First To Know pregnancy test for self-testing
First To Know Pregnancy Test Clinical Evaluation Protocol
This will test whether the First To Know pregnancy test works accurately when regular people self-test in a simulated home setting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1705 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | NOWDiagnostics, Inc. Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT07304531 on ClinicalTrials.gov |
What this trial studies
The protocol adapts the FDA-cleared ADEXUSDx hCG CLIA test into the First To Know format and asks lay users to perform self-testing in a simulated home environment at clinical sites in the US. Participants will perform the urine test themselves while blood is drawn for a laboratory comparator; positive results and any later-reported pregnancies will be confirmed with standard-of-care data. The plan includes cohorts across pre-, peri-, and post-menopausal age groups with up to 100 pregnant subjects and a duplicate-testing cohort of at least 100 participants to evaluate accuracy and precision. Negative results will be followed up to capture outcomes and verify true negatives.
Who should consider this trial
Good fit: Ideal candidates are sexually active females age 14 or older with unknown pregnancy status who are willing to self-test, provide samples, and share follow-up information.
Not a fit: People who are already certain of their pregnancy status, recently pregnant within the past 6 months, or male are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the test could provide an easy, reliable over-the-counter pregnancy test option for people to use at home.
How similar studies have performed: The underlying ADEXUSDx hCG assay is FDA-cleared for clinical use and the First To Know test is CE‑marked for OTC use in the EU, but US OTC performance is being specifically tested here.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California and 1 other locations
- Matrix Clinical Research Los Angeles — Los Angeles, California, United States (Recruiting)
- ERA Health Research — Midland, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Monica Healy
- Email: mhealy@mcra.com
- Phone: 240-498-3933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.