As Invitrogen prepares to launch a microRNA microarray platform, the company will take aim at an emerging market that has recently garnered quite a bit of attention from rivals in the BCW Index.
During the past two months, Applied Biosystems and GE Healthcare both announced their entries into the miRNA field — a niche market with a variety of potential applications but whose size has not been reliably established. While those two firms are selling their miRNA products for use on their respective instruments, Invitrogen, which will not offer instrumentation, will also likely face growing competition from miRNA reagent plays.
Invitrogen's NCode miRNA microarray platform, which will be launched next month, consists of a miRNA isolation product, a labeling and detection system, an array for profiling microRNA-expression patterns, and some controls. According to the firm, the platform will enable researchers to profile all known and predicted miRNAs from humans, as well as mouse, rat, Drosophila, C. elegans, and zebrafish miRNAs.
"Any folks interested in gene regulation are now taking a look at microRNAs. It's made them completely rethink the field. And the other area that we're seeing a lot of interest in is clinical research, [with] people looking at cancer, or disease subclassification that traditionally had been done with standard messenger RNA microarrays. They're actually now looking at microRNAs and finding that they're getting even tighter correlation and more informative data."
According to Peter Jozsi, Invitrogen's manager for NCode, the pre-printed array will be printed in duplicate. It will contain about 330 human microRNAs, with an additional 150 or so human predicted microRNAs — those that have yet to be validated. There also will be 250 mouse, 200 rat, 93 Drosophila, 130 C. elegans, and 163 zebrafish miRNAs, with controls spotted throughout. He said customers will be able to order it as an array or split it into probe sets if they want to print arrays themselves.
Though research on microRNAs has been going on for at least a couple of decades, it remains a nascent field with potential applications in identifying biomarkers for cancer, stem cell research, and developmental biology.
Stem cell and tumor research, in particular, have become areas in which miRNA analysis is becoming more commonplace. "Any folks interested in gene regulation are now taking a look at microRNAs," Criss Walworth, ABI's product director for TaqMan Gene Expression, told BioCommerce Week in September (see BioCommerce Week 9/15/2005).
"It's made them completely rethink the field. And the other area that we're seeing a lot of interest in is clinical research, [with] people looking at cancer, or disease subclassification that traditionally had been done with standard messenger RNA microarrays. They're actually now looking at microRNAs and finding that they're getting even tighter correlation and more informative data," she said.
"Pharma has certainly taken an interest [in miRNAs], and some groups within the industrial community are looking at patient stratification order and subtyping tumors," Invitrogen's Jozsi said. "The interesting thing about microRNAs is that they are implicated in so many types of diseases that it's really ranging from the basic research level all the way through to pharma."
He also said that the miRNAs fit in with Invitrogen's plans for developing biomarkers for the molecular diagnostics market. "We are already evaluating and have some interesting results in-house using these arrays to profile stem cells," he said.
He told BioCommerce Week that the NCode arrays are sold in packs of five for $750 dollars, which equates to roughly $700 for 20 reactions. He said there are "a lot of developmental biologists that are looking at microRNA expression profiles with different times and points throughout larval differentiation or stem cell differentiation. And, so we wanted to provide a product that performed well but was also affordable."
Sizing Up the Competition
ABI is selling its miRNA assays at a cost of $3,990 for a set of 157 human assays, which equates to just over $1 per reaction, according to ABI's Walworth. She also noted that ABI is offering a promotional price for the assays — which run on any of ABI's real-time PCR instruments — in connection with the launch.
"Pharma has certainly taken an interest [in miRNAs], and some groups within the industrial community are looking at patient stratification order and subtyping tumors. The interesting thing about microRNAs is that they are implicated in so many types of diseases that it's really ranging from the basic research level all the way through to pharma."
Meanwhile, GE has not announced pricing details yet for its miRNA arrays.
Though none of the firms that have begun, or plan to begin, selling miRNA arrays have provided a market-size estimate, Jozsi said, "If you were to compare it to the current array market, like expression profiling for mRNA, it's certainly a fraction of that. We've seen an explosion over the last few years in the number of publications for microRNAs.
"So it's an extremely hot field right now … [and] we project there will be really strong growth in the next few years," he added.
Backing up Jozsi's assertion, a search this week on PubMed returned 612 papers mentioning microRNA since 2001. A little less than half of those papers have been published during the past 11 months.
In addition to ABI and GE Healthcare, which inked a deal with Ambion last month to develop miRNA microarrays on the CodeLink platform (see BioCommerce Week 10/6/2005), a number of firms have already begun offering or have said they will eventually offer miRNA arrays or reagents, including Stratagene, Qiagen, Exiqon, GenoSensor, and Third Wave.
Unlike some of these competitors, Invitrogen is not offering instrumentation with its arrays and has not signed any alliances with instrument manufacturers, though such partnerships may not be far down the road. Invitrogen is "actively pursuing applications-oriented co-marketing relationships with companies that have instrumentation facilitating miRNA analysis," Jozsi told BioCommerce Week.
He also noted that it wasn't necessary to have the high-density capabilities offered by some of the current microarray manufacturers, such as Affymetrix, Agilent, ABI, and GE Healthcare, in analyzing miRNAs. He said the NCode platform can be run on a standard two-color scanner, such as those sold by Axon or PerkinElmer.
"High-density arrays are great for a number of genomic applications, but in this instance, it looks to be not that necessary to profile these with a high-density array," Jozsi said. "At this point we are pursuing novel content as best we can through collaborations [with] industrial as well as academic groups. We hope to increase our content and thus the value of the array through that route."
— Edward Winnick ([email protected])