The US National Institute of Standards and Technology is in the process of writing a proposal for a multi-year, multi-million dollar program to enhance the reliability of products and services that are based on gene-expression technologies.
The multidisciplinary team creating the proposal is seeking input on the economic impact that such a potential program could bring.
The team has three questions it would like answered by interested members of the industry:
1) What are the reliability-related problems in gene-expression tools that:
- measurement science and /or bioinformatics might address as well as
- the reduction or elimination of which would significantly expand the market for products and services based on gene-expression technologies?
2) What are the potential benefits to users of gene-expression technologies (in terms of higher-quality and/or lower-cost products and services) if these reliability-related problems were reduced or eliminated?
3) What is the estimated impact (in terms of increased industry revenues) if the benefits in (2) are achieved?
Readers of BioArray News can respond directly to Robert Fireovid, program manager, NIST at [email protected].
NIST is a non-regulatory agency of the US Department of Commerce’s Technology Administration. The agency develops and promotes measurement, standards and technology designed to enhance productivity, facilitate trade and improve the quality of life.
The agency is already involved in helping to create technical standards for microarrays. The NIST working group on RNA is considering proposals for two RNA standards, one for within laboratories, and another external standard. The internal standard would be a pool of standard sequences agreed on by all commercial array manufacturers that would also be available to home-brew users. It would provide an internal measure of the quality of any array experiment with respect to sensitivity, dynamic range, and specificity. The external standard would be a complex pool of highly characterized RNA targets to be used as an external reference for any RT-PCR or array-based method.
For scanners, NIST would develop an “artifact” — a microarray slide — to standardize measurements of uniformity and signal to noise; and measure a scanner’s limits of detection. It would also identify appropriate fluorescent materials based on Cy3 and Cy5 dyes. A committee, which comprises a dozen scanner manufacturers including Affymetrix, Agilent, Axon, PerkinElmer, BioRad, Arrayit, and others, has created a set of specifi-cations for a standard microarray slide that would be coated uniformly and include two instruments — one created for the middle of the dynamic range, and one for very dim signals. Glass flatness would not exceed plus or minus 10 microns, on a preferred substrate of glass. The slides would be 1x3 inches and fitted to other users who do not follow that format. The microarray/scanner fluorescence standards group is expected to select a fluorescent material for the artifact from a choice of organic photo stable fluorescent dyes, silica doped with metal oxides, or quantum dots/nanocrystals.