Conquering patient diseases with personalized diagnostics
Our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
We envision a world where patient diseases are conquered with the guidance of personalized diagnostics.
We focus on communication, collaboration, and cooperation within our Biodesix team. We do this by doing what we say we are going to do to build trust.
We act with urgency while we continually learn and adapt. We are inclusive and respect each other and those we serve.
We approach all interactions with patience, calmness, and composure. We value curiosity and diverse perspectives to foster innovation, resilience, and success.
Every team member has the opportunity and responsibility to work smarter, demonstrate a competitive spirit, challenge the status quo, and overcome obstacles.
We are relentless in how we contribute to the achievement of Biodesix Goals & Objectives, our Mission, and our Vision.
We are committed to excellence without compromise and to achieving more than others thought possible by taking calculated risks, and by being agile and proactive.
We persistently seek to enrich the experience of our teams, our partners, our patients, our customers, and our communities.
We think big and know that we have unlimited potential.
Labs
- New York State CLEP-approved
- CAP-accredited
- CLIA-certified
- ISO 13485-certified
Manufacturing
- FDA CGMP-registered manufacturing facility
Our scientists and laboratorians have the expertise to extract the DNA and RNA from multi-modal clinical samples and perform state-of-the-art molecular analysis. We use ultra-sensitive technologies to deliver in-depth genomic diagnostic insights.
Biodesix Clinical Studies
We are continuously publishing and presenting new data on the clinical validation and utility of our diagnostic tests.
ALTITUDE Clinical Utility Study (NCT04171492)
The ALTITUDE clinical utility study is designed to evaluate the performance of Nodify Lung® testing (Nodify XL2® and Nodify CDT® tests) in a randomized controlled study (RCT). The study is titled “A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules”. The study objectives are to evaluate how the addition of the Nodify Lung test result impacts the clinical decision making for patients with new, incidentally identified solid lung nodules assessed as low to moderate risk of lung cancer.
CLARIFY Clinical Study (NCT06728319)
CLARIFY is a large, retrospective study assessing the performance of the Nodify CDT and Nodify XL2 tests in a real-world patient population. The study is titled “A Multicenter, Retrospective, Chart Review Study Evaluating The Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real World.” The study's primary objective is to assess the performance of the Nodify CDT and Nodify XL2 tests both individually and serially. The study will evaluate up to 4,000 patients who have at least 1-2 years of follow-up from high-volume community and academic practices that have integrated the testing into their management of lung nodules. It received central IRB approval in August 2024 and began enrollment in September 2024.
INSIGHT Observational Study (NCT03289780)
The INSIGHT observational study is designed to evaluate the real-world clinical utility and performance of VeriStrat®, GeneStrat® ddPCR, and GeneStrat® NGS. The title is “Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer (INSIGHT)”. In June 2023, we completed the enrollment of 5,000 patients with non-small cell lung cancer. Final analysis with 3-year follow-up is estimated to be completed by 2026.