These selections of forward-looking quotes are highlights of the year from the Lab Report series, a set of interviews of newsmakers, leaders, and technicians – workers at all levels of the microarray industry.
Gary Hardiman, Director, Biogem (Biomedical Genomics Microarray Facility), and Assistant Professor, Department of Medicine, University of California, San Diego (Feb. 2000-Present) (see BAN 12/10/2003)
“The business model was originally for these [microarray core] facilities to be stand-alone and self-sufficient, and that the arrays would be an inexpensive alternative to commercial products. That model is flawed now because it is difficult to compete with arrays made in commercial environments with stringent quality controls. There has been a lot of evolution over the last three years, the technology has gotten much better, and off-the-shelf arrays have gotten competitively priced, while making good microarrays is quite challenging. The technology has changed — the facility has changed as time has gone by.
. . . The whole concept of having facilities as a stand-alone business is not going to survive. But these facilities are a vital resource in any university — they contain the equipment and the individuals who can get the information to those that want it – and there is value in that. Core facilities will become more specialized research centers rather than the standalone facilities that you find now.”
Amit Kumar — President and CEO, CombiMatrix (see BAN 11/12/2003).
“The bottom line is that these [microarray-based] tests are going to be regulated by the FDA, just like any other test. As such, the decision they made on the [Roche] AmpliChip was that if physicians are going to use this, they are going to regulate it. Period. That is to be ex-pected. It does make the hurdle for getting into the market a little bit bigger, because now you have to go through 510(k) approval, but certainly that hurdle is not as big as you have to go through in developing a therapeutic. I’m positively predisposed to it. It provides more credibility to this whole opportunity."
Manisha Desai, Assistant Professor, Biostatistics, Mailman School of Public Health, Columbia University (see BAN 10/29/2003).
“[Microarray technology is] really permeating everywhere. I know of a periodontist here interested in looking at differences in gene expression between people who have a more advanced stage of the disease versus not. And, I have a collaborator who is looking at differences in gene expression between left vs. right hypertrophy in children with congenital heart disease. So it’s really beginning to appear in almost every clinical field.”
Doug Amorese, R&D Manager, Agilent Technologies, Bio-Research Solutions Unit (see BAN 10/22/2003)
“The large improvement in the scanner that we tackled last year was more of an issue of the feature extraction software. People love the software, the automation and scanning and feature extraction, but the home-brew array users had to feature-extract using another package. The new version of our software has a feature extractor that allows users to process arrays made by home brew. That has been well received.”
Stanley Rose, President, CEO, NimbleGen Systems (see BAN 10/15/2003)
“There is no doubt a great increase in the utilization of [microarray] services. Throughout biology, there is a matter of getting cost effectiveness in spending R&D dollars. Rather than build capabilities, rather than buying equipment and training people to run those, and becoming experts in analysis, why not work with a core lab, or an external reference lab or a core group, that can provide the answer? The key there is to convince people that you do quality work, that they can trust the data. In biology, there is an inherent desire to hold on to samples. Everybody likes to do things themselves if they can. You have to balance that against the costs involved in building on-site. I don’t mean to say that I think that there is going to be a decline in people purchasing systems on their own, I just think the market is expanding in a number of directions. The companies that rely on placing new systems will continue to grow at reasonable rates. The emergence of a more service-oriented market is above and beyond that.”
Margaret Cam, Director, Microarray Core Facility NIDDK, NIH (see BAN 10/1/2003)
“We pay for the products. If we can’t get first-hand what the real data is out of microarrays, what difference does it make? These are not unreasonable demands that we are making. We are only asking to interpret our data with more ease and accuracy than we have in the past. Scientists in general don’t have the necessary funds to run even more replicates — like the statisticians are asking for — in this state of affairs with such little reproducibility and problems comparing across platforms. It’s such a minefield to wade through.
Alvis Brazma, Microarray Informatics Team Leader at the European Bioinformatics Institute (see BAN 9/17/2003)
“I think the first step in understanding what different quantitation in one platform means in terms of the others — that will come pretty soon. I know that there are some initiatives to get these major manufacturers together and come to some agreement. It may also happen in [at an upcoming meeting], if we have some enough time. This agreeing on some standard protocols and controls, that probably will take a little more time.”
Greg Heath, Senior Vice President of Clinical Genomics of Roche Molecular Diagnostics (see BAN 9/10/2003)
“If you have, for example, 500 mutations, you are probably pretty sick. You probably don’t need a microarray to tell you that.”
Peter Hotten, Director of Licensing and Business Development, Oxford Gene Technology IP (see BAN 8/13/2003)
“You can’t just create an IP portfolio. It has to generate an income. You have to protect your ground, and talk to those who need your advice. We have some good relationships with our licensees; they recognize the importance of our IP being kept strong.”
Chung-Cheng Liu, Deputy General Director, Biomedical Engineering Center, and Director, Molecular and Biomedical Technology, ITRI, Taiwan (1999-Present) (see BAN 8/6/2003)
“We think the clinical use of microarrays represent[s] the great future for array products and the uses will increase as the quality and cost of the arrays continue to improve.”
Trevor Hawkins, vice president development, Discovery Systems, Amersham Biosciences (see BAN 7/30/2003)
“The question might best be: What shouldn’t be on a chip? We will move to a plan where every and any genome can be on a chip. There are questions on gene expression that you want to ask on every genome — mammalian, microbial, you name it. . . . [Any] genome done today will be on a chip. . . . We are just now getting to the point where making custom bioarrays that are highly specific, in perhaps more numbers, is not only technically feasible, but is also going to make business sense.”
Dick Svrluga, Boston Angel Investor (see BAN 7/23/2003)
“It has been a difficult and challenging time the last couple of years. Personally, I sense a loosening in the last few months. The companies I’ve been involved in have closed [on], or have come close to closing on financing, all within the last three months. I’m sensing a little bit of a shift. Some of the money I see coming in is from [individual] investors, not the blue-chip investor funds. Valuations today are quite good — and if you have the resources in hand, now is a good time to invest.”
Michael McNeely, Founder and Chief Technical Officer, BioMicro Systems (see BAN 6/11/2003)
“In Singapore, microarrays are pretty mature: You have the Genome Institute, with a lot of high-tech savvy researchers that are so competent and so on top of things. Conversely, other places are just starting to understand the value of microarrays. There is not a great user community in other parts of Asia, but that will be changing soon. In Taiwan, they are looking for new markets and new areas for manufacturing. Korea is interested in high-end applications while China is interested in the low-end.
Donna Storton, Technical Staff, Princeton Microarray Core Lab, Synthesizing and Sequencing Facility, Molecular Biology Department, Princeton University. (see BAN 5/16/2003)
“[What is needed is] standardization instrument-to-instrument, and program-to-program. But, that is not going to happen, otherwise people wouldn’t make any money.”
Peter Tolias, Vice President, Advanced Research and New Technology Worldwide, Ortho-Clinical Diagnostics (see BAN 5/9/2003)
“Protein arrays and mass spec in screening biological fluids are really the first step in biomarker discovery. The dynamic range in serum and body fluid is 10 to the 10th power, and we have looked at 4 logs at the top. But that is not where all the action is. We lack sensitivity and need another leap in advanced fractionation to get to the low end.”
Alison Elizabeth Murray, Assistant Research Professor, Division of Earth and Ecosystem Science, Desert Research Institute, Reno, Nev. (see BAN 1/31/2003)
“Labeling technology has to improve. Highly sensitive labeling technologies are needed for microarrays to work in the environment.We can't always get 10 micrograms of RNA from a sample. . . . That's a lot.”