorata con la combinazione di immunoterapia e chemioterapia rispetto all'immunoterapia da sola, con tassi di sopravvivenza a due anni più che triplicati. I pazienti con risultati VeriStrat Good hanno mostrato una sopravvivenza simile con entrambi i trattamenti. I risultati preliminari suggeriscono potenziali applicazioni anche per altri tumori solidi, con ulteriori dati attesi entro la fine del 2025.

Biodesix (NASDAQ: BDSX) anunció que nuevos datos del estudio INSIGHT sobre su prueba VeriStrat Host Immune Classifier (HIC) serán presentados en la Reunión Anual ASCO 2025. El estudio, que involucró a más de 5,000 pacientes con NSCLC, demuestra la capacidad de la prueba para predecir la supervivencia global en pacientes con cáncer de pulmón no microcítico que reciben inmunoterapia.

Los hallazgos clave muestran que los pacientes con resultados VeriStrat Poor tuvieron una supervivencia significativamente mejorada al recibir inmunoterapia combinada con quimioterapia en comparación con la inmunoterapia sola, con tasas de supervivencia a dos años que se triplicaron con creces. Los pacientes con resultados VeriStrat Good mostraron una supervivencia comparable con cualquiera de los tratamientos. Los resultados preliminares sugieren aplicaciones potenciales para otros tumores sólidos, con datos adicionales esperados para finales de 2025.

Biodesix (NASDAQ: BDSX)VeriStrat Host Immune Classifier (HIC) 검사에 관한 INSIGHT 연구의 새로운 데이터를 2025년 ASCO 연례회의에서 발표할 예정이라고 밝혔습니다. 5,000명 이상의 NSCLC 환자를 대상으로 한 이 연구는 비소세포폐암 환자에서 면역치료를 받는 환자의 전체 생존율을 예측하는 검사 능력을 입증했습니다.

주요 결과에 따르면 VeriStrat Poor 결과를 가진 환자들은 면역치료 단독보다 면역치료와 화학요법 병용 시 생존율이 크게 향상되었으며, 2년 생존율이 세 배 이상 증가했습니다. VeriStrat Good 결과를 가진 환자들은 두 치료법 모두에서 유사한 생존율을 보였습니다. 예비 결과는 다른 고형 종양에 대한 잠재적 적용 가능성을 시사하며, 추가 데이터는 2025년 후반에 발표될 예정입니다.

Biodesix (NASDAQ : BDSX) a annoncé que de nouvelles données de l'étude INSIGHT sur leur test VeriStrat Host Immune Classifier (HIC) seront présentées lors de la réunion annuelle ASCO 2025. L'étude, impliquant plus de 5 000 patients atteints de NSCLC, démontre la capacité du test à prédire la survie globale chez les patients atteints de cancer du poumon non à petites cellules recevant une immunothérapie.

Les résultats clés montrent que les patients avec des résultats VeriStrat Poor ont une survie significativement améliorée lorsqu'ils reçoivent une immunothérapie combinée à une chimiothérapie par rapport à l'immunothérapie seule, avec des taux de survie à deux ans plus que triplés. Les patients avec des résultats VeriStrat Good ont montré une survie comparable avec l'un ou l'autre traitement. Les résultats préliminaires suggèrent des applications potentielles pour d'autres tumeurs solides, avec des données supplémentaires attendues d'ici la fin 2025.

Biodesix (NASDAQ: BDSX) gab bekannt, dass neue Daten aus der INSIGHT-Studie zu ihrem VeriStrat Host Immune Classifier (HIC)-Test auf der ASCO-Jahrestagung 2025 präsentiert werden. Die Studie mit über 5.000 NSCLC-Patienten zeigt die Fähigkeit des Tests, das Gesamtüberleben von Patienten mit nicht-kleinzelligem Lungenkarzinom unter Immuntherapie vorherzusagen.

Wesentliche Ergebnisse zeigen, dass Patienten mit VeriStrat Poor-Ergebnissen eine signifikant verbesserte Überlebensrate bei kombinierten Immun- und Chemotherapien gegenüber der alleinigen Immuntherapie aufwiesen, wobei die Zweijahresüberlebensraten mehr als verdreifacht wurden. Patienten mit VeriStrat Good-Ergebnissen zeigten eine vergleichbare Überlebensrate bei beiden Behandlungsformen. Vorläufige Ergebnisse deuten auf potenzielle Anwendungen bei anderen soliden Tumoren hin, weitere Daten werden für Ende 2025 erwartet.

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.

Insights

Biodesix's VeriStrat test shows significant survival benefit prediction for lung cancer patients, potentially guiding immunotherapy treatment decisions.

The new INSIGHT study data demonstrates that Biodesix's VeriStrat Host Immune Classifier (HIC) test can effectively stratify non-small cell lung cancer (NSCLC) patients for treatment optimization. This is particularly noteworthy as it addresses a critical clinical challenge in immunotherapy treatment.

The most compelling finding is that patients with a VeriStrat Poor result showed statistically significant improvement in overall survival when receiving combination therapy (immunotherapy plus chemotherapy) versus immunotherapy alone. The two-year survival rate was over three times higher in the combination therapy group - a dramatic difference that could significantly impact treatment protocols.

Equally important, patients with a VeriStrat Good classification had comparable survival rates regardless of treatment regimen, suggesting these patients might avoid unnecessary chemotherapy toxicity without compromising outcomes.

This biomarker approach represents an important advancement in precision oncology. Current PD-L1 testing alone has limitations in predicting immunotherapy response. The VeriStrat test appears to measure the host immune response to cancer, potentially offering complementary information to existing biomarkers.

The mention of preliminary results showing similar indications in other solid tumors suggests broader potential applications beyond lung cancer, which could substantially expand the test's clinical utility and commercial potential.

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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