Clinical Trial

First To Know Pregnancy Test - Clinical Evaluation Protocol

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 26, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is evaluating the ADEXUSDx® hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know® (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.
Trial Details
NCT Number NCT07304531
Lead Sponsor NOWDiagnostics, Inc.
Collaborators: MCRA
Conditions Pregnancy Detection
Enrollment 1,705 participants
Start Date 2025-10-14
Primary Completion 2026-04 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-26