Identifai-Genetics Launches Its 1st U.S. Clinical Trial | Led by Professor Ronald Wapner

Identifai-Genetics

Identifai-Genetics, developer of unique AI-based solutions for non-invasive fetal DNA sequencing, announced today that it has launched its first US clinical trial, in collaboration with Columbia University and the Columbia University Irving Medical Center in New York.

Revolutionizing Pregnancy Safety and Prenatal Testing

Identifai is revolutionizing pregnancy safety and prenatal testing by offering the first solution for non-invasive whole-genome sequencing of the fetus, using a blood test from the mother during the first trimester of pregnancy. Identifai’s platform and diagnostic tools enable early detection of the whole spectrum of fetal genetic disorders in an accessible, cost-effective and risk-free manner.

Clinical Study

Identifai’s US clinical study is aimed at demonstrating the performance and effectiveness of the company’s novel technology in real-world scenarios within the United States. Additionally, the study will serve as an analytic validity study, marking a prominent milestone in the regulatory pathway of the company’s first product line.

Cohort Study

The study cohort will include 100 pregnant women; its main arm will focus on anomalies known as autosomal recessive monogenic disorders. In these disorders, a gene is affected by distinct pathogenic variations in the DNA of the mother and the father. A single variation might not cause a disease, but inheriting the variations from both parents could lead to a severe fetal anomaly. These scenarios represent a significant segment of fetal genetic diseases, with prevalence of at-risk couples reaching 5% in specific populations.

Principal Investigator

The principal investigator in the study is world-renowned Professor Ronald J. Wapner, Director of Reproductive Genetics and Professor of Obstetrics and Gynecology at Columbia University Irving Medical Center. Prof. Wapner is a pioneering figure in prenatal testing, having played a pivotal role in the development and initial clinical trials of chorionic villus sampling procedures and chromosomal microarray analysis. The overseeing management will be done by Jessica Giordano, Assistant Professor of Genetic Counseling, the Associate Director of Women’s Genetics Research at Columbia University and an investigator in the study.

Dr. Amir Beker, Identifai’s CEO, stated:

“We take immense pride in launching Identifai’s inaugural US clinical trial in partnership with Columbia University, spearheaded by the esteemed Prof. Wapner, a global leader in the NIPT field. This study marks a critical milestone in transforming Identifai’s technology into a clinical offering accessible to millions of women in the US and across the globe”.

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