Aushon Biosystems will debut later this year several new protein array-based assays designed to measure organ toxicity that it hopes to sell to pharmaceutical companies for use in drug-efficacy trials.
The new panels will build on assays Aushon launched earlier this month that are designed to enable users to quantify seven biomarkers related to drug-induced vascular injury. The vascular injury panels use the company's SearchLight protein array technology, a multiplex, sandwich enzyme-linked immunosorbent assay system based on the chemiluminescent or infrared detection of analytes.
Christine Burns, Aushon's vice president of assay R&D, said last week that the firm plans to extend its vascular injury panel to encompass more proteins, and is developing more panels aimed at helping researchers measure specific organ toxicity, such as kidney, liver, lung and muscle, across multiple species.
Burns told BioArray News that Aushon's new panels have grown out of its cooperation with pharma customers. "We certainly are very responsive to our clinical partners' requests, and we have over 300 validated assays from working with different customers," Burns said. "More recently some have asked for proteins that can measure toxicity, and we have had requests to look at lung toxicity, hepatic toxicity, and other areas. We hope to develop panels for human and other species and make them available to customers for use in efficacy trials."
According to Burns, Aushon expects most of the new panels to become available by the end of this year. The assays will run on Aushon's SearchLight Imaging and Analysis System, and will be offered as kits to customers for use in their own facilities or as a service through Aushon's Clinical Laboratory Improvement Acts-compliant lab.
Aushon spokesperson Alan Poon said in a follow-up e-mail that the creation of the new panels was prompted by "recent findings of vascular injury during pre-clinical testing for certain drugs." Researchers performing clinical trials of drug-induced vascular injury "need to understand and identify biomarkers that will help determine the risk involved," Poon said.
The company estimates that the total worldwide toxicology market is currently worth approximately $1.5 billion. Of this, biochemical assays such as Aushon's vascular injury panels comprise a $150 million slice, and are believed to be growing at a rate of 5 percent annually, Poon added.
The 'Quickest Avenue' to Diagnostics
Aushon last year paid an undisclosed sum for Thermo Fisher Scientific's SearchLight protein-array business and related assets (BAN 3/17/2009). SearchLight's personnel and assets, which included a CLIA lab, were transferred from Woburn, Mass., to Aushon's expanded Billerica headquarters in September 2009 (BAN 9/15/2009).
The company, which initially entered the market in 2005 with its 2470 arrayer instrument, acquired SearchLight in part to establish itself as a provider of catalog and custom protein-array kits, with a long-term plan to move into molecular diagnostics.
Chief Operating Officer Joseph Blanchard said that the firm decided to introduce panels related to vascular injury first because "there is a lot of work going on to validate these markers in preclinical models and the potential that the [US Food and Drug Administration] might mandate use of these [markers] in clinical trials."
Aushon, in general, is interested in oncology for several reasons. First, oncology presents the "largest need to improve productivity in drug development" and to "improve the success rate" for drugs, Blanchard told BioArray News last week.
Aushon also has a "midterm aspiration" to move into the diagnostics area, and views oncology as the "quickest avenue" to do that. Moving into diagnostics will require Aushon to spend more time working in oncology and "looking at other pieces that could involve an acquisition," Blanchard said.
While Blanchard did not elaborate on Aushon's diagnostics strategy, CEO Peter Honkanen said that the company has always planned on building up from its initial instrument offering to enter other, larger markets.
"We developed the printing technology as a foundation to allow us to develop multiplex assays of complex materials," Honkanen told BioArray News last week. "We see the growth of our company based on using that core technology to address the multiplex assay market, by working with pharma customers in preclinical and clinical trials."
As Aushon's focus shifts to its multiplex assay business, the company is still refining its arrayer offering. Last month, the company announced that the Institute for Molecular Medicine Finland, or FIMM, aims to launch a cell microarray screening research program that uses the 2470 (BAN 3/30/2010). The program will consist of miniaturized RNAi screens, and in the future will include compound/drug arrays, FIMM and Aushon said at the time.
"We believe that the print technology is a foundational technology for Aushon, and as such we will continue to develop the technology, and launch or realize that development in the arrayer product line," Honkanen said. He said that deals with partners like FIMM will "benefit" the company going forward because by "learning more and more about the needs and requirements of customers vis a vis the technology, we can refine the arrayer product line."
Blanchard said that Aushon continues to place 2470s, in part because the system has been optimized for use with reverse-phase protein arrays developed by George Mason University researchers Lance Liotta and Emanuel Petricoin and Satoshi Nishizuka at the US National Cancer Institute.
"We definitely see growth in the proteomics space," Blanchard said. "Reverse-phase arrays are difficult to print, and this an area where we excel. Most people doing RPAs are using our technologies and that is an area that is growing substantially."