In the months leading up to Caliper Technologies’ acquisition of Zymark last July, Caliper had spent some $25 million to learn whether it could apply its LabChip microfluidics platform to molecular diagnostics.
The theory was simple enough: Marry the LabChip platform with sample preparation and molecule detection and you could substantially reduce reagent outlays — a major cost center in pharmacogenomics labs — while enabling researchers to observe mutations that would have been invisible using traditional microtiter plates.
Seven months later, Caliper, which had since changed its name to Caliper Life Sciences, has decided to put the theory into practice by hunting for R&D collaborations with biomarker content and primary chemistry players, according to Kevin Hrusovsky, Caliper’s new CEO.
The former Zymark chief said he plans to bet as much as $20 million more to validate the concept and introduce it into the $1.2 billion molecular diagnostics marketplace that comprises analyte-specific reagents and in vitro diagnostics.
“Molecular diagnostics is an important new area for Caliper,” Hrusovsky told investors during a presentation at the Piper Jaffray health-care conference in New York City last week. It is “the newest focus” for the company.
Caliper calls its new business unit Rare Molecule Detection. In essence, Hrusovsky said, Caliper researchers have found a way to put a metal lead inside a channel in its microfluidic-based LabChips. The scientists were able to alternate temperature down the lead and perform PCR in-line, enabling gene mutations to be amplified in a very small volume.
In a later interview with SNPtech Pharmacogenomics Reporter’s sister publication GenomeWeb News, Hrusovsky said the platform uses the principle of digital PCR: “Let’s take this well and make 1,000 of it to increase the concentration of the mutated cell, and to find the rare molecule that indicates” disease, Hrusovsky said.
“By doing so, you can see mutations that you can’t see in normal microtiter plates because concentrations are just too low,” he added. “When you run [a sample] through a chip, you [also] can have tremendous savings in reagent consumption costs.”
Hrusovsky told SNPtech Pharmacogenomics Reporter this week that a “prototypical molecular diagnostic test” using Caliper’s platform can, in theory, reduce reagent use by between 1,000 and 2,000 times, and confer a five- to 10-fold reduction in staff. “These are the kinds of economics that we get excited about.”
While Caliper said it would ultimately try to apply its technology to detecting mutations in human blood, the company to date has only focused on identifying mutations in stool samples.
He said during the Piper Jaffray presentation that Caliper officials are now “talking to biomarker content players and primary chemistry players to see if we can get some underwriting to further develop these technologies, which we think this can transform our company to the next level.” He added that his staff has shopped the idea to two of what he claims to be 20 potential collaborators that exist worldwide.
Caliper is also hoping to ink deals with drug makers, especially Roche and Abbott — Roche because of its diagnostic chops and Abbott because an in-law of Hrusovsky’s, Irene Hrusovsky, is the widow of Edward Ledder, a former chairman of Abbott Labs. Irene Hrusovsky is CEO of Eragen, which markets the GeneCode sample-quantitation and genotyping technology.
He said one possible application would be to link up with a liquid-handling company or a SNP-detection company to develop an ASR or IVD that can be sold to clinical laboratories. “What we have now are data [that the platform can work],” he said. “But finding a content provider to put [samples] in our chips for reference labs would be one market area that would be attractive to us.”
Hrusovsky, who said he expects to have a system commercialized in one or two years, has also enlisted the help of molecular diagnostics consultant Jorge Leon, a former Quest Diagnostics official.
To Caliper, the molecular diagnostics space is worth around $1.2 billion. And while it is a fraction of the market in which the company’s two core businesses participate — Discovery and Development sells to a $2.7 billion market while Genomics and Proteomics plays in an $8.3 billion space — molecular diagnostics is growing at a 20-percent clip; the Discovery and Development and Genomics and Proteomics markets grow around 9 percent each year, said Hrusovsky.
“Anything that’s going at that pace is attractive,” he said.