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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.
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.
Collaborators said that the test is accurate and reliable for the rapid detection of the most common gram-positive bacteria responsible for bloodstream infections.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
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