Xceed Molecular, a Wellesley, Mass.-based company with molecular diagnostics ambitions, is narrowing down its areas of diagnostic interest and laying the foundation for a 510(k) submission to the US Food and Drug Administration next year, according to a company official.
CEO David Deems told BioArray News last week that Xceed has "honed in on several diagnostic areas," including breast cancer and colon cancer, and is currently involved in developing assays that will eventually be used by clinicians.
"We are doing clinical feasibility studies, developing our predictive algorithm, and starting conversations with FDA about what to do with tests like these," Deems said. He said that Xceed decided to engage the FDA early in the development process because the agency's "thinking on these types of tests is evolving" and the company would like to "stay connected to whatever approach they are thinking of putting in place."
Xceed plans to put all tests developed on its platform through "some kind of FDA clearance," Deems said, and the firm will use its ongoing dialog with the FDA to guide its efforts toward eventual clearance.
"We are hoping to have our first diagnostic assay out in 2010, but that will be driven by the FDA's feedback," said Deems. "We’ll have a much better idea by summer of how long it is going to take to run a clinical study."
In addition to planning the launch of its first diagnostic assays, Xceed also hopes to raise funding this year. Deems said that the company will be initiating its Series B round sometime this quarter or next quarter. The funding is intended to continue the work on the diagnostic assays and support their initial launch, Deems said.
Founded as MetriGenix in December 2003, the company raised $15 million in Series A financing in 2004 and changed its name to Xceed in October 2006 to reflect its transition from a research company to one aspiring to a role in the molecular diagnostics market.
Xceed's array platform is centered on its Flow-Thru Chip, a microporous silicon substrate for biological analysis. The company also sells the Ziplex automated workstation for gene-expression analysis. The platform makes use of Xceed's theme and custom-designed, three-dimensional TipChip arrays, which are capable of surveying 484 features per chip.
Though it is currently for sale in the US and Canada and intended for research use only, Deems said that the Ziplex was designed with the clinical market in mind. The Ziplex "does not have the flexibility that someone doing discovery work might want," Deems said. "It is designed for somebody who is working in a CLIA-compliant lab or CLIA-like lab, where they are looking to run many samples in a reproducible way with entry-level automation."
The list price of the system is $85,000, and it provides gene-expression analysis, from hybridization to result, in less than five hours, Deems said. "Our goal is to create building blocks that can be put together in a clinical lab."
Xceed launched the Ziplex in November 2007. At the same time, it launched a program to attract strategic collaborators to prepare the system for eventual clinical use (see BAN 10/9/2007).
So far, researchers at the Center for Molecular Medicine in Grand Rapids, Mich.; the University of Florida; Queens University in Kingston, Ontario; the H Lee Moffitt Cancer Center and Research Institute; and the University of Louisville have joined the program.
Deems said that it is likely that the first two assays to come out of the strategic collaborators program will be developed in conjunction with researchers at Moffitt and Louisville.
Last June, Xceed licensed from Moffitt the rights to use a gene signature for colon cancer to develop a molecular test that can predict patient prognosis for the disease. Xceed is working with Moffitt researchers, led by Tim Yeatman, to complete clinical development and validation of the signature, which uses biopsy tissues from colonoscopies to predict the chance of the disease returning (see BAN 6/10/2008).
In November at the Association for Molecular Pathology meeting in Grapevine, Tex., James Wittliff, a professor of biochemistry and molecular biology at the University of Louisville, presented data on predicting breast cancer outcome using gene expression signatures on the Ziplex.
Neither Yeatman nor Wittliff responded to e-mails seeking comment for this article.
Deems said that the company has now ceased expanding the partnership program, but that it has been a success for Xceed. He said Xceed is now focused on selling the Ziplex directly to clients, rather than working with new strategic partners.
A side benefit of the strategic collaboration program has been the launch of several focused TipChips, called Xpress chips, for research use on the Ziplex system. In September, Xceed debuted its Colon Cancer Xpress Chip for comparing gene expression profiles in human colorectal carcinomas and normal colorectal tissue, and its Breast Cancer Xpress Chip for differential gene expression analysis of breast cancer-related genes.
Xceed also offers an Inflammation Xpress Chip for detecting and quantifying inflammatory markers, and a Metabolic Xpress Chip for investigating differential expression associated with diseases of the metabolic system, such as obesity and muscle disorders.
Deems said that Xceed is interested in making such chips available in areas of "high interest" for its customers. He said that the company will add other theme arrays to its pipeline, but that it wants to "be very informed to determine where interest for Xpress chips lies, [and] based on that interest, what genes are most appropriate to include in a product."