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RECRUITING
NCT07304531

First To Know Pregnancy Test - Clinical Evaluation Protocol

Sponsor: NOWDiagnostics, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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