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Variantyx Enters Women’s Health Market with WGS-Based Prenatal Test for High-Risk Pregnancies

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Variantyx announced today that it will launch its Genomic Unity® Prenatal Analysis test at the Society for Maternal Fetal Medicine’s 41st Annual Pregnancy Meeting being held virtually January 25-30.

Its Genomic Unity® tests have been instrumental in resolving many complex patient cases. Variantyx pairs the patient’s complete DNA sequence with proprietary data analysis algorithms and phenotype-driven filters to uniquely identify and definitively report on all major types of genetic variation within a single assay. Including genome-wide small sequence changes, structural variants, mitochondrial variants and tandem repeat expansions.

With this introduction of the Genomic Unity® Prenatal Analysis test, Variantyx is applying the same comprehensive testing approach that it has used successfully in pediatric and adult settings to high-risk pregnancies where ultrasound anomalies have been identified.

“A routine prenatal ultrasound will identify fetal structural anomalies ranging from mild to severe in approximately 3% of pregnancies. Obtaining a molecular diagnosis in these cases is critical for ensuring appropriate prenatal and perinatal clinical management,” said Dr. Allan J. Fisher, FACOG, FACMG, Variantyx Medical Director and Professor at St. Louis University School of Medicine. “Exome sequencing of fetuses with structural anomalies have generated promising results in recent years. Variantyx takes the power of such an approach to the next level.”

Fisher added, “Their whole genome sequencing (WGS) methodology accurately identifies challenging variant types that would be missed by other tests including copy number variants, short tandem repeats, Alu insertions, inversions, single exon deletions, and mosaic aneuploidy, providing more comprehensive answers for clinicians and patients. We have been waiting more than 20 years, since the completion of the human genome project, to realize the full promise of fetal genetic molecular examination. It’s so exciting to have visibility into all of these variant types as part of a single test, instead of having to order separate tests.”

The test is performed using amniotic fluid paired with blood from both parents to provide an accurate and comprehensive genomic analysis of the fetus.

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