Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make it his policy to ensure that any point-of-care diagnostic tests for urinary tract infections approved by NICE are made available to women in (a) rural, (b) deprived and (c) other areas.

Answered by Will Quince

NHS England and the Anti Microbial Resistance Programme is working to support the development and deployment of point-of-care diagnostic tests approved by National Institute for Health and Care Excellence for urinary tract infection (UTI) diagnosis, and education on the use of these tests will form a key part of ensuring equitable accesses to women, including in rural and deprived areas.

NHS England are also working with industry partners, charities, pathology and clinicians to understand the clinical need for new point of care diagnostics as this will help ensure the future pipeline of UTI diagnostics are fit-for-need.

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.

Answered by Will Quince

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.