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As HCS Strategy Begins to Take Hold, CompuCyte Warily Revisits Clinical Apps

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Having re-established its laser scanning cytometry technology as a tool for high-content screening in drug discovery and functional genomics, Cambridge, Mass.-based CompuCyte may soon be sniffing around the clinical diagnostic marketplace again.

However, for now the company continues to try and build revenue in the drug discovery and basic research markets through sales of its LSC-based platforms, Elena Holden, CompuCyte's president and CEO, told CBA News last week.

The clinical diagnostics space is territory that CompuCyte once penetrated and subsequently retreated from. The company, which has been in existence since 1994 and has offered its LSC technology since 1996, announced in April 2002 that it was restructuring its operations to focus fully on its LSC-based platforms, which have since resurfaced as the company's "i" series imaging cytometers.

As part of the restructuring, CompuCyte jettisoned a cell-based clinical analyzer it called OnCyte, which at the time was still in development. In August, it introduced the iCyte automated imaging cytometer, the first of three future "i" series instruments that it said were improved versions of the company's original laser scanning cytometry technology. In 2003, CompuCyte launched its iCys research imaging cytometer, which combined the LSC technology with even more microscope-based imaging capabilities.

It is unclear exactly what caused the company to shy away from the clinical arena, or whether it was seeking FDA approval for its technology. However, at the time Holden said in a statement that "the OnCyte program had reached a major developmental milestone at the time of the market downturn. Placing the program on hold and concentrating on the LSC allows us to take full advantage of new trends in research and drug discovery that have enhanced the value of laser scanning cytometry technology."

The "new trend" that Holden spoke about was the rapid uptake of high-content screening technology into drug discovery for secondary screening and assay development application — for which the LSC technology was designed.

Most so-called high-content screening instrument platforms on the market are based on automated microscopy, in which a CCD camera actually takes fluorescent images of cells on a plate or in flow. These generally use confocal, confocal-like, or basic fluorescence microscopy.

A few platforms, such as TTP Labtech's Acumen Explorer, use a combination of PMT's and multiple laser excitations to capture high-content data from cells with higher throughput, but without generating actual images.

CompuCyte believes that its customers can have their cake and eat it, too.

"At the very beginning of our venture, we entertained [the] idea that you need to provide the cytometric component, and that the imaging component will not be as important," Holden said. "But we were very naïve and young in our development. You realize that you need to provide the best of both worlds — not just accurate enumeration, but also very good imaging components, so you can provide very high spatial resolution, and can enable enumeration studies or translocation studies. So the combination of both is very important," she said.

The LSC technology performs this little trick by raster-scanning a solid sample with up to three lasers, collecting fluorescence data with PMTs, and then using image-processing software to reconstruct a virtual image based on the data points. The iCyte is essentially based on this concept alone, while the iCys has a full fluorescence microscope function added to the mix. Both instruments, according to Holden, are designed primarily for secondary screening, assay development, and toxicology screening.

And like TTP Labtech's instrument, the iCyte and iCys have been validated for use with translocation-type assays — such as Molecular Devices' Transfluor — which typically demand actual images of fluorescently tagged proteins in cells (see related story, this issue).

Holden said that CompuCyte's instruments also find use in cell-cycle analysis, antibody-based assays, and assays based on fluorescence resonance energy transfer.

Although CompuCyte declined to provide specific sales figures, and hasn't officially announced the names of customers for its "i" Series instruments, Holden said that its pharmaceutical partners include Amgen, Pfizer, Novartis, and GlaxoSmithKline; while its academic partners include the Mayo Clinic, MD Anderson Cancer Center, and Case Western Reserve University. She added that the platforms retail in the $300,000 to $400,000 range, depending on the inclusion of specific software and automation features.

Back to the Clinic

Now, however, CompuCyte is again slowly approaching the clinical diagnostic market, starting with the introduction late last year of its iColor fluorochromatic imaging cytometer, which Holden said is specific for tissue analysis applications.

In addition, last month the company inked an agreement with Asterand in which that company will be offering tissue analysis services to its pharmaceutical and biotech customers.

Although Asterand is not in the clinical diagnostics market either, it offers a type of tissue-based analysis for basic research that could easily be translated to a clinical setting.

CompuCyte said that this service will be based on whichever of CompuCyte's "i" series platforms would be most appropriate. However, CompuCyte has not yet begun to ship the iColor platform to any customers, and expects to do so by the end of this quarter, Holden said.

"The combination of green, red, and blue lasers allows the visualization of chromatic dyes in the same manner as pathologists would see the tissue," she said. "So that color match is very important for that particular market segment — clinical research and pathology labs.

"Our instruments are not FDA approved, and therefore we do not target, at least for now, the clinical diagnostic market space," she added. "But we are very actively involved in drug safety validations of the platforms."

Holden said that FDA approval of its technology for diagnostic applications is "perhaps a next step that we will be considering.

"The platform is certainly FDA approvable, and it would make great sense to do so," she added. "We've validated a number of ideas, such as quantitative analysis of HER-2 in immunohistochemistry samples, as well as other interesting and relevant clinical studies. However, that development would require additional partnerships and funding, because it's a long-term program." It was not immediately clear whether or when the company would file the technology with the agency.

Consequently, diagnostic applications are still a distant goal for CompuCyte.

On the financial front, CompuCyte said it will eschew any additional financing in the near future. It last raised VC when it restructured in 2002. Holden said the company currently relies on "instrument sales and application development work, which we do in large quantities" to generate revenues.

"Our near-term plans are the complete introduction of the [iColor], and we are also working on adding functionality to our existing platforms," Holden said. "I'm not at liberty to discuss what's going to be the next release, but it will happen within the next two or three months … and it's going to be an exciting addition to the functional abilities. Also, we'll be increasing the software functionality, and thinking about the next generation of LSC technology."

— BB