Clinical Trial

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.

Study acronym: BA-004
Recruiting
View on ClinicalTrials.gov →
Summary
Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.
Protocol Amendment History 2 changes
notable Trial sites expanded: 7 -> 11 locations 2026-07-17
notable Trial sites expanded: 3 -> 7 locations 2026-06-11
Trial Details
NCT Number NCT07168993
Lead Sponsor bioAffinity Technologies Inc.
Collaborators: Precision Pathology Laboratory Services (PPLS), HiRO (Harvest Integrated Research Organization)
Conditions Lung Cancer (Diagnosis)
Enrollment 2,063 participants
Start Date 2026-02-25
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16