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New prenatal blood test aims to detect genetic disorders without invasive procedures

NCT ID NCT07643896

Diagnosis Sponsor: BillionToOne Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new blood test that looks for fetal cells in the mother's blood to detect genetic conditions like Down syndrome. The test will be compared to standard diagnostic methods such as amniocentesis or newborn testing. The study involves 1,000 pregnant individuals between 10 and 20 weeks of pregnancy with a single baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

pregnant individuals between 10 and 20 weeks of gestation with singleton pregnancies

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * pregnant individuals between 10 and 20 weeks of gestation * singleton gestation Exclusion Criteria: \- active cancer

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

22q11.2 deletion syndrome aneuploidy DiGeorge syndrome Down syndrome gonosome anomaly Sex Chromosome Aberrations trisomy 13 Trisomy 13 Syndrome trisomy 18 Trisomy 18 Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

22q11.2 deletion syndrome Aneuploidy Down syndrome (trisomy 21) Pregnant individuals Sex chromosome abnormalities Trisomy 13 Trisomy 18

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pediatrix Medical Group

    RECRUITING

    Houston, Texas, 773339, United States

  • Pediatrix Medical Group of Georgia

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • San Gabriel Valley Perinatal Medical Group

    RECRUITING

    West Covina, California, 91710, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Valley Perinatal Services

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • Woman's Hospital

    RECRUITING

    Baton Rouge, Louisiana, 70817, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.