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Caliper Sees Sample Prep, Thermo Cycling Technologies as Key to Molecular Dx Strategy

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Caliper Life Sciences expects molecular diagnostics to make a much greater contribution to its revenues over the next five years, and believes that its sample-preparation patents will be key to those efforts.
The company also said it expects its on-chip thermal cycling technology to be a welcome addition to certain next-generation sequencing companies, particularly those that use single-molecule or rare-molecule sequencing.
Speaking this week at the Biotechnology Industry Organization’s CEO and Investor Conference in New York, Caliper CEO and President Kevin Hrusovsky highlighted molecular diagnostics as the “next frontier of opportunity” for the company. The firm’s efforts in that area will be based on its LabChip platform and incorporate patented sample-prep and workflow technologies that have yet to be commercialized.
Hrusovsky told conference attendees that it was not the firm’s goal to develop content for the LabChip, but rather enable partners to develop their own assays on the system. He also said that he believes molecular diagnostics, from which Caliper currently derives a sliver of revenue from partner Agilent, will account for 20 percent to 30 percent of its revenue by 2012. 
“The core technologies that we’re utilizing to achieve this are already being deployed in some other commercial offerings,” Hrusovsky told BioCommerce Week in a follow-up interview. “However, integrating workflows into these microfluidic chips is always a specialized thing with each one of these collaborators.
“In only one case do I actually see it being commercial in the next 12 months,” he said. “The rest of them are more like two to three years away.”
Hrusovsky said one of the key enablers of the firm’s LabChip platform for molecular diagnostics is a thermal cycling technology that can be incorporated into individual chips. He noted that the patented technology is outside the scope of patents held by Applied Biosystems and Roche, which have sued — and settled with — many rivals selling PCR thermal cyclers.
There isn’t a single patent that covers both the workflow integration and PCR thermal cycling in a microfluidic chip, but he said the firm holds a license to a broad patent issued to the University of Pennsylvania covering DNA amplification on a microfluidic chip.
Agilent, under a molecular diagnostics collaboration signed with Caliper in 2005, expects its assay for HDL-LDL cholesterol to receive FDA approval later this year, said Hrusovsky. That approval would mark the first commercialization of that sample prep technology, though he said that Agilent already uses the technology in a home-brew test.
“They’ve licensed our patent estate in order to take microfluidics into diagnostics,” said Hrusovsky, adding that Agilent had for several years previous held licenses to Caliper’s technology for research applications.
He also noted that Agilent’s 2100 Bioanalyzer platform, which is being used in a collaboration announced this week with Lipomics, is essentially Caliper’s platform (see Briefs).
Next-Gen Sequencing Play?
In addition to molecular diagnostics, Hrusovsky said that Caliper’s thermal cycling technology would be ideal for use with many of the new next-generation sequencers, which he said face a bottleneck in the sample prep stage. He mentioned Helicos and 454 Life Sciences as firms whose sequencing instruments would benefit from using Caliper’s sample-prep technology.
Hrusovsky said the firm is in early-stage discussions with next-gen sequencing firms, but he did not specify which ones. “We feel there is tremendous potential for us to integrate workflows, and do sample preparation for single-molecule sequencing or rare-molecule sequencing,” he told BioCommerce Week. “There is no current development deal in place, like there is in diagnostics.”
Hrusovsky also said that there are some other companies that provide content for genotyping studies that have told him that they believe Caliper’s technology can provide some sequencing capability.

“Integrating workflows into these microfluidic chips is always a specialized thing with each one of these collaborators. In only one case do I actually see it being commercial in the next 12 months.”

“So, it’s not just the sample-prep integration,” he said. “We think that inside of our chips we’ll be able to achieve some of the sequencing, [and] that could be a big complement to some of these other newer generation of sequencing” platforms.
Though Hrusovsky made his comments about the molecular diagnostics and next-gen sequencing markets at the end of his presentation, the majority of his talk at the conference focused on Caliper’s in vitro-in vivo bridge, which is the combination of its traditional LabChip business with the small animal molecular imaging technology the firm gained through last year’s acquisition of Xenogen.
He pointed out that several of the world’s largest pharmaceutical firms — among them Novartis, Sanofi-Aventis, AstraZeneca, Pfizer, Merck, Johnson & Johnson, and Amgen — are using this so-called I-I Bridge in their preclinical drug research programs. “This is a very core area of our current strategic success with these companies that are utilizing this for … [analyzing] the kinome and the proteome,” said Hrusovsky.
Caliper recently combined its NovaScreen Biosciences and Xenogen Biosciences arms into a single drug-discovery service division called Caliper Discovery Alliances and Services, or CDAS.
The new service division will put Caliper in more direct competition with contract drug-discovery operations such as MDS Pharma Services, though CDAS’ portfolio of in vitro and in vivo assay services may be largely unmatched in the industry.
Specifically, CDAS offers more than 700 in vitro assay types, including receptor, enzyme, and ion channel screening and profiling, side-effect, and ADME-tox panels, as well as cellular models for immunology, oncology, and other fields. It also offers more than 85 in vivo pharmacological assays that measure more than 400 parameters for applications such as compound profiling and phenotyping, and target validation.

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