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Amnis Eyes Sequencing, SNPs, Hematology As It Stays the Course with Cellular Analysis

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Seattle-based Amnis, which in December launched its flagship Image Stream 100 imaging flow cytometer, is now considering a wide variety of diagnostic and genomics applications for the instrument with an eye toward building out-licensing alliances and R&D partnerships.

However, in the short-term the company plans to maintain its focus on basic cellular analysis, according to an Amnis executive.

The new strategy is taking shape just a few months after former CEO Jack Ball resigned, and after chief technology officer and company co-founder David Basiji was tapped to replace him (see CBA News, 5/2/2005).

At the time, Ball told CBA News that he and other company executives differed on the best way to move Amnis forward, illustrating that Amnis wanted a "more low-key approach to commercialization" of the Image Stream.



"We're in this frustrating position — as one can be when you've got a platform technology — where there are a lot of directions you can point it, but you just have to point it there."

Although neither Ball nor Amnis provided much more detail beyond that, it seemed as if Ball wanted to focus essentially all of the company's resources on landing Image Stream customers at core flow cytometry facilities for basic cell analysis applications, and eventually tackling the drug-screening market.

Now, Amnis will continue to pursue the applications for which the Image Stream was first targeted, but it also appears that the company wants to explore a variety of other options.

"We're in this frustrating position — as one can be when you've got a platform technology — where there are a lot of directions you can point it, but you just have to point it there," Basiji told CBA News last week.

First, Amnis plans to continue developing the Image Stream for its core applications. The company recently secured half of a planned $6 million Series C financing round from a "consortium of a dozen new private investors," including Amnis' existing investors.

According to a statement, Amnis plans to use the proceeds "to expand commercial operations and accelerate key clinical application and product development programs already in progress." Last week, Basiji provided additional details about what the funds are earmarked for.

Next on the company's list is to look for ways to pay for new applications. "The money we've closed on so far is primarily for sales and marketing and commercialization efforts for the current product," Basiji told CBA News, "while the money we get above this level is really going to accelerate two projects."

The first, Basiji explained, is the development of a cell-sorter based on the basic ImageStream technology. "We're going after the flow cytometry market, and once there is a cell-sorting Image Stream, there is essentially nothing that a flow cytometer can do that we can't."

Although Basiji did not want to offer a firm schedule for the introduction of such an instrument, he said the company is targeting a timeline of two to three years.

The second new area, Basiji said, is hematology. "The hematology market is facing a crunch right now, because the automated analyzers can analyze normal samples … but if they get too [abnormal] … the analyzers kick those samples out [so] a human being has to look at them," Basiji said. "The problem is that most of the humans that are looking at these blood smears are nearing retirement age, and it's thought that by 2010, they're only going to have about half as many of these cyto-technologists to read blood smears as needed."

The difference that Image Stream might bring to the table is its ability to image cells in suspension which, according to Basiji, makes the instrument "an absolute no-brainer to apply to blood analyses."

Genomics Applications

Another area that Amnis is considering is adapting the Image Stream to bead-based applications such as SNP detection, sequencing, and antibody-ligand interactions — basically research areas for which Luminex has been marketing its bead technology.

Last week, Amnis won US Patent No. 6,934,408, "Method and apparatus for reading reporter-labeled beads," (see Patent Watch, this issue) which, though it refers in its abstract to DNA hybridization applications, covers essentially any type of assay where multiplexed beads could be detected and imaged in flow on the Image Stream, Basiji said.



"I would characterize the [latest patent] as IP we'd be willing to license and want to work with somebody on, and it's not something we're working diligently on right now."

"This IP is geared toward really any kind of multiplexed assay, including sequencing by hybridization, SNP analysis, or if you wanted to do cytokine analysis, by putting different antibodies on every bead, and you needed libraries that were bigger than your typical Luminex-style library," Basiji said.

"If you remove the constraint of the size of the bead library from the problem — if you're not limited to 50-bead signatures — all of a sudden your ability to perform different applications with what are essentially fluid arrays goes way up," he added. "Now you can talk about sequencing by hybridization with beads, doing a SNP analysis of an entire genome in one shot, and even being able to pool different samples and doing SNP analyses of a lot of different individuals' genomes in a single run."

Seeking Partners

As Amnis begins exploring these other niches, it realizes that it probably won't be able to go it alone. Basiji said that it would like to be in the position to take the new application areas forward on its own, "but then there is reality. We're just getting the resources to get the company on its feet and profitable with our current platform, and with the next-generation platform."

For instance, even though Basiji believes Amnis can "make a really big splash" in the hematology arena, he said that the company "will not be going head to head against the Beckman Coulters and Abbotts of the world.

"I think that for clinical apps, our strategy is going to be to develop those through feasibility stage, and then partner up with a larger clinical partner to get the applications developed to the point where they're robust, get them through the FDA, and [develop] any dedicated instrumentation that needs to go with them," he said.

The same holds true for the highly competitive sequencing and SNP-analysis market, Basiji added.

"I would love to be in a position to have some experts in bead technology working on this for us in-house, but the fact of the matter is that we've said to ourselves that we will probably do this with a partner," Basiji said. "I would characterize the [latest patent] as IP we'd be willing to license and want to work with somebody on, and it's not something we're working diligently on right now. Right now it's just sort of IP in our pocket"

— Ben Butkus ([email protected])

 

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