A potential best-in-class decision support diagnostic in lung cancer. LungLB identifies genetic aberrations indicative of lung cancer in cells from a peripheral blood draw, supported by imaging AI. A 149-patient, prospective Pilot Study (on samples from MD Anderson Cancer Center and Mount Sinai) demonstrated sensitivity of 76%, specificity of 71% and a positive predictive value of 89%, a balanced performance appropriate for the intended setting. Validation Study preparations underway. A 425-patient, prospective Validation Study (start Q3 2021e) will be performed to support commercial launch (initially as a Laboratory Developed Test), FDA clearance (2023e), and US payer discussions. Subject to positive data, we anticipate a high level of interest from payers and practitioners as LungLB is differentiated from existing approaches in terms of cost and utility, especially in early-stage disease. We estimate peak US sales potential of 160,000 tests pa. We assume initial launch as decision support for improved management of indeterminate lung nodules, around 1.6m of which are detected in the US annually, with future potential in post-surgical monitoring. We assume reimbursement at $950/test and expanding Medicare and private payer coverage post launch. Potential Breakthrough Device designation (2022e) would support an accelerated regulatory path and nationwide Medicare coverage. Attractive valuation. Our 261p target price is based on a 12-year risk-adjusted NPV, using a 7% discount rate and a progressive probability adjustment related to expected regulatory and commercial progress. Buy.