Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Pediatrics/Neonatology | Pharmacology/Toxicology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 1997
Treatment Area: chromosomal abnormalities
AneuVysion Assay, the first prenatal genetic test for Down
syndrome and other chromosomal disorders associated with mental
retardation and birth defects, has been approved by the FDA. The
AneuVysion Assay is designed for routine use as an adjunct to
standard cytogenic analysis. The test--a multicolored DNA probe
panel--also can be used alone in medically urgent situations.
In a pivotal comparative study of the AneuVysion Assay at 31
clinical sites, 2,238 specimens were analyzed from 1,516 patients.
Analysis of the AneuVysion Assay on interphase nuclei was compared
with standard cytogenic analysis. Based on the cutoff point of 60
percent aneuploid nuclei, the test's relative sensitivity was
99.9 percent, and specificity was 100 percent for detecting Down
syndrome, trisomy 18, and trisomy 13, and other sex-linked
chromosomal disorders, including Turner and Kleinfelter