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Aiming to Carve Out a Share of a Niche Market, ABI Rolls Out miRNA Assays

Applied Biosystems last week launched its TaqMan microRNA assays, thrusting the firm into an emerging niche market that has yet to establish a dominant player.

ABI is banking on its broad market reach, reputation of TaqMan, and currently installed instrument base to establish a presence in the microRNA market. In addition, the firm should be able to take advantage of its collaboration with noted genetics and microRNA researcher Victor Ambros of Dartmouth University to raise its profile among researchers in the field.

Criss Walworth, product director for TaqMan Gene Expression, told BioCommerce Week that a key selling point would be TaqMan's high level of specificity and dynamic range compared with other gene expression quantification methods — which she said is important because microRNAs are very short sequences, but they have a wide range of expression.

The new assays can run on any of ABI's real-time PCR instruments, according to Kathleen Shelton, senior product manager for the miRNA assays. ABI's RT-PCR systems product line includes four real-time PCR instruments systems that use TaqMan chemistry — the Prism 7900HT Sequence Detection System; the Prism 7000 Sequence Detection System; the 7300 Real-Time PCR System; and the 7500 Real-Time PCR System. The company began marketing the 7300 and 7500 systems during its 2004 fiscal year.

The firm will sell the assays at a cost of $3,990 for a set of 157 human assays, which equates to just over $1 per reaction, according to Walworth. She noted that ABI is offering a promotional price for the assays in connection with the launch.

"Any folks interested
in gene regulation are
now taking a look at microRNAs. It's made
them completely rethink
the field."

ABI's entry into the miRNA market fits in with earlier suggestions by its management that the firm would seek more sales opportunities in consumables. "We have an incredible strength in capital equipment sales," Carl Hull, vice president and general manager for ABI's RT-PCR and gene-expression business lines, told investors visiting the company's Foster City, Calif., headquarters on April 5. "Our real opportunity is to take that core competence and build a shell around it. Consumables represent a big opportunity for us and we are focused on that" (see BioCommerce Week 4/14/2005).

Though research on microRNAs has been going on for at least a couple of decades, it is a nascent field with potential applications in identifying biomarkers for cancer, stem cell research, and developmental biology, according to Shelton.

"Any folks interested in gene regulation are now taking a look at microRNAs," added Walworth. "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 told BioCommerce Week.

Dartmouth's Ambros has been working with ABI researchers on the expression of microRNAs in human tumors and presented the results of some of that research at this year's European Society of Human Genetics annual meeting. In an interview with BioCommerce Week sister publication RNAi News, Ambros said, "The [ABI] assay is very sensitive, so that allows us to use small samples, and sample size is limited when one is using biopsies from humans. Secondly, it is very quantitative and reproducible, so the data is going to be really robust — we feel we'll be generating a data set that will have a long legacy in the scientific community [and] will be useful for a long time" (see RNAi News 5/20/2005).

Comments like these and ABI's established presence in the genetic research field could give the firm an advantage over a variety of smaller players that have launched miRNA assays or are employing their technologies in collaboration with miRNA researchers.

The Competition

Among the firms with which ABI stands to compete in the miRNA assay field is US Genomics, which recently launched its Direct miRNA assays. In addition to the assays, the firm launched a fee-for-service program last month that allows researchers to submit RNA samples to the firm for analysis on its Trilogy 2020 Single Molecule Analyzer.

Potential competition also could come from Luminex, whose bead-based flow cytometric platform was used by Todd Golub and collaborators at the Broad Institute, MIT, the Dana-Farber Cancer Institute, and St. Jude's Children's Research Hospital to measure the expression of miRNAs in a variety of cancers. Though Golub used Luminex's platform, he has not disclosed which firms he has held discussions with regarding his miRNA profiling approach, saying only that there has been considerable commercial interest in his miRNA work (see RNAi News 6/17/2005).

Other competitors could include RNAi firm Ambion, which received a $265,000 grant earlier this year from the National Institute of General Medicine Sciences to develop analytical tools for microRNA function, and this week announced that it would adapt its platform to detect, quantify, and characterize proprietary microRNA sequences discovered by Rosetta Genomics; Mirus Bio, which also received a grant from NIGMS earlier this year to develop methods for efficient labeling of microRNA for microarray analysis; Genaco Biomedical Products, which is using Exiqon's nucleic acid technology to develop a bead-based array system for detection and classification of microRNAs; Third Wave Technologies, which has said its Invader platform is capable of enabling miRNA applications; and GenoSensor, which markets the GenoExplorer miRNA biochip.

How big a market these firms are addressing has not been reliably established, the ABI managers suggested. "Right now, most of the reports we've seen roll into the RNAi market as a whole, so it's hard" to determine the market size for microRNA research, Walworth said. But, she added, publication growth of microRNA research is "skyrocketing," and perhaps in six month's time market estimates will become more readily available.

A search on PubMed backs Walworth's assertion. Since 2001, 537 papers mentioning microRNA have been published on the site. Of that number, 218 have been published thus far in 2005.

ABI intends to develop further products in the microRNA area, though it's not disclosing any details. "We're not in a position to describe what they are at this point," Shelton said. "But, it's definitely a very active area."

— Edward Winnick ([email protected])

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