AneuVysion Clinician Overview

AneuVysion tests for the most common genetic birth defects using the rapid and accurate fluorescence in situ hybridization (FISH) technology. This utilizes molecular genetic techniques to create a fluorescent DNA probe that produces a bright microscopic signal when it selectively attaches to one specific part of a particular chromosome. By counting the number of signals within a cell, the cytogenetic technologist knows whether the fetus has a normal number, trisomy, monosomy or other aneusomy of the detectable chromosomes. AneuVysion is intended to be used in conjunction with other information currently used in prenatal diagnosis, consistent with professional standards of practice, for woman with presumed high risk pregnancies.

The AneuVysion Test provides:

• Detection of the most common prenatal genetic birth defects
• Results in as little as 24 hours. AneuVysion Assay results can be reported to the physician within 24 to 48 hours from the time the laboratory receives the amniotic fluid specimen. Results from conventional cytogenetics should be available in 7 to 14 days; each laboratory has its own turn-around time which is dependent upon cell growth and laboratory workload.
• 99.9% accuracy in over 29,000 samples for abnormalities in chromosomes 13, 18, 21, X, and Y¹
• For In vitro Diagnostic Use

Reference

^1. Tepperberg J, Pettenati MJ, Rao PN et al. Prenatal diagnosis using interphase fluorescence in situ hybridization (FISH), 2-year multi-center retrospective study and review of the literature. Prenat Diag 2001; 21: 293-301.