MediWales has reported that Public Health Wales has developed a novel assay to improve the diagnosis and treatment of invasive disease.

The Microbiology Division of Public Health Wales is pioneering new molecular and genomic technologies and has developed a groundbreaking assay which has the potential to reduce pharmacy costs for a specific condition, as well as enable more prudent usage of clinical follow up resources through a highly specific and unique methodology.

The assay has been incorporated into a diagnostic and therapeutic fever care pathway, where a proof of concept study showed the pathway to be a safe way to exclude disease when both tests were consistently negative. Consequently, in the first six months expenditure was reduced by approximately £125,000, and more than offset the cost of testing. The utility of the strategy was further confirmed by a clinical audit of the service over five years of testing where high sensitivity (98.1%) and negative predictive value (99.3%) allowed clinicians to withhold unnecessary therapy in consistently negative patients. This resulted in a year on year reduction in expenditure compared to the start of the audit and this trend has continued to date.

By combining a commercially developed amplification assay with a set of clinical recommendations, a fully standardised molecular approach is attainable. While a few commercial assays are now available they lack in depth clinical evaluation and most have only limited participation in European clinical testing efforts. Furthermore, the Public Health Wales assay has extensive clinical evaluation using a range of specimen types providing assay robustness and utility.

Public Health Wales are now seeking to develop a partnership with a relevant industry partner to scope and develop the commercialisation of these novel diagnostic tests and services. This would develop the necessary arrangements to commercialise this novel test and service which could take a number of forms, from the manufacture and branding of a new product through to service provision.

Expressions of interest are invited from relevant industry partners to collaborate with us in regard to the commercialisation of these novel diagnostic tests and services. Partners will be expected to set out, at a high level, their views on the approach that will need to be taken in order to do this.

A shortlisting process will then be undertaken by a multi-disciplinary panel which will include Welsh Government, Public Health Wales and independent industry advisers, with successful organisations being invited to participate in the development of formal proposals.

Following submission of non-disclosure agreements, participating organisations will receive briefing information and a request to develop a proposal for Public Health Wales to consider. Public Health Wales will provide details to enable comprehensive proposals to be developed and submitted.

Following presentation of proposals and subsequent evaluation, Public Health Wales will appoint the partner submitting the most commercially relevant bid.