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Luminex launches cystic fibrosis test

This article was originally published in Clinica

Executive Summary

Luminex has launched its xTAG Cystic Fibrosis 60 Kit v2 in the US, after recently receiving 510(k) approval from the FDA. The test is designed to screen couples planning a pregnancy, to determine whether they are carriers of genetic mutations that cause the disorder. It can simultaneously detect up to 60 gene variants in a single blood sample, "in a matter of hours", Luminex said. The Austin, Texas firm's previous version of the test, which detected 39 mutations, was cleared by the FDA in September 2009 (www.clinica.co.uk, 4 September 2009). It has also developed a test which can identify 71 cystic fibrosis-causing mutations, xTAG Cystic Fibrosis 71 Kit v2, which was CE marked for sale in Europe in 2009, and cleared by Health Canada this year.

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