First To Know Pregnancy Test - Clinical Evaluation Protocol

NCT07304531 | Completed FDA Device

• 1 other identifier: CR-STDY-8001-01
• Study Type: observational
• Target: 892
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Detection

Keywords

NOWDx First To Know Pregnancy Detection Test

Outcome Measures

Primary Outcomes (1)

• First To Know Pregnancy test OTC evaluation

  Evaluate the accuracy and sensitivity of the First To Know Pregnancy test in an OTC setting compared to a legally marketed quantitative blood-based hCG assay as the clinical comparator.

  Through study completion, an average of 6 months

Study Arms (2)

Cohort A: Women of unknown pregnancy status

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, and from different age groups.

Device: Diagnostic Test

Cohort B: Duplicate Testing Cohort

Subset of Cohort A will be enrolled for duplicate testing.

Device: Diagnostic Test

Interventions

Diagnostic Test DEVICE

For this observational trial , the Intervention of interest is the First To Know Pregnancy Test

Cohort A: Women of unknown pregnancy status; Cohort B: Duplicate Testing Cohort

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Cisgender females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female residents of the United States who elect to participate in the study.

You may qualify if:

• Females whose pregnancy status is unknown (e.g., have not used urine test at home)
• Not menstruating at the time of the initial study visit
• Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing
• Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit
• Sexually active
• Not using contraceptives
• English/Spanish speaking

You may not qualify if:

• Males
• Females \<14 years of age
• People with limited or no reading skills

Sponsors & Collaborators

• MCRA: collaborator
• NOWDiagnostics, Inc.: lead

Study Sites (2)

Matrix Clinical Research Los Angeles

Los Angeles, California, 90057, United States

Location

ERA Health Research

Midland, Texas, 79707, United States

Location

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: October 14, 2025
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)