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NCT07304531 · ClinicalTrials.gov registry record
First To Know Pregnancy Test - Clinical Evaluation Protocol
A clinical trial of Pregnancy Detection, sponsored by NOWDiagnostics.
- Recruiting
- Registry status
- 1,705
- Enrollment target
- 2
- Study locations
NCT07304531: Recruiting study of Pregnancy Detection, sponsored by NOWDiagnostics.
NCT07304531 is a study of Pregnancy Detection that is actively recruiting participants, run by NOWDiagnostics. The registered enrollment target is 1,705 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07304531, a study of Pregnancy Detection, is actively recruiting participants, sponsored by NOWDiagnostics.
- RECRUITING
- Registry status
- 1,705 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Diagnostic Test
Study Locations (2)
California
- Matrix Clinical Research Los Angeles - Los Angeles
Texas
- ERA Health Research - Midland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,705 participants |
| Start Date | 2025-10-14 |
| Est. Completion | 2026-05 |
What NCT07304531 shows while recruiting
NCT07304531 is an observational study that tracks outcomes without assigning an intervention. Its 1,705 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Pregnancy Detection appearing as the primary indexed condition, and to 1 intervention - of which Diagnostic Test is the first listed.
NCT07304531 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT07304531 about?
NCT07304531 is a clinical study titled "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 populatio...
What is the current status of trial NCT07304531?
This trial is currently recruiting. The enrollment target is 1,705 participants. The study started on 2025-10-14. Estimated completion is 2026-05.
What conditions does trial NCT07304531 study?
This clinical trial studies the following conditions: Pregnancy Detection.
What interventions are being tested in trial NCT07304531?
The interventions under investigation include: Diagnostic Test (DEVICE).
Who is sponsoring clinical trial NCT07304531?
This trial is sponsored by NOWDiagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07304531 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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