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Rebranded and Refocused, Xceed Molecular To Launch RUO Chips and System Next Month

Metrigenix last week rechristened itself Xceed Molecular, which, according to a company official, is meant to convey a strategic shift as the firm prepares to launch content-specific arrays, customizable testing panels, and a benchtop research-use-only system in November.
Xceed CEO Michael Cohen said last week that while the firm will continue selling into the research market into next year, the company is now focused on making its technology relevant — and profitable — for clinical diagnostics applications.
Cohen told BioArray News that the company will begin rolling out its TipChip microarrays and benchtop Ziplex automated workstation next month. The firm’s TipChip arrays are based on its proprietary Flow-Thru Chip technology, which uses a microporous silicon substrate for biological analysis, and can supposedly enable hybridizations that are faster than rival microarray formats. According to Cohen, among Xceed’s first arrays will be a chip for metabolic disorders.
“Selectively we have and will continue to offer an increasing number of signature chips that come out of our own validation work or that of [our] collaborators,” he said. “The one that we have available now is a metabolic disease signature chip.”
According to Xceed, the Metabolic Signature Chip offers genes of interest for investigators exploring metabolic pathways. The chip can be used to investigate differential expression associated with diseases of the metabolic system, such as obesity, muscle disorders, and other metabolic disorders.
“We are working on several others. You can expect autoimmune [and] certain areas of oncology. They are really to enable researchers that are trying to … develop assays with clinical utility,” he added.
In addition, the company plans to offer users the ability to design their own assays using the Ziplex System which offers pre-hybridization TipChip conditioning, hybridization, post-hybridization washes, chemiluminescent detection, image capture, data analysis, data quality control and results reporting. The Ziplex System has been priced at $85,000, according to Cohen.
“Fundamentally, our offering is about enabling assay developers to run their assays on a custom chip. We can work with them to develop that chip,” he said.
While the word “clinical” certainly is a buzzword surrounding Xceed’s new platform, Cohen maintained that the system — which is currently offered through a service for early access customers — is strictly for research, though the company is positioning it for clinical usage.

“We have had discussions with the FDA about the most appropriate path for regulatory clearance of the instrument, and intend to continue to pursue FDA clearance in 2007.”

“Our initial launch of the Ziplex system, first for array services and then as an installed system, is for research use only,” Cohen wrote in a follow-up e-mail to BioArray News.  “We have had discussions with the US Food and Drug Administration about the most appropriate path for regulatory clearance of the instrument, and intend to continue to pursue FDA clearance in 2007,” he wrote.
As Xceed begins its push into the market, it will most likely meet competition from a variety of players, depending on the application of the Ziplex and TipChip technologies.
For example, GE Healthcare has stated that it plans to launch a metabolism array through its CodeLink bioarray unit in the first quarter of next year. GE recently told BioArray News that the metabolism chip will be a catchall that will package about 1,200 genes into a 16-assay format (see BAN 10/10/2006).
However, unlike Xceed, GE does not offer any instrumentation with its CodeLink arrays.
Other companies that could compete with Xceed in the custom array arena include Nanogen, which last year launched a 400-site array with the intention of targeting the homebrew market, CombiMatrix, which similarly sells a benchtop synthesizer for the manufacture of custom arrays, and Fluidigm, which also offers users the ability to develop customizable content.

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