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Agilent Sees Strong Demand in miRNA Line As it Prepares Follow-On Product Launches

Agilent Technologies sees sizeable demand for its new miRNA arrays and is preparing several phases of related product launches and capability expansion in hopes of attracting more customers for an application that the firm is betting will be as lucrative as its array comparative genomic hybridization line, according to the firm’s miRNA product manager.
Mike Caren told BioArray News during a site visit to Agilent headquarters last month that “uptake has been beyond expectations” for the miRNA array product line and that the firm quickly met its quarterly sales goal following the launch of its Human 1.0 miRNA microarray in April (see BAN 4/10/2007).
To help ensure that the platform continues growing in the market, Agilent now plans to offer rat and mouse miRNA chips this fall, followed by a kit for working with formalin-fixed, paraffin-embedded samples and custom array capabilities that will be offered through the firm’s eArray web portal. Both the FFPE kit and the custom array options will become available in early 2008, Caren said.
In a follow-up e-mail this week, Caren wrote that there is “strong demand” for the arrays “coming from both pharmaceutical and academic accounts.” According to Caren, there are two main drivers for the growth: Agilent’s assay and the nature of the market.
“Our assay has the sensitivity, specificity, and comprehensiveness that the market needed to start running large-scale studies,” he wrote.
But beyond the selling points of its assay, Caren wrote that there is a larger trend at work — the desire among both academic and industrial researchers to stake out intellectual property rights in a nascent field where new miRNAs are still being discovered.
“A lot of the major papers, intellectual property, and biology of miRNAs are going to be established in the next couple years,” Caren explained. “For an academic, a lot of significant miRNA biology is going to take place because it is now possible to economically measure all known miRNAs,” he wrote. “This will drive the research, major findings and papers in the field,” he added. 
For the industrial researcher, the IP around miRNAs as prognostic markers, classifiers, and drug targets is still up for grabs, he noted. “Securing these [patents] is of high importance to many companies — therefore, there is a strong driver to be first and get the best possible position.”
Among the commercial research segment, cancer is a clear driver for miRNA array adoption. Exiqon, a Danish biotech that sells the miRcury miRNA array product line, sees enough potential in the area that it has developed its own internal diagnostics program to capitalize on any cancer-related biomarkers that come out of its miRNA research.
“The scientific literature has documented a strong link between miRNA expression profiling and the development of cancer, metabolic disorders, neural disorders, as well as the differentiation of stem cells,” Exiqon CEO Lars Kongsbak wrote in an e-mail to BioArray News two weeks ago. “Exiqon has been focusing on cancer” (see BAN 6/26/2007).
“MiRNAs have been shown to play a key role in cancer — the impacts appear to be very broad,” Caren noted this week. 
Phases II and III
In order to cultivate a receptive market for miRNA arrays, where several firms, including Exiqon, Invitrogen, Febit, and Asuragen now play, Agilent must establish itself as the “gold standard by which researchers profile miRNAs,” Caren wrote this week. Part of that strategy is product proliferation.

“A lot of the major papers, intellectual property, and biology of miRNAs are going to be established in the next couple years.”

The first phase of new miRNA array products to roll out of Agilent’s lab in Santa Clara will be miRNA arrays for mouse and rat, due sometime this fall. An updated human catalog array design is also expected. Caren wrote that Agilent is now also “considering” developing a labeling kit and an early-access program for custom miRNA arrays.
Agilent currently offers a proprietary dye conjugated pCp to end label the miRNA. Currently it must be bought separately. Agilent’s new kit would enable users to “buy a warranted assay level solution [of] array and reagents from a single source,” Caren wrote.
Following the launch of the mouse and rat arrays, two additional improvements are planned for “phase III” of Agilent’s miRNA product deployment.
According to Caren, Agilent will begin offering custom miRNA arrays for all organisms through its eArray web portal sometime next year.
A kit for FFPE samples will also become available in 2008. “The main driver is for performing prospective studies on archived samples,” Caren wrote.
“The primary challenge is to be able to effectively and consistently label the miRNA across a variety of tissue types in different stages of degradation. We feel our simple direct labeling protocol will be well suited for this challenge,” he wrote.
Looking ahead, Caren wrote that Agilent is optimistic about its ability to dominate the miRNA array market and in the potential of miRNA “ to serve as diagnostics, prognostics, and drug targets.”
“We feel confident in both, and that is why we are investing so heavily in building a comprehensive miRNA profiling solution,” he wrote.

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