First To Know Pregnancy Test - Clinical Evaluation Protocol

NCT07304531 | Recruiting FDA Device

• 1 other identifier: CR-STDY-8001-01
• Study Type: observational
• Target: 1,705
• 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)

• Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay

  Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay (e.g., Siemens Dimension® hCG Flex® Reagent Cartridge, Roche Cobas® Elecsys HCG STAT) as the clinical comparator

  Through study completion, an average of 6 months

Secondary Outcomes (6)

• Assess the performance of the FTK Pregnancy test near the cutoff range

  Through study completion, an average of six months

• Evaluate the test's specificity in pre-menopausal, peri-menopausal and post-menopausal women

  through study completion, an average of 6 months

• Follow subjects to confirm pregnancy status

  through study completion, an average of 6 months

• Evaluate lay user performance under real-world conditions

  through study completion, an average of 6 months

• Assess the usability of the test

  through study completion, an average of 6 months

Study Arms (6)

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

Device: Diagnostic Test

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

Device: Diagnostic Test

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

Device: Diagnostic Test

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

Device: Diagnostic Test

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

Device: Diagnostic Test

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

Device: Diagnostic Test

Interventions

Diagnostic Test DEVICE

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

Cohort A1 - Pre-menopausal women ages 14-40; Cohort A2 - Peri-menopausal women ages 41-55; Cohort A3 - Post-menopausal women ages >55; Cohort B1 - Subset of Cohort A1 Pre-menopausal women ages 14-40; Cohort B1 - Subset of Cohort A2 - Peri-menopausal women ages 41-55; Cohort B3 - Subset of Cohort A3 - Post-menopausal women ages >55

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)
• Age Selection - must meet one of the following age groups:
• Cohort A1 - Pre-menopausal: ≥14 years of age and ≤ 40 years of age with menstrual cycles (cycle lengths of 25-35 days)
• Cohort A2 - Peri-menopausal: ≥41 years of age and ≤ 54 years of age
• Cohort A3 - Post-menopausal: ≥55 years of age
• 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
• Recent pregnancy within the past 6 months
• Trophoblastic disease or non-trophoblastic neoplasms
• Downs syndrome (trisomy 21)
• People with limited or no reading skills
• Amenorrhea not related to peri or post menopause
• Use of medications or hormonal contraceptives that may interfere with hCG levels at the time of testing (e.g., Gonadotropins: Luteinizing hormone)

Sponsors & Collaborators

• MCRA: collaborator
• NOWDiagnostics, Inc.: lead

Study Sites (2)

Matrix Clinical Research Los Angeles

Los Angeles, California, 90057, United States

RECRUITING

ERA Health Research

Midland, Texas, 79707, United States

RECRUITING

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Monica Healy

CONTACT

240-498-3933; mhealy@mcra.com

Crystal Casto, MS

CONTACT

984-397-5163; ccasto@mcra.com

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: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)