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CE mark

The kits can detect more than 1,000 antimicrobial resistance gene variants, including mobilized colistin resistance (mcr) and extended-spectrum beta lactamases.  

The firm said that it has received 288,000 requests for quotations for the test since it was made available for preorder on Feb. 14.

The microarray runs on the company's CE marked Mosaiq system for blood grouping and transfusion-transmitted infection screening.

The South Korean company has now received CE marking for its hepatitis B, hepatitis C, and HIV-1 detection kits, which run on its ExiStation system.

The molecular assay detects and differentiates Trichomonas vaginalis and/or Mycoplasma genitalium in clinical urine samples.

IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.

The firm also has an early-access program for a new amplification strategy that combines 11 HLA genes for typing.

CE marking of PromarkerD Hub complements the CE mark that the mass spectrometry version of the test received in November.

The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.

The CE mark advances the firm's strategy to develop and commercialize two- to five-minute tests that use fingerprick blood or stool samples, ProciseDx said.

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