First To Know Pregnancy Test - Clinical Evaluation Protocol

First To Know Pregnancy Test Clinical Evaluation Protocol

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Detection
• Intervention / Treatment: Device: Diagnostic Test

Detailed Description

The Investigational First to Know® Pregnancy test has been adapted from the CLIA moderately complex, FDA-cleared ADEXUSDx® hCG test for clinical evaluation to enable lay users to self-test in a simulated home environment in the US. The First To Know® Pregnancy test is currently CE marked in the EU for OTC use. The assays remain identical in their formulation and performance characteristics.

The clinical evaluation includes lay users self-testing and additional blood being drawn for comparator testing. All negative test results will be followed up for outcome. All subjects with positive test results or reporting negative results later resulted in pregnancy will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy.

• Study Type: Observational
• Enrollment (Actual): 892

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research Los Angeles
  • Texas
    • Midland, Texas, United States, 79707
      • Era Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
Cohort B: Duplicate Testing Cohort; Subset of Cohort A will be enrolled for duplicate testing.	Device: Diagnostic Test; For this observational trial , the Intervention of interest is the First To Know Pregnancy Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the performance of the FTK Pregnancy test near the cutoff range	Calculate the sensitivity and specificity of the First To Know 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	Evaluate the test's specificity in pre-menopausal, peri-menopausal and post-menopausal women to assess false positives	through study completion, an average of 6 months
Follow subjects to confirm pregnancy status	Follow subjects to confirm pregnancy status to compute accuracy of the First To Know Pregnancy Test.	through study completion, an average of 6 months
Evaluate lay user performance under real-world conditions	Calculate invalid rate for lay users performing the First To Know Pregnancy test under real world conditions.	through study completion, an average of 6 months
Assess the usability of the test	Calculate useability statistics for lay users performing the First To Know Pregnancy test under real world conditions through their First To Know Pregnancy Useability Questionnaire Responses	through study completion, an average of 6 months
Evaluate testing precision	Compute concordance in duplicate tests performed by a subset of subjects.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: NOWDiagnostics, Inc.
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Actual): May 7, 2026
• Study Completion (Actual): May 7, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: NOWDx First To Know Pregnancy Detection Test
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Tests, Routine
• Other Study ID Numbers: CR-STDY-8001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No