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Axela Acquires Xceed Molecular to Bolster Biomarker Discovery Business

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By Justin Petrone

Axela, a Toronto-based clinical research firm, this week acquired Xceed Molecular for an undisclosed sum. Axela to date has focused on providing protein analysis tools and services, and the addition of Xceed's Ziplex System for gene expression analysis will support its ambitions to speed the validation and clinical application of DNA, RNA, and protein biomarkers.

Axela CEO Rocky Ganske said in a statement that Xceed "provides a tremendous opportunity to accelerate introduction of novel multiplex biomarkers for diagnostics."

The focus of the combined firm, which will operate under the name Axela, is to "simplify multiplex assay development and validation … for analysis of DNA, RNA, and protein biomarkers that are designed to move seamlessly from the clinical-research arena into the workflow of the clinical-diagnostics lab," Ganske said.

"From a big-picture perspective, it's become very clear that clinically important biomarkers will cover the gamut – protein, DNA, or RNA," Xceed President David Deems told BioArray News this week. "In order to make translational medicine a reality with a seamless transition from research lab to clinical lab, we recognized that we needed to address the continuum of biomarkers," he said. "In that regard, Axela and Xceed are a powerhouse combination."

Indeed, the post-acquisition Axela plans to combine its multiplex protein biomarker testing capabilities with Xceed's Ziplex for gene expression analysis to offer clinical researchers a portfolio of products for analysis of proteins, pathogens, DNA, and RNA.

Ganske will remain CEO of the firm, while Deems will serve as president of Axela, responsible for sales, marketing, and business development. The firm will employ 42 staffers and will relocate its headquarters to Xceed's microarray product-development facility in Toronto. Xceed's sales, marketing, and business development activities have in the past been conducted from its US headquarters in Wellesley, Mass.

Deems said this week that the Wellesley office is now closed, though Axela hopes to establish a US presence in the future once it concludes another round of financing, which the firm anticipates will close later this year or in early 2011.

Xceed was founded in 2003 as MetriGenix to commercialize its Flow-Thru Chip technology, which uses a microporous silicon substrate that Xceed claims can provide relatively faster hybridization than other array substrates. In 2004, it acquired Wellesley, Mass.-based biomarker discovery firm GeneXP Biosciences, and in 2006 rechristened itself Xceed to reflect a new focus on molecular diagnostics (BAN 10/31/2006).

Xceed's flagship platform is the Ziplex, 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. Launched in 2007, the system supports assays run on Xceed's TipChips, which are made of porous silicon with channels that extend from the upper to the lower surface of the chip and are mounted on polycarbonate tubes.

According to the firm, 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 (BAN 10/9/2007).

In recent years, Xceed has rolled out a series of Xpress Chips for a number of indications, including its Metabolic Xpress Chip for the study of diseases of the metabolic system, such as obesity, muscle disorders, and other metabolic disorders; the Colon Cancer Xpress Chip, which contains genes expressed in colorectal cancer tumors or cells; the Breast Cancer Xpress Chip, which enables differential gene expression analysis of breast cancer-related genes; and the Inflammation Xpress Chip, which detects and quantifies inflammatory markers. Xceed also manufactures custom Autograph Chips for customers, and provides gene expression services on the Ziplex platform.

Deems said that the company is currently validating Xceed's Breast Cancer Prognostic Assay, which uses a gene-expression signature to predict risk of recurrence for breast cancer patients, and is working toward a planned commercial launch of the assay next year that will entail a 510(k) submission to the US Food and Drug Administration.

"We have been in discussions with FDA staff about the requirements and our approach," said Deems. "Timing is always difficult to predict in regulatory matters, but our goal is to have our submission in to the Center for Devices and Radiological Health sometime during the first half of 2011."

In addition, he said Axela has other diagnostic programs underway and is "well-positioned to improve diagnostics in infection, cancer, and other immune-related diseases."

For example, researchers at Emory University have used Xceed's Colon Cancer Xpress Chip to develop a renal cell carcinoma signature for use as a laboratory-developed test. The newly combined company will discuss the work with Emory at the 2010 American Association of Clinical Chemistry annual meeting in Anaheim, Calif., this week.

In addition to these programs, Deems said that a "number of prominent translational-research labs have been using the Ziplex system to validate their biomarkers for potential use as laboratory-developed tests" in areas such as "follicular lymphoma, colon cancer, renal and lung transplantation, renal cell carcinoma, and ovarian cancer."

Until the acquisition of Xceed, Axela's core offering was its four-year-old dotLab System, which uses the firm's diffractive optics technology to provide real-time measurements of proteins. The benchtop dotLab supports the firm's panelPlus configurable multiplex assays, which allow users to measure their proteins of choice.

Deems said the dotLab can be used to support multiplex protein signatures for diagnostic assays, though there is no specific test that is targeted at this time. Several dotLab customers are evaluating the feasibility of using the system for laboratory-developed tests using their protein signatures, he added.

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