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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

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.

Survey Sees Genetic Literacy on the Rise, Though Further Education Needed

Survey participants appear to have higher genetic familiarity, knowledge, and skills compared to 2013, though 'room for improvement' remains, an AJHG paper finds.

Study Reveals Molecular, Clinical Features in Colorectal Cancer Cases Involving Multiple Primary Tumors

Researchers compare mismatch repair, microsatellite instability, and tumor mutation burden patterns in synchronous multiple- or single primary colorectal cancers.

FarGen Phase One Sequences Exomes of Nearly 500 From Faroe Islands

The analysis in the European Journal of Human Genetics finds few rare variants and limited geographic structure among Faroese individuals.