First To Know Pregnancy Test - Clinical Evaluation Protocol

Conditions

• Pregnancy Detection

Eligibility Criteria

Sex

FEMALE

Age

14 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Diagnostic Test — DEVICE
  For this observational trial , the Intervention of interest is the First To Know Pregnancy Test

Study Details

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.

Key Dates

Start date

Oct 14, 2025

Status verified

Dec 2025

Primary completion

Apr 30, 2026

Completion

May 31, 2026

Study Design

Enrollment

1,705 participants (estimated)

Arms

• Arm: Cohort A1 - Pre-menopausal women ages 14-40
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 14-40
• Arm: Cohort A2 - Peri-menopausal women ages 41-55
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 41-55
• Arm: Cohort A3 - Post-menopausal women ages >55
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, age over 55
• Arm: Cohort B1 - Subset of Cohort A1 Pre-menopausal women ages 14-40
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 14-40
• Arm: Cohort B1 - Subset of Cohort A2 - Peri-menopausal women ages 41-55
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 41-55
• Arm: Cohort B3 - Subset of Cohort A3 - Post-menopausal women ages >55
  Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, age over 55

Primary Outcome Measure

Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

• Monica Healy
  240-498-3933
  [email protected]
• Crystal Casto, MS
  984-397-5163
  [email protected]

Locations (2)

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