Of particular interest is the use of nucleic acid measurement techniques, since they provide a means of specifically identifying the source or nature of biological material, are robust, and can be applied across many industrial sectors. Indeed, the range of different tests which are possible has resulted in their widespread adoption for pharmaceutical, forensic, food, environmental, defence and other applications; and the need for suitable technologies is growing.

Integration and miniaturisation are seen as key attributes, and much development work has been carried out over the last two decades, resulting in the commercialisation of some innovative ideas. Somewhat less advanced, however, are the means by which 'fitness for purpose' of a particular technology solution for a particular market application can be assessed. There is now a need for a set of validation criteria which can be used to assist the technology development process and ensure 'fitness for purpose' at market launch – meaning that all performance, cost and regulatory requirements are met by the new product.

The aim of this project is to provide such a validation framework by examining the relationship between the performance characteristics of new technology for DNA and RNA measurement and the requirements of the market sectors for which it is intended.

This framework will provide UK companies with a means of validating their products

or end user applications against those available or under development by assessing them against factors such as measurement performance, operational requirements, cost and compliance with any regulatory framework which may be in force.

This report describes the first stage of the process: a thorough review of the current state of the art in terms of technology both under development and on the market. Although the focus of the project is on UK-based companies, this work required a worldwide perspective as a large proportion of relevant technology is being developed abroad, and companies are increasingly global in their outlook. The principal means used were:

• reviews of the literature and company web sites;
• reviews of intellectual property, primarily via the US and European Patent Offices;
• contact with technology developers and end users;

The information gathered was stored in a matrix format for cross-comparison and transfer to a database, and for subsequent use in the framework. The market and

regulatory study is reported separately, as are the specific details of the framework's construction and operation.

The results show that properly integrated systems are much less prevalent than originally perceived, and that the integration of the many separate technology elements that fit together to make a complete process remains the most challenging obstacle to date. It was also clear that intellectual property issues dominate in this field, with US companies holding many fundamental patents and a complex dispute environment.

Conversely, work in the UK tends to be centred around specific niche areas, except where the basic intellectual property is held here. The pharmaceutical research sector is particularly strong in the UK, and is where many of the applications are targeted.

Two technologies – the DNA microarray and the polymerase chain reaction – have established themselves to the greatest extent in commercial terms. The former is an example of a novel approach with the potential to revolutionise genetic screening and drug discovery; while the latter has its roots in the 1980s, but has only recently become a properly portable and easy-to-use technique. However, the range of products close to market launch is large, and the rapid expansion already observed is set to continue over the next few years.