This section highlights FDA-related milestones and regulatory updates for drugs developed by Biodesix (BDSX).
Over the past two years, Biodesix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nodify and Nodify. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Nodify CDT® - FDA Regulatory Timeline and Events
Nodify CDT® is a drug developed by Biodesix for the following indication: blood-based lung nodule test.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nodify CDT®
- Announced Date:
- January 7, 2025
- Indication:
- blood-based lung nodule test.
Announcement
Biodesix, Inc. announced a new post-market clinical validation study was published in CHEST Pulmonary Journal that reaffirms the previously established performance of the Nodify CDT® blood-based lung nodule test.
AI Summary
Biodesix, Inc. announced the publication of a new post-market clinical validation study in CHEST Pulmonary Journal that reaffirms the performance of its Nodify CDT® blood-based lung nodule test. The study, which retrospectively evaluated 447 patients with lung nodules managed by conventional care, noted that 33% of patients with cancerous nodules were diagnosed more than three months after detection—a delay that might have affected early intervention. The Nodify CDT test maintained a high specificity, minimizing the misclassification of benign nodules as high risk. In direct comparison with PET scans, which produced significantly more false-positive results and potentially unnecessary invasive procedures, the blood-based test demonstrated a clearer advantage. These findings support the test’s role as a valuable tool for refining lung nodule risk assessment and aiding clinicians in making timely, informed diagnostic decisions.
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Nodify XL2 - FDA Regulatory Timeline and Events
Nodify XL2 is a drug developed by Biodesix for the following indication: For patients with lung diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nodify XL2
- Announced Date:
- October 7, 2024
- Indication:
- For patients with lung diseases.
Announcement
Biodesix, Inc announced that new data will be presented at the CHEST Annual Meeting 2024 in Boston, Massachusetts on Tuesday, October 8 at 10:20 am ET. The presentation will detail the experience of healthcare providers using the Nodify Lung® Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting.
AI Summary
Biodesix, Inc. announced that new data will be presented at the CHEST Annual Meeting 2024 in Boston, Massachusetts, on Tuesday, October 8 at 10:20 am ET. The presentation will focus on how healthcare providers are using the Nodify Lung® Nodule Risk Assessment in a real-world clinical setting, based on data from over 35,000 consecutively tested patients. This blood-based test is designed to reclassify lung cancer risk, guiding clinicians when determining the best diagnostic and management paths for patients with lung nodules. By sharing the aggregate experience from a large patient cohort, the presentation will highlight real-world use patterns and the clinical impact of the test. This initiative underscores Biodesix’s commitment to supporting healthcare providers with robust data, ultimately aiming to improve clinical decision-making and patient outcomes in lung disease management.
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