Korean technology and test developer Seegene this week said that it has developed a new, real-time microarray platform that it claims eliminates the "burdensome, time-consuming" steps associated with current array technologies, and is "highly applicable" to point-of-care testing.
Dae-Hoon Lee, head of R&D at the Seoul-based company, told BioArray News that the firm is currently seeking a partner with expertise in array-based molecular diagnostics and instrumentation to design an automated system capable of running assays based on the new technology in the POC setting.
Established in 2000, Seegene has already brought ) to market multiple nucleic acid detection technologies, including its dual priming oligonucleotide, or DPO, and its tagging oligonucleotide capture and extention, or TOCE, technologies for multiplex real-time PCR. The firm, which maintains an office in Gaithersburg, Md., sells its own systems and kits and licenses its technologies to other companies. For example, in April, Seegene licensed DPO and TOCE to BioMérieux for use in the development of food-safety tests.
"We are still a technology development company, not just a product development company," said Lee. "We have lots of technology development in process and keep publishing and plan to stay in the technology development business," he said.
In the case of its new real-time array technology, Lee said that Seegene envisions partnering with an established array instrument provider, or a newcomer, to design an automated system that Seegene will bring to market with accompanying tests. He said that the firm already has a pipeline of oncology tests based on the platform, but did not provide additional detail.
Because of its reproducibility and real-time data, the proposed fully automated system would have advantages over existing array technologies on the market or in the development geared toward POC use, Lee said.
"If we applied our new technology, it might be possible to do fully automated detection and provide more information than is achieved currently," he said.
Main Hurdles
Seegene is one of several companies with array platforms eyeing opportunities in the POC market. Others looking to deploy array-based POC tests include Toronto-based Xagenic, which is developing assays for pathogen identification (BAN 6/25/2013); and Newcastle, UK-based QuantuMDx, which recently partnered with the Genome Institute of Singapore to develop an Asian population-specific test for cancer (BAN 5/28/2013)
Frederick, Md.-based Akonni Biosystems has also developed a platform based on its gel-drop array technology called TruDiagnosis that it markets as a "near-point-of-care molecular testing system." Akonni partnered with Seegene in 2011 to develop pathogen-detection panels using the DPO and gel-drop array technologies (BAN 5/10/2011)
According to Lee, Seegene created its real-time array technology in order to overcome perceived shortcomings with existing array technology, which he said have hindered its adoption in molecular diagnostics, particularly in the POC setting.
"In the 1990s and 2000s, there was a big boom in the array business, but it collapsed because of issues with false positives and reproducibility," said Lee.
"The main hurdle," he said, has been that every microarray assay requires several steps – amplification, hybridization, washing, and detection.
Seegene's approach has been to integrate these steps, so that amplification and single-stranded DNA generation are performed in liquid phase, and then hybridization and signal generation occur simultaneously on the array.
In its statement, Seegene touted a number of other attributes of its new technology. These include no size limitation for the PCR amplicon, no requirements for asymmetric PCR, no denaturation of the PCR amplicon, and no requirements for target-specific primer extension, signal amplification, or washing.
Because of these qualities, the new technology is a "significant development for the use of arrays in molecular diagnostics," and a "key enabler of array-based POCT," Jong-Yoon Chun, Seegene's founder, CEO, and chief technology officer, said in a statement.
Chun added that the firm is "initiating an aggressive licensing and OEM campaign to make this technology … available to a broad segment of the life science industry."