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Vysis gains US nod to change labelling of prenatal test

This article was originally published in Clinica

Executive Summary

The US FDA has given Vysis the go-ahead to change the labelling of its AneuVysion prenatal test to allow doctors to report results from the test immediately. Under previous regulations, AneuVysion results had to be withheld until routine cytogenetic test (foetal karyotyping) results - which generally takes 7-10 days - were also available, except in medically urgent situations. AneuVysion, a fluorescent in-situ hybridisation-based test, can provide results in 24 hours with an accuracy of 99.9%, claims the Downers Grove, Illinois company.

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