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FDA Says Cepheid's MRSA Dx Is Of 'Moderate Complexity'

NEW YORK (GenomeWeb News) — The US Food and Drug Administration has determined that Cepheid’s methicillin-resistant Staphylococcus aureus test is of “moderate complexity” under its Clinical Laboratory Improvement Amendments guidelines, the company said today.
 
Cepheid said that the categorization will enable the Xpert MRSA test to be used both within and outside traditional hospital labs.
 
The FDA in April approved the test, which is designed to rapidly detect MRSA, a common cause of nosocomial infections.
 
The test runs on the company’s GeneXpert system, which combines sample prep with real-time PCR amplification and detection functions, the company said.

The Scan

Just Breathing

A new analysis suggests that most Mycobacterium tuberculosis is spread by aerosols from breathing, rather than by coughing, the New York Times reports.

Just Like This One

NPR reports that the World Health Organization has hired a South African biotech company to recreate mRNA vaccine for SARS-CoV-2 that is similar to the one developed by Moderna.

Slow Start

The Wall Street Journal reports that Biogen's Alzheimer's disease treatment had revenues for July through September that totaled $300,000.

Genome Research Papers on Cancer Chromatin, Splicing in the Thymus, Circular RNAs in Cancer

In Genome Research this week: analysis of bivalent chromatin sites, RBFOX splicing factors' role in thymic epithelial cells, and more.