As the major players in the microarray industry and a healthy number of startups gathered for IBC Life Sciences’ annual Chips to Hits conference in Boston this September, the field’s entry into the diagnostics market promised a rosy future for microarray technology.
The conference featured talks about the current state of the microarray industry, strategies on entering the market and protecting intellectual property, and future growth potential. Most notably, protein arrays, tissue arrays, biomarkers, microfluidics, and the future use of microarray technology in clinical and point-of-care diagnostics all featured prominently in presentations throughout the conference.
However, there were a couple of conspicuous absences. Perhaps most perplexing was the lack of discussion regarding standards and the regulatory picture for the use of microarrays in diagnostic applications. Several presentations pointed to clinical and point-of-care diagnostic uses as potentially huge markets for microarray technologies, yet virtually no one discussed the US Food and Drug Administration’s current thinking on the subject.
With the recent European approval of Affymetrix’s GeneChip System 3000Dx and Roche’s CYP450 AmpliChip, the issue of how the FDA intends to regulate such products has taken on greater urgency. The agency is working with a number of firms on developing requirements, but it has yet to publish a guidance document seeking comments on potential regulations.
According to Andy Brooks, director of the American Medicine Development Company’s Microarray Resource Center, “People are at least thinking about the applications, so now it makes sense to start turning the crank.”
— Ed Winnick
US Patent No. 6,797,393. Method for making biochip substrate. Inventors: Tiecheng Qiao, Krishnan Chari, Thomas Penner, Zhihao Yang. Assignee: Eastman Kodak. Issued: September 28, 2004.
The patent describes a gelatin-based substrate for fabricating protein arrays, in which the substrate contains gelatin and a trifunctional compound A--L--B; wherein A is a functional group capable of interacting with the gelatin; L is a linking group capable of interacting with A and with B; and B is a functional group capable of interacting with a protein capture agent. A may be the same or different from B.
US Patent No. 6,794,658. Light modulated microarray reader and methods relating thereto. Inventors: Calum MacAulay, Pierre Lane. Assignee: Digital Optical Imaging. Issued: September 21, 2004.
The patent describes microarray readers and methods that compensate for target spots that are too dim or too bright for a typical microarray reader to accurately measure. The readers covered under the patent adjust the amount of light directed at or received from specific non-acceptable target spots, such that dim spots receive more excitation light and overly bright spots receive less. This effectively increases the range over which a microarray reader can accurately measure the spots, and can also improve the signal-to-noise ratio.
The cost of Telechem’s 10 µm microarray scanner set to be released in the fourth quarter — the first seven-color 10 µm scanner with a list price of less than $20,000.
TIGR and Affymetrix are close to finishing a 500,000-spot gene chip containing more than 3,400 SNPs that may help scientists identify differences in closely related strains of Bacillus anthracis, the bacterium responsible for anthrax.
The Broad Institute of MIT and Harvard will use high-throughput microarray technology from Affymetrix in three studies involving RNA expression analysis, SNP genotyping, and DNA resequencing.
Schott Nexterion opens a new production facility in the town of Jena in Eastern Germany designed to make Schott’s production capabilities more efficient as it prepares to take over the manufacturing of Acceler8’s OptArray microarray slides.
DNA Chip Research forms a DNA chip product distribution pact with Mitsui and NovusGene. NovusGene will market DNA Chip Research’s proprietary products, including the AceGene series, and also accept orders for DNA analysis services.
ExonHit Therapeutics licenses its microarray-based toxicity evaluation system, Safe-Hit, to Mitsubishi Pharma. The microarray is based on RNA splicing events specific to toxicity.
NIAID awards Perlegen Sciences a $566,090 grant to use its oligo-nucleotide array-based genotyping platform to conduct a whole-genome association study designed to find the genetic determinants of Alzheimer’s disease.