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Decision Biomarkers Ships First Workstation Plans to Make Market Debut in January

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Decision Biomarkers shipped its first Avantra Q400 Biomarker Workstation to an undisclosed drug company last week, marking its transition from an R&D shop to a revenue generator.
 
The platform, used for biomarker detection, doesn’t launch officially until the second week of January, though DB did a pre-market launch late last year to establish beta test sites.
 
The company plans to ship additional units next month, President and CEO Roger Dowd told ProteoMonitor this week.
 
In late November, the US Patent and Trademark Office granted the Waltham, Mass.-based company a patent for a technology covering an ultra-thin nitrocellulose surface chemistry enabling the detection of low-abundance proteins.
 
The company’s future, however, rests on its Avantra platform. Since its founding in 2003, DB has been developing the system, which Dowd said offers full automation for assaying biomarkers in a quick and easy manner.
 
“We’re going from a development company into a commercial venture,” Dowd said. “We’re developing revenue now, so there’s a tangible sense of excitement all through the halls here.”
 
According to the company’s website, the Avantra system, which sells for around $40,000, enables researchers to test up to 40 biomarkers at once. A researcher puts serum or plasma samples into a biochip that’s then placed into the workstation. The chip contains antibodies that bind to specific proteins and fluorescent dye markers. When the dye attaches to a detector antibody, the tagged protein glows.
 
A charged-couple device camera takes a picture of the glowing antibody, and software analyzes the light emission and determines which protein has been activated on the chip and to what degree. Those that have been activated indicate disease.
Unlike an ELISA test, a standard curve of deviation is not needed because it is programmed into the chip.
 
According to Dowd, Avantra was designed specifically for individual investigators and researchers with limited experience running immunoassay platforms. With protein biomarkers now being used to hunt new drugs targets, biomarker identification has moved outside of core labs and into pharmaceutical and biotechnology labs and smaller research environments.
 
“Many people outside of central labs are very interested in getting immunoassay data but they’re just not equipped, and they don’t have the infrastructure to do it,” Dowd said. “This system in a box is all the infrastructure that it needs.”
 
Another application is in “adaptive” clinical trials where people need real-time data to make course corrections in the midst of a trial. Because of its ease of use, the Avantra can be used at the point of collection at a clinical trial site, Dowd said.
 
The data generated by Avantra is comparable to the bigger and more expensive immunoassay systems being used in core labs, he said. The coefficient of variance is about 10 percent, “which is as good [as] or better than most multiplexing immunoassay systems out there.”
 

“This system in a box is all the infrastructure that it needs.”

One area that the Avantra does not compare to other immunoassay systems such as Luminex’s multiplexed bead system or Pierce Searchlight’s product is in throughput. Whereas systems running on a 96-well plate can run thousands of samples weekly, Avantra is limited to dozens, Dowd said.
 
However, he said that DB does not see itself as a competitor to Luminex or Pierce because they service core labs, a market that DB is not targeting.
 
Patrick Sluss, director of the Reproductive Endocrine Unit Reference Laboratory at Massachusetts General Hospital, has been using the Avantra for about a year a half for cancer biomarker discovery.
 
The ease of use of the platform has been a main drawing point, he said, because without the need for extensive training on the machine, labor costs have been reduced. The system, he said, is most appropriate for biomarker discovery programs, such as his own, with limited access to tissue samples where lower throughput won’t be an issue.
 
DB is now focused on developing a “whole family of biochips” with different panels of protein markers for use on the Avantra. It is shipping a cytokine panel and an angiogenesis panel, and in February, the company will launch a cardiovascular panel. It has plans to develop panels for toxicology and central nervous system ailments.
 
Never Too Thin
 
Late last month, the company was granted patent number 7,297,497 for its PATH technology used in its protein microarray glass slides. Such slides have generally used nitrocellulose or polystyrene surfaces to immobilize proteins, but their high fluorescence creates substantial background noise, making it difficult to detect low-abundance proteins.
 
The PATH technology involves a film of nitrocellulose, or polystyrene, that is one-tenth of a micron thick and coated on an opaque surface that allows it to capture proteins while giving “a very low background” when used with fluorescent labels.
 
The patent also covers a novel surface-activation method using a high-energy corona treatment giving the slides a high binding capacity. Slides using the PATH technology are manufactured and distributed by GenTel BioSciences and Pierce Biotechnology.
 
According to Dowd, slides using the PATH technology can detect proteins one order of magnitude lower than other nitrocellulose protein array slides on the market.
 
In February 2006, the company pocketed $7.6 million in a second round of Series A private equity financing. DB has received additional funding since then, Dowd said. He declined to provide details.