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Applied Microarrays CEO Discusses Future Of Codelink, Including Tapping New Markets

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Name: Alastair Malcolm
 
Title: President and CEO, Applied Microarrays
 
Background: Before founding Applied Microarrays, Alastair Malcolm served as vice president of molecular diagnostics operations at GE Healthcare. He previously held positions as vice president of life science operations and vice president of global operations at Motorola. Malcolm holds a BSc in physics from the University of Glasgow.
 

 
BARCELONA, Spain — For the first five months of 2007, the future of the Codelink bioarray platform looked bleak. GE Healthcare said it planned to shutter the business and sell off its assets, and had pledged to help customers adopt other platforms.
 
But a last-minute deal with Applied Microarrays that April secured the future of the platform (see BAN 12/19/2006, BAN 5/8/2007).
 
AMI paid an undisclosed price for the entire GE Codelink catalogue except the slides and reagents. Now, a year later, AMI is increasingly finding that Codelink’s production capability — rather than the whole-genome human, mouse, and rat arrays that largely defined the bioarray platform under previous owners — is driving the firm’s business.
 
According to CEO and President Alastair Malcolm, AMI is trying to take advantage of Codelink technical capabilities developed and improved under GE Healthcare and previous owners Amersham and Motorola, to reach markets that those owners never addressed.
 
Malcolm spoke with BioArray News at Select Biosciences’ Advances in Microarray Technology conference, held here last week.
 
The last time we spoke, you were in the process of setting up a distribution network for the Codelink product line.
 
That’s right. We set up a network of 17 distribution agreements around the world and initially focused them on Codelink sales. Now we are taking the distributors into the next phase. We are having them find leads for our custom array business.
 
So they are now bringing custom projects to your lab?
 
Our main business, the way it has evolved or the strategic direction we took our business in … is as an OEM partner for custom microarrays. What we have seen, and what some of the presenters at this conference have shown, is that there has just been an explosion in the types of biomarkers that have become available. It’s gone way beyond gene expression and genotyping.
 
We are building on the foundations that we have had at Motorola, Amersham, and GE, to use our business systems which support traceability and efficient, close-loop-bound manufacturing; and also taking advantage of our ISO 9001 and ISO 13485 conformances. We’re using all of that foundation and the technical platforms that were developed but never launched under Amersham and GE. They had developed miRNA platforms, antibody platforms, peptide platforms, but never launched them as products.
 
Now Applied Microarrays is taking customer sets who are really developing biomarker panels but don’t want to go to the capital expense, the ongoing expense of running their own microarray facility, and are coming to us to do in some cases some development, but in most cases their industrial-scale manufacturing of these custom arrays.
 
That was always our strategic intention and after 12 months in business now, that really is 80 percent of our business.
 
How is the Codelink side developing?
 
Codelink is going well. We are introducing new formats through collaborations with companies like BioMicro Systems where we can put two genomes onto a glass slide. It might actually be the best value array. We are offering two genomes on a slide for human, mouse, and rat, though we are looking at some other animal and plant species as well. We are selling these to core facilities for [about] $80 in the US and €50 in Europe.
 
So it really becomes a very attractive proposition for core labs that are doing genome research because rather than selling it as an open system where you are on your own to do your own assay, we are characterizing our products with multiple sets of reagents, multiple instruments — including the hybridization instruments and various scanners, to get the quality and reproducibility of a closed system, like the leaders in the gene expression market, which also gives them the opportunity to run their own internally developed panels of markers on the same platform.
 
So Codelink is very much still alive. There is an economical solution and we have made it more open with more equipment options.
 
Are you going to announce partnerships with these external companies or do you prefer to keep it more open?
 
We prefer to keep it more open. There are a number of companies that we are working with, and in the past Codelink, for example, was exclusively on SurModics surface and exclusively for use with Ambion reagent kits and we had specified particular scanners. We have really tried to open that up so that if a particular customer already has a [BioMicro] MAUI System in their lab, we will make sure that the protocols and the reagents allow them to use the instrumentation [if] they have got an array like Codelink that has already been through the [Microarray Quality Control project] and people know that they can compare the data with the leading platforms out there.
 
Codelink is still very much alive, but it is not the main focus of our business. We are probably in a better position in that there are other contract manufacturing companies out there for microarrays, but they have got different foundations from us. They in some sense have tried to go up the value chain from being equipment tool suppliers to getting into some contract spotting activities. In some cases they have been more like core labs that have more capacity than necessary for their own universities or institutions.
 
We have come at this obviously from a very different background. We have designed and developed microarrays and assays, protocols, instruments, et cetera. We have done that at an industrial scale under the quality system that a company like GE enforces. That is becoming, we believe, a very attractive partnership model.
 
There is a plethora of new companies right now that are identifying various biomarkers but don’t want to set up a microarray facility internally. So that’s or business.
 
I remember I spoke with AMI last year about some specific new content arrays that were in development, for example, a women’s health chip.
 
Yeah, we killed them. We killed them really for a couple of reasons. Whenever you try to produce a panel that looks at a particular [disease-specific] pathway, immediately you produce the panel — which may have been created from literature, research, and some other things — [but] it’s almost obsolete by the time you get around to printing it. The customers will always want some additional markers that they have discovered.
 
Also, in a sense, because we are an OEM partner for people who may well be developing something like a cardiac array or some other cancer-specific [array], we don’t want to compete, if you like, with our customers. We want to support their custom array for a disease or a pathway and allow them to take that to market. We will be the expert spotting company that supports them.
 
There were a number of labs and companies that were offering Codelink as a service when it was owned by GE. Do you still supply them with chips?
 
Yes, we do. And by offering two genomes on a chip at an attractive price, [we are trying to] reengage with core labs that maybe switched as part of the GE announcement to exit Codelink and get them to come back to Codelink and use it as an open system going forward. So we are still made available in many core labs around the world.
 
What are your main priorities for the company now that it has been set up with a new strategy and you have these distribution agreements in place?
 
The main priority really is creating high-volume partnerships for custom OEM manufacturing. We are focusing on the lower-density arrays. We are not going to go down the path of the multi-million feature arrays. We believe that the growth areas are going to be in having the flexibility to run microscope slides, microtiter plates, [and] special substrates on silicon and other materials for all of the new classes of biomarkers. Most of these tend to be in the lower-density level. I mean less than a few thousand features on an array. And that is where we have got excellent capabilities for design, manufacture, high quality, high throughput, et cetera
 
So our main focus is to support the partners that we have in the pipeline, and help them grow going forward.

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