Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential merits for reducing antimocrobial resistance of speeding up regulatory approval for new urinary tract infection point-of-care diagnostics such as Lodestar DX and UTRiPLEX.

The speed of regulatory approval is reliant on the device manufacturer's ability to submit required documentation for registration with the Medicines and Healthcare products Regulatory Agency (MHRA), which includes evidence that it conforms to United Kingdom legal requirements as described by the UK Medical Devices Regulations. The MHRA will check the documentation and revert with a registration letter that enables the point-of-care diagnostic devices to be placed on the market in the UK. Manufacturers of innovative products can also seek advice from the MHRA through its Innovation Accelerator.

NICE has published an article describing the potential merits for reducing antimicrobial resistance with four innovative tests for diagnosing urinary tract infections which include Lodestar Dx and UTRiPLEX.