8th September 2017

Public Health Wales Microbiology Call for Industry Partnerships

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.

As such, we 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.

There will be 3 phases in the development of this innovation partnership:

Phase 1: Expressions of Interest

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 muti-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.

Expressions of interest should be emailed to: PHWCOMMERCIAL@wales.nhs.uk together with whatever supporting material you feel is necessary. Please ensure that “Expression of Interest: Microbiology” is clearly in the subject field when sending. THE DEADLINE FOR SUBMITTING EXPRESSIONS OF INTEREST IS 13th OCTOBER 2017.

Phase 2: Development of 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.

Phase 3: Award and implementation

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

Supplementary information

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

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 6 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 PHW assay has extensive clinical evaluation using a range of specimen types providing assay robustness and utility.

In summary, as a result of the continued optimal performance in analytical studies and the proven clinical validity and utility there is an interest in commercialising the service to offer it to a wider customer base and/or a commercial version of the PHW assay.

For anymore information please get in touch with Tom James at Welsh Government