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Xceed Molecular to Debut RUO Ziplex Array Next Month; Plans FDA Submission in ‘08

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One year after rechristening itself Xceed Molecular to emphasize its orientation towards the clinical diagnostics market, the company formerly known as Metrigenix is preparing to launch a low-throughput and relatively affordable microarray platform called Ziplex next month. Xceed believes the platform will be attractive to clinicians that have been put off by the price and complexity of existing array-based tests.
 
Ziplex is an automated microarray system that performs pre-hybridization conditioning, hybridization, post-hybridization washes, chemiluminescent detection, image capture, data analysis, data quality control, and results reporting, according to Xceed.
 
The system uses Xceed’s Flow-Thru-Chip technology, where “TipChips” made of porous silicon with channels that extend from the upper to the lower surface of the chip are mounted on polycarbonate tubes. Molecular interactions occur within the three-dimensional matrix of these channels as target solutions pass through and a chemiluminescent signal is then detected and analyzed by Xceed’s software.
 
According to President and CEO David Deems, Xceed is planning to debut the Ziplex System at the American Association of Molecular Pathology meeting in Los Angeles in November. The system will be available for research use only at first, but Xceed expects to submit its first diagnostic assays on the platform to the US Food and Drug Administration in 2008.
 
Deems told BioArray News in an e-mail this week that Xceed already has developed a pipeline of diagnostic assays for use on the Ziplex and is pursuing licensing or partnership opportunities for access to more clinically relevant markers. These condition-specific arrays, called Signature Chips, will then become available to Ziplex users as catalog arrays or through a service.
 
The company already markets the Metabolic Signature Chip, which can be used to investigate differential expression associated with diseases of the metabolic system, such as obesity, muscle disorders, and other metabolic disorders. Deems said Xceed is currently designing additional chips for inflammation and for a range of cancers, including prostate, lung, colon, breast, and melanoma.
The evolution from array vendor Metrigenix to diagnostics developer Xceed Molecular has occurred relatively quickly. Founded as a spin-out from Gene Logic in 2001, Metrigenix was originally headquartered in Toronto and built its business around the same flow-thru technology utilized by the Ziplex System. In 2005, Metrigenix acquired Woburn, Mass.-based GeneXP Biosciences, a biomarker discovery firm, and relocated much of its operations to the Boston area (see BAN 6/15/2005).
 
Last year former CEO Michael Cohen said that the Ziplex would be available in November 2006, following the rebranding of Metrigenix to Xceed (see BAN 10/31/2006). However, the company opted for a slower rollout, building relationships with researchers like Gavin Gordon, co-director of the Thoracic Surgery Oncology Laboratory at Brigham and Women’s Hospital in Boston. Gordon detailed his work on the Ziplex during a presentation at IBC Life Sciences’ Discovery 2 Diagnostics conference in Philadelphia last month.
 
Reaching Clinicians
 
Now the firm is ready to more broadly launch the system and is touting its ease of use and price tag to woo clinicians into giving Ziplex a chance. According to Deems, the list price for the Ziplex Workstation, which automates the hybridization, imaging, quantitation, and quality control, is $85,000. The TipChips that contain the assay-specific content can “cost as little as $120 per chip”, he wrote.
 
According to Deems, the Ziplex System “allows you to perform testing at approximately one-third the cost and in one-third the time of conventional methods. After the sample preparation has been completed, the hands-on time to process up to eight samples is approximately 20 minutes,” while results are reported in roughly four and a half hours. Xceed claims that rival platforms typically have a 16-hour turnaround time.
 

“The primary driver affecting adoption of molecular diagnostics will be cost control.”

The promise of timely results at a lower cost has led Xceed to believe it has something that will interest clinicians and get them using arrays in their labs rather than sticking with more established methods, like RT-PCR.
 
“We’ve been previewing our system and presenting data at a number of important conferences over the past year and the response has been overwhelmingly positive,” wrote Deems. “There’s a great deal of interest in focused arrays – and there are few competitive alternatives,” he wrote. “People are looking for an easier way to do gene-expression arrays. We believe we can deliver superior accuracy, reproducibility, speed, and scalability at significantly lower cost and complexity than conventional array- or PCR-based systems.”
 
Xceed’s faith has not been matched by other companies in the array market though. Over the past year two microarray firms with similar hopes decided to pull the plug on their array businesses. First it was GE Healthcare, who in December 2006 announced plans to shutter its Codelink bioarray unit, stating that its arrays were “designed to measure thousands of genes, and thus cannot compete with the cost and ease-of-use attributes required to succeed in future clinical molecular diagnostics” (see BAN 12/19/2006).
 
More recently it was Nanogen CEO Howard Birndorf who stated that “tests for genetic-related disease conditions and drug metabolism are widely discussed but narrowly adopted in the healthcare industry” and that while it is clear that a market for array-based molecular diagnostics will emerge, the “unknown is how long that will take to happen.” Nanogen is currently evaluating strategic alternatives for its array business (see BAN 9/25/2007).
 
Even Illumina, a serious presence in both the array-based expression and genotyping markets, decided to develop a separate platform, the digital microbead-based BeadXpress, to deploy diagnostic content. "The sweet spot for diagnostic applications will be at multiplex levels between 10 and 150 markers," Illumina CEO Jay Flatley wrote in an e-mail to BioArray News in March. "Microarrays are overkill at this level of complexity and do not offer the flexibility or cost dynamics that this market demands" (see BAN 3/27/2007).
 
According to Deems, it is precisely Ziplex’s lower throughput, ease-of-use, and price that could make Xceed more successful than other array firms that have tried to penetrate the clinical market.
 
“The routine clinical laboratory will require a system that is reliable and easy to operate,” he wrote. Ziplex’s throughput is also lower, which enables the firm to charge a lower price.
 
“The primary driver affecting adoption of molecular diagnostics will be cost control,” Deems wrote.

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