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Amnis Hopes December Launch of Cell Analysis Platform Will Spur Profitability

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Amnis’ ImageStream 100 microscope-cum-flow cytometer will be the newest platform for high-throughput cell-based assays when it hits the market in just a few weeks, marking the company’s official entry into the cellular analysis marketplace.

The Seattle-based biotech startup is hoping that ImageStream sales will start it down the path of profitability. Jack Ball, Amnis’ president and CEO, told Inside Bioassays last week that Amnis believes that worldwide there are approximately 3,400 flow cytometry and imaging core facilities laboratories that would find benefit from ImageStream, and another 12,000 non-core facilities where it would be useful.

Realistically, Ball said that the company believes it can eventually place 7,000 to 8,000 instruments worldwide. At a current list price of $250,000, that adds up to a $2 billion dollar revenue potential.

Two weeks ago, Amnis said in a statement that the ImageStream would be commercially available in December. It also revealed the identities of early-access customers spanning academia, government, and industry that had completed beta-testing of the product. Those customers include the Fred Hutchinson Cancer Research Center, the National Institute of Allergy and Infectious Disease, and Cell Therapeutics. Amnis had previously publicized a partnership with the Coriell Institute for Medical Research.

Last week, Ball provided additional details, telling Inside Bioassays that Amnis is planning a “bi-coastal” launch of the product: Dec. 4-8 at the American Society for Cell Biology annual meeting in Washington, DC, and Dec. 4-7 at the American Society of Hematology annual meeting in San Diego.

The company’s presence at both conferences speaks volumes about the ImageStream’s potential applications, which Amnis has maintained will span basic cell biology research, drug discovery, oncology, and diagnostics.

It also provides a clue as to who Amnis’ major competitors will likely be, as BD Biosciences and Becton Dickinson are the only other instrument providers that are slated to exhibit at both meetings. Although each of these companies has recently acquired technology for high-content plate-based cellular analysis, Amnis hopes the ImageStream — which combines fluorescence microscopy with flow cytometery — will provide an alternative for applications that are traditionally run on those companies’ flow cytometry platforms.

One of those applications is detection and characterization of specific cell populations in fluid, a use that is of particular interest to hematologists. David Moscatello, an assistant professor and supervisor of the Differentiated Cell Laboratory at the Coriell Institute, told Inside Bioassays that the ImageStream compares favorably to alternative methods for such applications. Specifically, the lab is characterizing stem cells from umbilical cord blood.

“We actually have a couple of diverse applications for it, but this is the first thing we’ve been using it for,” Moscatello said. “We’re investigating whether or not it might be useful as an adjunct to fluorescence-activated cell sorting, which is the standard technique for looking at the percentage of CD34+ cells in a population,” a test that is crucial for determining transplant compatibility, he said.

“One of the reasons we’re interested is that we can actually visualize the cells themselves; so we’re not just looking for fluorescence events, but can correlate the fluorescence with cell morphology,” he added.

This capability provides several advantages over FACS, he said, including the ability to distinguish separate cells that might be contributing to a single fluorescence signal, and using nuclear morphologies to differentiate similar cell types.

“It also is relatively easy to use, and with the new software … it will get even easier,” Moscatello said. “I know my postdoc, who’s been doing the bulk of this work, has found it certainly easier than the FACS.”

Moscatello said the group presented data on this comparison at the inaugural Stem Cell Institute of New Jersey conference held on Nov. 11, and that it plans to submit the data for publication once it is complete.

The DCL is also using the ImageStream to help produce differentiated cell cultures and cultures of adult tissue-derived stem cells, and to facilitate verification of EBV-mediated genetic transformation of rare mammalian cell types.

Drug Discovery

All this is not to say that the ImageStream won’t also be useful in drug discovery; however, it may not be suitable for traditional drug- screening applications.

“It can certainly be used for drug discovery, especially if your target cells happen to be hematopoetic cells of some sort,” Moscatello said. “If you wanted to look at apoptosis or activation of certain cell-signaling pathways, you could certainly do that.

“Amnis has already established that it’s quite useful for looking at apoptosis as compared to necrosis, for example, and they’ve also shown that one can look at NFKB translocation,” he added. “Although you’d have to run each sample individually, so it wouldn’t be something that you would screen 10,000 different treatments with, but more for looking at a mechanism.”

Ball said that Amnis actually has “gotten the most traction” overall from nuclear translocation applications, because the ImageStream can determine the degree of translocation of “each and every cell.”

One criticism of the platform as a high-content drug discovery tool, however, is that because it is still based on flow, it only takes a snapshot of each cell — regardless of how many there are — making kinetic assays of living cells difficult.

Ball responded by saying “in our studies and in talking with high-throughput screeners, 90 percent of them use fixed cells. So what difference does it make, if it’s fixed, whether you look at it once, twice, or a thousand times?”

Despite the company’s excitement about the pending launch of its flagship technology, Amnis continues to struggle towards profitability.

In June, Ball told Inside Bioassays that the company had just initiated a series C financing round that it expected to net about $12 million by the end of July (see Inside Bioassays, 6/1/2004).

However, last week Ball conceded that the company was not able to meet the July target, and that it was still attempting to raise necessary funds.

“It’s been difficult to get the investors to rally behind an instrument platform, but we’ve gotten strong support through our existing investors TVM, Orbimed [Capital], and [Emerging Technology Partners] during that time,” Ball said. “We’ve now got a clear path to profitability in 2006, and both I and our current investors are confident that we’ll close the round very shortly. It’s not been quite as fast as I would have liked, but we’re still making progress.”

The good news for Amnis is that it sold “the bulk of the [ImageStream] units at the full list price,” Ball said, adding that this “is unusual with beta units, which are usually discounted by about 50 percent.”

Ball said feedback from the early-access users has served primarily to refine the software usability by automating many of the parameters that users once were responsible for controlling. “I think this is probably the biggest thing you’ll see going forward,” Ball said. “We’ll plan periodic software releases. We just did one in October, we’ll do another in early January, and we’ll do a cycle about every six months.”

Another refinement the company is currently investigating is how the ImageStream might be made compatible with an emerging labeling technology — quantum dots.

“We’ve got four fluorescent channels that we detect simultaneously,” Ball said. “And we’re working with one of the nanocrystal companies right now — I don’t want to say who — to develop crystals that are absolutely dead-center in each of our four channels, which would mean no overlap and no cross talk, and minimal need for compensation.”

And Ball maintains that interest in the product remains high. Two weeks ago, the company sent out an e-mail to people on the company’s product update listserv, describing how the ImageStream could be used for “molecular tracking of monoclonals, moving into cells, into early endosomes, and then lysosomes,” Ball said.

“We had over 40 percent of people that received that e-mail visit our website over the next day and a half,” he said. “That just shows the level of interest that a platform like this can create.”

— BB

 

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