Contract research organization BioReliance this month launched a new array service for the screening of non-human antigens in animal serum, the first fruit of a new technology-development strategy the company embarked upon after being sold by Invitrogen last year
The array platform, called ReliArray, currently in beta testing and available only to select customers, will formally debut in January, replacing the ELISA technology currently being used by BioReliance for serological testing, Scott Hickman, senior product manager of BioReliance, told ProteoMonitor.
ReliArray is the first technology developed by BioReliance to be launched since Invitrogen sold it in early 2007 to private-equity firm Avista Capital Partners. But it won’t be the last as the Rockville, Md.-based company is continuing to develop other technologies, Hickman said.
“We have definitely a reinvigorated interest in development of new technologies, and this is one of those initial offerings of that reinvigorated interest,” he said.
The total worldwide serological-screening market is between $5 million and $10 million, he estimated. BioReliance’s share of that, he added, could be “potentially several millions of dollars.
“This is a sector in biotech businesses, in pharma [where we have] great potential to reach out and find not only new customers, but … to add even more definitive, more reliable support” to existing customers, he said. “We’re getting a much more sensitive, more reliable assay. It’s basically bringing to them more dependable results than what they’ve gotten from anybody.”
The first iteration of the ReliArray platform is designed to detect antigens for the four most-requested pathogens in non-human primates: monkey B virus, simian retroviruses, simian immunodeficiency virus, and simian T-cell lymphotropic/leukemia virus. Eventually, the slides will include antigens to other pathogens such as measles and tuberculosis.
Next year, Hickman said, the technology will be used for BioReliance’s rodent arrays. Initially, that will cover mice and rats, and eventually rabbits and guinea pigs.
“What we have been tweaking and what we will have to tweak … is how those individual antigens are loaded on [to the array] and the optical densities that need to be read so that we can get a proper reading, compare it to standard technology … that’s been out there such as an ELISA [and] Western blot,” Hickman said.
“We looked at protein array in general as a new technology that’s taking off not only for specific diagnostics for screening as we’re doing, but as a nice reliable platform that people have vetted out.”
The ReliArray platform is based on standard protein-array technology in which protein spots are printed onto a slide. What is different is BioReliance’s proprietary analysis software, which collects and quantifies the data.
For serological screenings, ELISAs have been the state-of-the-art technology, but according to BioReliance, ReliArray offers faster and more reliable results. Hickman said the ReliArray has a specificity of 97.9 percent and a sensitivity of 99.7 percent, levels that are “unheard of for serology diagnostics,” he added.
According to the company, other advantages of the ReliArray over ELISAs include the use of fewer samples: fewer than 10 microliters on the ReliArray versus 100 to 200 microliters on the ELISA; improved quality control from built-in redundancy in sample reads; and lower variability.
Each ReliArray slide consists of 24 array blocks and each slide, which holds up to 100 antigens, can test up to 22 samples.
“You’re also able to build in different controls and different materials such as positive [and] negative control … so that you can read and know that you’ve built in quality control, that your batch is reading correctly,” Hickman said.
The readings are done in quadruplicate: four different slides are read, side by side, “so it looks eventually exactly like a 96-well plate, just as it would look like for an ELISA.”
This, he said, ensures that the results being read are accurate. A standard laser scanner is used for an OD reading, and using its proprietary software, BioReliance will determine the results of the test. Anyone who does animal testing, whether it’s for the development of biologics, therapeutics, or diagnostics, would be able to benefit from the ReliArray platform, he added.
The plan for now is to use the platform in-house exclusively as a service, but it could be potentially sold as a stand-alone product, Hickman said. Based on how it is received by its service customers, BioReliance will evaluate ReliArray’s potential as a retail product, he added.
The launch of ReliArray comes amid building interest in protein-array technology. While mass spectrometers continue to be the dominant technology in proteomics, protein and antibody arrays are beginning to gain a foothold in the field as a research tool. As a result, commercial players are also showing increased interest in the technology.
During the summer, Promega officials told ProteoMonitor that the company will be making its initial foray into the protein array space by launching functional arrays by the end of the year [See PM 09/04/08]. Akonni Biosystems said last month that it is using a $296,316 grant from the National Institutes of Health to develop a protein array-based diagnostic for respiratory infections.
And Auguron BioSciences is continuing work on a technology called nucleic acid-programmable protein array, or NAPPA. The technology was developed by Joshua LaBaer at Harvard University [See PM 05/15/08].
Since being acquired by Avista, BioReliance has been busy on the technology-development front and chose to enter the protein-array field because it views arrays as an emerging technology with commercial appeal, Hickman said.
“We looked at protein arrays in general as a new technology that’s taking off not only for specific diagnostics for screening as we’re doing, but as a nice, reliable platform that people have vetted out,” Hickman said. “People are aware of it, and it has a [promising] future [and] that’s why we investigated it. … It fit perfectly into our needs here.”
The company has other R&D projects ongoing, including work directed at proteomics, though Hickman declined to be more specific.
“We have a large and vested interest in [the] research and development of technologies. Proteomics is certainly one of those potentials, and more will be coming out in the future,” he said. “But this is the first wave of that … choosing [laboratory animal diagnostic services] and a very specific area that had a direct market that needed to be addressed.”