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Genetic Testing

Non-Invasive Blood Test for Prenatal Genetic Diagnosis

N/A
Recruiting
Research Sponsored by Identifai Genetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parental age ≥18
Parents are both carriers of different known pathogenic SNVs or short indels (<=5bp) in the same gene (compound heterozygosity)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to confirm a new way to diagnose genetic conditions in unborn babies by testing the baby's genetic material found in the mother's blood.

Who is the study for?
This trial is for pregnant individuals who are interested in a noninvasive prenatal diagnosis to check for genetic conditions in their developing fetus. The study involves analyzing fetal DNA found in the mother's blood.
What is being tested?
The study is testing the accuracy of a new Non Invasive Prenatal Test (NIPT) that uses a blood sample from the pregnant individual to detect potential genetic issues in the fetus without any riskier invasive procedures.
What are the potential side effects?
Since this test only requires drawing blood, similar to routine blood tests during pregnancy, side effects are minimal and may include slight pain or bruising at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
Both my parents carry different known genetic mutations in the same gene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Analytic Validity - Sensitivity
Analytic Validity - Specificity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Identifai Genetics Analytic Validity - Compound Heterozygosity and Samples CollectionExperimental Treatment1 Intervention

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Who is running the clinical trial?

Identifai GeneticsLead Sponsor
~40 spots leftby Sep 2025
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