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: Recruiting
• 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.

Two (2) cohorts are planned to assess:

Cohort A: Cross sectional cohort evaluating clinical performance with enrollment up to 100 pregnant subjects across three (3) age groups conducted at clinical sites. Tests will be read and interpreted by the lay user. Blood will be collected at the time of testing for comparator method testing. Positive test results will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy.

Cohort A1: pre-menopausal women age 14-40

Cohort A2: peri-menopausal women age 41-55

Cohort A3: post-menopausal women age >55

Cohort B: Duplicate testing cohort designed to evaluate accuracy and precision in lay users. A subset of a minimum of 100 participants from Cohort A will co-enroll into Cohort B and conduct duplicate testing using the First To Know® Pregnancy test. Participants will independently self-administer two tests consecutively and visually interpret the results without assistance.

Enrollment will reflect the observed prevalence of positive and negative pregnancy results in Cohort A, ensuring adequate representation across all age cohorts (pre-menopausal, peri-menopausal, and post-menopausal). The results from the first test will be used to assess accuracy, while the second test will evaluate precision and agreement with the first test.

• Study Type: Observational
• Enrollment (Estimated): 1705

Contacts and Locations

• Study Contact: Name: Monica Healy; Phone Number: 240-498-3933; Email: mhealy@mcra.com
• Study Contact Backup: Name: Crystal Casto, MS; Phone Number: 984-397-5163; Email: ccasto@mcra.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • Recruiting
      • Matrix Clinical Research Los Angeles
      • Contact: Ivette Cabrera; Phone Number: 310-424-5922; Email: ivette@matrixcr.com
      • Principal Investigator: Peyman Banooni, MD
      • Contact: Stan Gershovich; Phone Number: 310-424-5922; Email: stan.gershovich@matrixcr.com
  • Texas
    • Midland, Texas, United States, 79707
      • Recruiting
      • Era Health Research
      • Contact: Hinali Zaveri, MD; Phone Number: 3236 432-203-3236; Email: hzaveri@erahealthresearch.com
      • Principal Investigator: Sapna Chilka, MD

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)
• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; For this observational trial , the Intervention of interest is the First To Know Pregnancy 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; For this observational trial , the Intervention of interest is the First To Know Pregnancy 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; For this observational trial , the Intervention of interest is the First To Know Pregnancy 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; For this observational trial , the Intervention of interest is the First To Know Pregnancy 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; For this observational trial , the Intervention of interest is the First To Know Pregnancy 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; 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
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 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 (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 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): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

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