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First To Know Pregnancy Test - Clinical Evaluation Protocol
Sponsor: NOWDiagnostics, Inc.
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.
Official title: First To Know Pregnancy Test Clinical Evaluation Protocol
Key Details
Gender
FEMALE
Age Range
14 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1705
Start Date
2025-10-14
Completion Date
2026-05
Last Updated
2025-12-26
Healthy Volunteers
Yes
Conditions
Interventions
Diagnostic Test
For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
Locations (2)
Matrix Clinical Research Los Angeles
Los Angeles, California, United States
ERA Health Research
Midland, Texas, United States