Pregnancy DetectionNCT07304531
First To Know Pregnancy Test - Clinical Evaluation Protocol
An observational study of Pregnancy Detection, run by NOWDiagnostics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Detection
- What is being tested?
- Diagnostic Test
- Type of treatment
- Medical device
- How many people
- 892 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2025to 7 May 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female residents of the United States who elect to participate in the study.
Who may be able to join
- 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
Who cannot join
- Males
- Females <14 years of age
- People with limited or no reading skills
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Matrix Clinical Research Los Angeles
Los Angeles, California, 90057
ERA Health Research
Midland, Texas, 79707
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Detection
- Being tested
- Diagnostic Test
- Keywords
- NOWDx First To Know Pregnancy Detection Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestDevice
For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Diagnostic Test | |
| Cohort B: Duplicate Testing Cohort | Subset of Cohort A will be enrolled for duplicate testing. Receives: Device: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start14 Oct 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 892 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- NOWDiagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304531
- Sponsor's protocol ID
- CR-STDY-8001-01
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First To Know Pregnancy Test Clinical Evaluation Protocol
- ClinicalTrials.gov ID
- NCT07304531
- Acronym / sponsor ID
- CR-STDY-8001-01
- Conditions
- Pregnancy Detection
- Keywords
- NOWDx First To Know Pregnancy Detection Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- NOWDiagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Women of unknown pregnancy status | – | Device: Diagnostic TestParticipants 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. |
| Cohort B: Duplicate Testing Cohort | – | Device: Diagnostic TestSubset of Cohort A will be enrolled for duplicate testing. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female residents of the United States who elect to participate in the study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Males
- Females <14 years of age
- People with limited or no reading skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestFor this observational trial , the Intervention of interest is the First To Know Pregnancy Test | Device | Cohort A: Women of unknown pregnancy status, Cohort B: Duplicate Testing Cohort |
Primary outcome
First To Know Pregnancy test OTC evaluation
Time frame: Through study completion, an average of 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Detection
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
Recruiting
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Detection, run by NOWDiagnostics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First To Know Pregnancy test OTC evaluation (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.