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SpeeDx Mycoplasma Genitalium Kit Listed With FDA

NEW YORK (GenomeWeb) – The US Food and Drug Administration has listed SpeeDx's ResistancePlus MG Positive Control kit for sale in the US, the company said today.

The kit will be sold through SpeeDx's recently incorporated US entity. The Australian parent firm has also been registered with the FDA as a medical device manufacturing establishment. Clinical trials in the US for ResistancePlus MG remain on track, it said.

The kit contains synthetic DNA to simulate Mycoplasma genitalium and five mutations that are known to confer resistance to macrolide antibiotics. The assay received CE marking in 2016.

The Scan

Call for a Different Tack

Experts weigh the value of recent experiments testing genetically modified pig kidneys using brain-dead individuals, according to Nature News.

Wastewater Warning

The New York Times reports that wastewater surveillance in some parts of the US point to a possible surge.

Can't Get in the Program

Due to the Northern Ireland protocol dispute, the European Union is preventing UK researchers from joining the Horizon Europe research program, the Times of London reports.

Science Paper on Spatial-Controlled Genome Editing

In Science this week: approach to enable a CRISPR-Cas13a-based system to be used as a cancer therapy.