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Quest’s fragile X test approved in New York

This article was originally published in Clinica

Executive Summary

Quest Diagnostics’ XSense test, which is used to screen for fragile X syndrome, has been approved by New York State’s department of health. The firm launched it in the rest of the US in February; however, New York has an independent regulatory review process for lab-developed tests. Fragile X syndrome is an inherited form of mental retardation caused by mutations in the FMR1 gene. XSense can be used to screen newborns or women of childbearing age, to identify carriers. Quest hopes that its test will replace the previous gold standard, the Southern blot, which is “labour intensive” and can take up to two weeks to produce results (www.clinica.co.uk, 14 April 2010). XSense, which uses triplet-primed PCR with capillary electrophoresis technology, takes around a week, Quest (Madison, New Jersey) said.

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