Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, >6 to <30 mm in Diameter, Determined by LDCT.

NANot yet recruitingINTERVENTIONAL

Enrollment

2,063

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

April 1, 2029

Study Completion Date

July 1, 2029

Conditions

Lung Cancer (Diagnosis)

Interventions

OTHER

Standard medical treatment

Standard of care follow up per institution

OTHER

Standard medical treatment

SOC per institution

All Listed Sponsors

lead

bioAffinity Technologies Inc.

INDUSTRY