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The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said.
Working with Amazon and Illumina software tools, startup ICBiome has built a platform to help hospitals spot clusters of pathogens early.
A longitudinal household study suggests patients can acquire methicillin-resistant or sensitive Staphylococcus aureus from household members, pets, and surfaces.
The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
Exome sequencing and other molecular strategies led to a heterogeneous variant in the DNMT3A gene that appears to impact host epigenetic and immune features.
Based in Warsaw, Poland, the technology was inspired by "ultra-fast" PCR methods from the Wittwer group and Scope plans to launch tests for MRSA and C. diff.
The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.
The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.
An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
When researchers sequenced some 800 global Staphylococcus aureus isolates, they saw signs of previous jumps from humans to domestic animals and beyond.
Politico notes that the Biden Administration has not yet nominated a permanent Food and Drug Administration commissioner.
Anthony Fauci also informed the World Health Organization executive board that the US would be joining the COVAX initiative, according to CNBC.
A new preprint suggests some SARS-CoV-2 variants could affect the effectiveness of current vaccines, the Associated Press reports.
In Nature this week: Australian lungfish provides details on the movement of vertebrate life from water to land, and more.