An R&D breakthrough made earlier this year has enabled Aushon Biosystems to upgrade its arrays, which the company will re-launch later this month along with a rebranded imaging system and software.
Rocco Raduazo, the company's vice president of sales and marketing, told BioArray News this week that the new system is based on the firm's discovery that spotting arrays in 96- and 384-well plates in a circle, rather than the traditional rectangular format, led to better assay performance.
"Where you spot in a well is critical in terms of assay performance," Raduazo said. It is the company's experience that if an assay does not perform to expectations, the problems typically arise from "deadspots" in the center of the arrays, which typically contain nine or 12 spots, printed in rows of three by three or four by four.
By spotting an array in a circular pattern, Aushon has been able to attain higher sensitivity and coefficients of variability "well below 5 percent," Raduazo said. He attributed the improvement in assay performance to a meniscus effect, where the concentration of the proteins is higher on the capture antibody spots on the external rows of the array. Raduazo said that during the assay process, as plates are shaken to accelerate the mixing of solutions, proteins have a tendency to become even more concentrated at the sides of the wells. By printing its arrays in a circular pattern within the wells, the company can avoid the "deadspots" at the center of rectangular-patterned arrays that reduce assay performance, he said.
After making this discovery in January and filing patents for the circular patterning of both "small molecule and large molecule applications," the Billerica, Mass.-based firm validated its new approach with a British pharmaceutical company that Raduazo declined to name.
Other early adopters include scientists at Memorial Sloan-Kettering Cancer Center and Duke University Medical Center. Andrew Nixon, co-director of the Phase I Biomarker Laboratory at Duke, said in a statement this week that the data from Aushon's new system has been "very encouraging," and that the "sensitivity and consistency were equivalent to or better than" singleplex, enzyme-linked immunosorbent assay results for the markers Duke evaluated.
This feedback has compelled Aushon to press ahead with the launch of a protein biomarker platform that will consist of a menu of circularly printed arrays, its SignaturePlus imaging system, and its ProArray Analyst software. Aushon launched SignaturePlus and ProArray Analyst last year, and both will likely be rebranded in coming weeks, ahead of a June 15 launch date, Raduazo said. "The data looks great, and my team is rock 'n' roll — ready to sell it."
Aushon will sell the platform through its direct sales team in North America and Europe. In addition, Thermo Fisher Scientific will distribute Aushon's immunoassay products and services in North America, primarily targeting the academic segment.
Aushon spots its arrays using its 2470 Arrayer, which is capable of printing DNA, proteins, and cell lysates using pin-based deposition technology. Aushon launched the 2470 in 2006 and it was the firm's flagship product until it acquired Thermo Fisher Scientific's SearchLight protein array business in 2009, adding catalog and custom array products and services to its portfolio (BAN 3/19/2009).
According to Raduazo, Aushon is in the process of revalidating its catalog arrays since it introduced the new circular format. The company will launch five arrays with the new system on June 15, and will ultimately offer 28 "master arrays" consisting of about 200 biomarkers in total in the new format. The company's arrays will contain 12 biomarkers each. While Raduazo said that Aushon can technically put more content in each well, "more isn't necessarily better," and a 12-plex format provides "the cleanest data in a multiplex fashion."
The SignaturePlus imaging and analysis system includes a desktop imager with optics designed for the firm's quantitative chemiluminescent protein arrays. It has a list price of $43,000. ProArray Analyst software enables users to analyze protein arrays of various sizes in a plate format and incorporates ELISA analysis features, such as curve fitting, mean values, coefficient of variation, and standard deviation, according to the firm.
Though the imaging system and software only became available last year, Raduazo said that sales of the system and related consumables, including array kits, now comprise half of Aushon's revenues, with array services providing about 30 percent of revenues, and instrument placements supplying the remaining 20 percent. As Aushon is privately held, Raduazo declined to provide more detailed revenue numbers, but he said the company has seen "record orders" in recent quarters, and expects the launch of the new system to further spur revenue growth.
The firm is specifically targeting customers who use ELISAs. The ELISA market is large — it is estimated by Global Industry Analysts to reach $75 million by 2015 — and has numerous players, including Life Technologies, Molecular Devices (part of Danaher), and R&D Systems. Aushon CEO Pete Honkanen said that while protein arrays offer the ability to survey multiple markers per well, most researchers have not been swayed to switch, citing the better performance of ELISAs.
"Based on feedback gathered over the past several years, scientists in general have been dissatisfied with the performance of earlier generation multiplex systems," Honkanen said in a statement. "They love the idea of what multiplexing can deliver in terms of overall lab productivity, reduced sample consumption, and lower cost per study, but are seeing relatively poor performance vis-a-vis traditional ELISA, which has constrained the growth in the use of these platforms in the protein biomarker market," he said. With its new platform, Honkanen said that Aushon is "confident" that it has "addressed that issue."