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Fluidigm to Launch 96-Sample BioMark Chip This Year to Replace PCR, Arrays

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Fluidigm is preparing to launch a 96-sample array for use on its microfluidics-based BioMark system later this year, according to a company spokesperson.
 
Howard High told BioArray News last week that the company finished developing a prototype 96.96 Dynamic Array in December. The device, which can be used for both gene expression and genotyping applications, is configured to run 96 samples against 96 primer-probe sets to generate 9,216 reactions.
 
High said that Fluidigm will release evaluation prototypes to early-access customers and will fully launch the new chip format in the second half of the year.
 
Fluidigm last month filed with the US Securities and Exchange Commission for an initial public offering of common stock. Though the firm did not disclose how many shares it intends to offer, and the preliminary prospectus did not provide an estimated range for the offering’s share price, Fluidigm noted that the proposed maximum amount it intends to raise is $86.25 million (see BAN 4/22/2008).
  
The company manufactures two main systems, the BioMark, which is used for gene-expression analysis, genotyping, and digital PCR, and, the Topaz system, which is used for protein crystallization research. The BioMark was launched with an accompanying 48.48 integrated fluidic cartridge, or IFC, in 2006. The company has been touting the BioMark in particular as a platform that will challenge both microarrays and PCR-based platforms, such as Applied Biosystems’ TaqMan, for market dominance.
 
“Our IFC systems are designed to overcome many of the limitations of conventional methods by enabling researchers to rapidly perform a large number of experiments at one time and in nanoliter volumes, significantly increasing throughput, reducing reagent costs, conserving patient samples and reducing workflow complexity,” High said last week.
 
It is clear that higher-throughput PCR-based products, such as ABI’s TaqMan or SuperArray’s suite of PCR arrays, are the main potential rivals for Fluidigm’s products. “A single IFC based on our 96.96 format can conduct 9,216 real-time quantitative PCR or other assays, or 24 times the assays that can be conducted on a single 384-microwell plate,” High boasted.
 

“Our systems and technology also have advantages over other high-throughput methods for large-scale experimentation.”

However, he noted that the company’s IFCs are designed to work with common lab setups that will allow TaqMan users to easily adopt the platform into their workflows. “Our IFCs incorporate plastic input frames that are the same size as standard microwell plates and are designed to work with the most commonly used robotic pipetting systems, bar code readers, plate handling systems and other equipment,” High said, adding that the chips are also designed to work with “standard” real-time quantitative PCR techniques and TaqMan chemistries.
 
In terms of arrays, by offering gene expression, genotyping, and digital PCR, South San Francisco, Calif.-based Fluidigm will be in some cases a natural competitor to firms like Affymetrix and Illumina. According to High, Fluidigm’s main advantage will be its flexible IFC cartridges that will enable researchers to quickly design and tweak their assays.
 
“Our systems and technology also have advantages over other high-throughput methods for large-scale experimentation,” he said. “Unlike many microarrays, pre-formatted arrays and bead arrays, our systems offer a range of flexibility that allows researchers to dynamically specify and refine their assay panels during the course of a study.”
 
High declined to answer any questions related to the content of the company’s SEC filing.
 
A Move into Dx?
 
According to the SEC filing, Fluidigm will also look to attack the expression and genotyping markets by selling lower-cost chips. “For validation studies, which typically require the analysis of thousands or tens of thousands of samples, the high per-unit cost of microarrays and bead arrays often make them uneconomical,” the company said in the filing.
 
The company estimated the expression and genotyping markets together to be around $4.9 billion per year, with 8 percent annual growth expected through 2010. In terms of digital PCR, the company said that it is currently an emerging market, but that it has the “potential to grow significantly as new applications are developed.”
 
The company disclosed that its technology is likely to find a home in immunoassays, high-throughput drug screening, chemical synthesis, pharmacogenomics, systems biology, synthetic biology, and cellular assays.
 
The company said that it plans to spend the proceeds of the IPO on sales and marketing initiatives, including “significantly expanding” its sales force and to support the ongoing commercialization of its products. According to the filing, Fluidigm currently employs 24 full-time sales, support, and marketing personnel. The company has 130 employees in total.
 
In the filing, Fluidigm also expressed an interest in moving its research-only IFCs in the direction of molecular diagnostics. It noted that researchers have used the firm’s system to detect clinically relevant biomarkers, such as drug-resistant leukemia cells and fetal chromosomal abnormalities.
 
“We believe that the high throughput, flexibility, and simplified workflow of our IFC systems could make them an attractive solution for validating and commercializing a wide range of molecular diagnostic tests being developed by researchers,” Fluidigm said.
 
“In addition, we believe that our IFC systems’ ability to measure gene expression levels across a broad range and to detect nucleic acid sequences present in very low concentrations will support the development and commercialization of molecular diagnostic tests that would not be practical with conventional systems,” the company said. However, it said that it does not have any current plans to develop products that would be regulated by the US Food and Drug Administration.
 
Fluidigm, founded in 1999, acknowledged in the filing that it faces stiff competition from older, larger, and more established companies like Affy, Illumina, and Sequenom. It said that it would push ease of use, lower-cost arrays, and compatibility with existing technologies to cut out a piece of the market for itself.

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