NEW YORK (GenomeWeb) – Aushon Biosystems has been building up its IP portfolio ahead of a planned expansion to its Cira immunoassay platform. The Billerica, Mass.-based company said last week that the US Patent and Trademark Office has awarded it three patents since early March that describe methods for producing and carrying out ultra-sensitive protein biomarker analysis, an approach the firm is keen to commercialize.
CEO Susan Vogt discussed Aushon's IP position and its business strategy with BioArray News last week. According to Vogt, Aushon made the announcement about the new patents to show that the company will "continue to build IP around the platform," which she said "can be used in a lot of different ways."
Aushon was founded in 2003 and entered the microarray market three years later with the launch of the 2470 Arrayer, an instrument that is capable of printing DNA, proteins, and cell lysates using pin-based deposition technology. In 2009, Aushon expanded into the immunoassay market through its acquisition of Thermo Fisher Scientific's SearchLight business, and in 2012, the company introduced the Cira system, which includes both catalog and custom Ciraplex assays for protein biomarker profiling.
Vogt said that the next step for Aushon will be to introduce assays with single-digit femtogram per milliliter and possibly lower detection levels of proteins with "extremely high degrees of precision." Its current lowest level of quantification is 0.1 picograms per milliliter.
"With Ciraplex, we are looking at creating high-throughput methods for quantitative protein detection using multiplex panels, up to 12 analytes in a single well, so that you are getting results on 12 proteins simultaneously," Vogt said. The ultra-sensitive assays in development will complement Aushon's existing offering by being "focused on those proteins that are very hard if not impossible to detect today in normal samples in a quantitative fashion," she said. "We are driving the sensitivity down so that customers using our platform … can get to extraordinarily low levels of detection."
According to Vogt, Aushon is planning to make its ultra-sensitive assays available commercially by the end of the summer. "We will target the assays to those proteins which are expressed at extremely low and previously undetectable levels in normal human plasma such as cytokines and chemokines," Vogt said. She declined to elaborate further on the offering, but said it should appeal to Aushon's existing customer groups: pharmaceutical companies and translational research centers.
"Our customers are looking to screen lots of proteins, but they sometimes isolate some that are very hard to detect and differentiate with normal patients because they are not elevated," said Vogt. In that case, "having such extremely high sensitivity is going to bring additional value," she added. "They are going to be able to quantitate the levels of proteins in ways that they couldn't in the past using any other method."
Differentiating itself
Of the three new patents awarded to Aushon since March, two relate to its manner of making its Cira multiplex protein panels. US Patent No. 8,685,486 describes a method for applying blocking material to assay substrates, while US Patent No. 8,679,262 relates to a multi-chambered deposition pin wash station. As the company noted in a statement, the '486 and '262 patents cover technology used in the printing of complex protein arrays on a variety of substrates as well as the blocking process used to immobilize the biomolecules enabling the "fabrication of highly precise and robust panels."
Pete Honkanen, Aushon's founder and COO, said in a statement that the company's ability to create arrays through the "precise deposition and immobilization of very small amounts of complex materials in a wide variety of formats" remains the core of Aushon's technology.
The USPTO has yet to update its online database to show Aushon's latest patent, but Vogt said that the office informed Aushon of a patent allowance for Application No. 20,130,034,284 at the end of April. The firm's third new patent relates to technology used in its Cirascan imaging system to "increase the dynamic range for quantitative assays enabling detection of proteins at sub-picogram levels," according to the company.
As detailed in the patent application's summary, the described methods allow researchers to obtain composite images with enhanced dynamic range to be generated that "result in more accurate, reliable, and efficient chemical and/or biological analyses."
The methods include obtaining multiple images of pixels representing light intensity output from an assay, where the light intensity output indicates the presence and amount of a substance within wells of a test plate. According to the patent, the images are detected using a standard exposure time and a longer-than-standard exposure time, and both sets of images are calibrated to create the less noisy, more accurate composite images.
Vogt said that the ultra-sensitive assays enabled by the new IP are an extension of the firm's core markets. "As customers are looking at these biomarkers and using them to differentiate between different segments of patients, they need to be able to distinguish at greater levels of discrimination between different segments of patients," she said. "We have customers who are looking at markers that are indicative of some kind of effect, and in drug trials we have customers who are looking at groups of proteins as early diagnostics," she said. "So the level of sensitivity is important when you are looking at those kinds of applications."
Looking ahead, Aushon is hoping to use its new technology to differentiate itself from competitive offerings, which include traditional enzyme-linked immunosorbent assays, as well as other multiplex immunoassay systems sold by Olink Bioscience, Luminex, Life Technologies, and many others.
"This is something that a lot of companies are working on," said Vogt, "but because of the way our products are formatted, their ease of use, and very high throughput, we find that customers who are looking at high volumes of samples with lots of proteins prefer our platform." Vogt added that with Aushon's ability to develop ultra-sensitive assays on top of its existing offering, "customers that may be using traditional ELISAs or other platforms and have a need for very high detection will use ours."