The requirement and range of markets for nucleic acid measurement technologies continues to grow, and researchers and instrument manufacturers are responding appropriately. With the development of sophisticated sequencing and amplification techniques, molecular biology has been transformed and new areas of research opened up. The change has been dramatic: ten years ago, sequencing a short fragment of DNA was a labour-intensive and time-consuming piece of work. Now it is an automated task completed in a matter of hours.
This accessibility and the ease with which DNA measurement can now be carried out have resulted in an expansion of established applications, covering pharmaceutical and clinical screening, forensic science, and the detection of pathogenic agents, with many others under development. This, combined with the increasing competitiveness of business, has resulted in the need for continually improving technology. For example, in the pharmaceutical industry, the time and monetary costs of developing a new drug have reached such levels that the technology currently in use is operating close to its limit of performance, and that the new genomics-based approaches will require new capabilities. Forensic science has made use of DNA fingerprinting methods for almost two decades, and its success has prompted a wish among police forces and government bodies to improve and extend its availability to new areas such as scene-of-crime DNA analysis, wildlife crime and relationship testing. There are many other potential application areas, and there is thus a growing market for integrated measurement systems which can do the job more quickly, efficiently and cost-effectively.
This VAM project aims to provide a mechanism for technology developers to assess their products in terms of measurement performance and ability to meet regulatory requirements for particular market sectors, enabling them to:
- target appropriate end-points and partnerships in product development;
- validate their products against appropriate market and regulatory requirements;
- ensure fitness for purpose at the point of exploitation.
A previous report detailing current nucleic acid measurement technology produced for this project1 showed that:
- There is significant early-mid development phase commercial activity in integrated DNA devices, but few examples of such systems are currently on the market.
- Current developments can be subdivided between sensors, integrated laboratory-on a-chip systems and miniature devices produced by more conventional engineering approaches. The resulting systems have their relative merits and characteristic performance criteria
- Early commercial devices are mostly only part integrated, taking the input through more than one step in the measurement cycle, but rarely providing the means to move completely from sample to result without pre or post transfers or processing.
This report presents the results of a market and regulatory study carried out in support of the project objectives.
References
1. Integrated nucleic acid measurement technologies, VAM report LGC/VAM/2002/023 (2002)