Biodesix targets 2028 launch for lung test
- Biodesix added Digital Diagnostics to its lung testing strategy, collaborating with Vanderbilt University and Vanderbilt Health on an AI-powered lung nodule risk test.
- The company received institutional review board approval for its STRATIFY study and plans to present initial test performance data on December 3, 2026.
- Biodesix anticipates launching its first radiomics-based diagnostic test in 2028 through its existing commercial channels, complementing its Nodify Lung portfolio.
Biodesix (NASDAQ:BDSX) announced plans to develop an AI-powered lung nodule risk test with Vanderbilt University and Vanderbilt Health, targeting commercial availability in 2028.
The initiative expands its existing Nodify Lung blood-test portfolio by combining imaging biomarkers, blood biomarkers and artificial intelligence to assess lung cancer risk.
The first planned test uses radiomics, which extracts measurable information from medical images to help evaluate suspicious lung nodules alongside existing blood-based assessments.
Biodesix received institutional review board approval for its STRATIFY study, expected to begin in Q4 2026, and established an Independent Diagnostic Testing Facility to support future testing.
The company expects to present initial performance data on December 3, 2026, and pursue commercialization in 2028.
Biodesix has engaged with the FDA regarding a potential regulatory pathway and Medicare regarding future commercialization, although neither regulatory clearance nor reimbursement approval was announced.
The company previously reported a 1,100-patient Nodify CDT validation analysis in March and announced additional lung nodule research presentations for CHEST 2026.
