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Molecular flu tests cleared, 5/17

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May 2017—Cepheid received FDA clearance to market Xpert Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as 20 minutes. The tests are Cepheid’s first Xpress branded products, which are expected to deliver results in 30 minutes or less.

Xpert Xpress Flu and Xpert Xpress Flu/RSV are twice as fast as their pred­ecessor, Xpert Flu/RSV XC, but have comparable performance characteristics. The new tests feature and share a novel design, which employs multiple targets for each virus. The built-in redundancy results in both high sensitivity and specificity and reduces the impact of seasonal genomic drift in these viruses, which has historically been a problem with molecular tests.

Cepheid, 408-541-4191

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