Cell-Based Noninvasive Prenatal Testing (NIPT)

Luna Genetics

Status: Enrolling

Conditions: Pregnancy Related

Treatments: Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245266

Luna IRB LG-003

Details and patient eligibility

About

The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for healthy pregnant subjects:

• Pregnant
• 18 years or older
• 65 or younger

Exclusion Criteria for healthy pregnant subjects:

• Acute illness
• Unavailability of maternal blood sample of at least 30 ml
• Language barrier (non-English speaking )
• Maternal age of less than 18 years, or over 65
• Higher order multiple pregnancy (triplet or greater)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Analysis of blood samples from healthy pregnant women

Other group

Description:

Analysis of blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.

Treatment:

Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women