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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Apr 14, 2011

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Cepheid said this week that it has received clearance from the US Food and Drug Administration to market its Xpert C. difficile/Epi test.

Cepheid's first Xpert C. difficile test, which only detects C. difficile, has been available in the US since July 2009. The newly approved test additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1, or BI, Cepheid said.

"Compared to less-virulent strains, C. difficile 027 strains produce higher levels of spores, which pose greater infection control challenges," Cepheid CEO John Bishop said in a statement. Bishop also noted that there is a growing body of evidence that the 027 strain is associated with more frequent relapses and ultimately higher mortality rates.

The Xpert C. difficile/Epi test, which runs on the GeneXpert system, is Cepheid's tenth Xpert test to receive FDA clearance. It is expected to be available for shipment in mid-May, the company said.

The Scan

And For Adolescents

The US Food and Drug Administration has authorized the Pfizer-BioNTech SARS-CoV-2 vaccine for children between the ages of 12 and 15 years old.

Also of Concern to WHO

The Wall Street Journal reports that the World Health Organization has classified the SARS-CoV-2 variant B.1.617 as a "variant of concern."

Test for Them All

The New York Times reports on the development of combined tests for SARS-CoV-2 and other viruses like influenza.

PNAS Papers on Oral Microbiome Evolution, Snake Toxins, Transcription Factor Binding

In PNAS this week: evolution of oral microbiomes among hominids, comparative genomic analysis of snake toxins, and more.