Biofortuna appointed as CMO for QuantuMDx CE–marked assay

Biofortuna has provided assay development and manufacturing support to QuantuMDx Group Limited to assist in the manufacturing scale-up, regulatory approval and launch of their rapid, sensitive SARS-CoV-2 test.

The QuantuMDx assay is a real-time, reverse transcriptase PCR test for laboratory use that has been developed using advanced bioinformatics to maximise performance and delivers results in approximately 70 minutes.

The reagents are lyophilised in a single tube, making the assay more convenient than liquid-based kits, resulting in a longer shelf life and no requirement for cold chain shipping.

Biofortuna, working closely with the team at QuantuMDx, scaled up initial production to 2 million tests per week with the potential to deliver up to 3 million tests per week.

The QuantuMDx SARS-CoV-2 assay has been CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within the European Union.

QuantuMDx has registered the test with the UK’s Medicine & Healthcare Products Regulatory Agency and applied to the US Food and Drug Administration for Emergency Use Authorisation.

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