Cepheid

Alere received FDA 510(k) clearances for four tests, including those for influenza A and B, strep A, and RNA-based respiratory syncytial virus.

In Life Sciences, CEO Thomas Joyce noted a strong performance by Beckman Coulter, while in Diagnostics, he said Cepheid grew 25 percent year over year. 

The new instrument has higher throughput than competing systems, while the flu test boasts enhanced sensitivity and protection against seasonal drift.

The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.

The company said that EPS for next year is anticipated to be between $3.50 and $3.60. On an adjusted basis, EPS is expected in the range of $4.25 to $4.35. 

The firm beat the consensus Wall Street estimates on the top and bottom lines as the diagnostics segment saw revenues grow 20 percent year over year. 

The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month. 

The automated real-time PCR test provides results in as little as 18 minutes.

The Ultra's combination of a lower limit of detection and ability to find dead bacilli after starting TB therapy vastly improves sensitivity compared to other tests, the study’s authors said.

The study is the first to demonstrate the design features and operational characteristics of Cepheid's Xpert MTB/RIF Ultra assay.

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