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.
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.
The London School of Hygiene and Tropical Medicine's Sharon Peacock argued a sequencing-based pathogen surveillance approach could uncover outbreaks faster.
Google's Project Nightingale has collected health information on millions of Americans, according to the Wall Street Journal.
Nature News writes that women in chemistry are less likely to have their manuscripts accepted for publication.
An opinion piece at The Hill criticizes the proposed plan to collect DNA samples from migrants at the US border.
In PNAS this week: tRNA fragment signature for chronic lymphocytic leukemia, genomic sites sensitive to ultraviolet radiation in melanocytes, and more.