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Seegene Introduces New PCR Tech for Molecular Dx Testing

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By Ben Butkus

Molecular diagnostics firm Seegene this week introduced a new technology called real amplicon detection PCR and said that it plans to develop a number of molecular diagnostic tests based on the method in coming months.

According to Seegene, real amplicon detection, or READ, PCR, combines the advantages of multiplex and nested real-time PCR, accelerates test processing by 400 percent, and increases specificity and sensitivity of pathogen detection 10- to 100-fold over current technologies.

Seegene, which has offices in Rockville, Maryland, and Seoul, Korea, has been developing READ PCR for approximately five years, a company spokesperson told PCR Insider via e-mail this week.

The company is developing a line of diagnostic tests based on READ PCR called Magicplex. Tests for seasonal influenza A subtype H1, H3, and 2009 novel H1N1 are currently being sold in Europe and Asia, according to the spokesperson, but are not yet available in the US.

The official unveiling of the READ PCR method this week means that Seegene is making the technology available for testing and use by potential partners and customers, the spokesperson said.

Seegene is still keeping specific details of how the technology works under wraps, but said it will disclose some details in scientific papers that are currently being prepared for publication in peer-reviewed journals.

In the meantime, the company said that READ PCR is a departure from probe- and primer-based real-time PCR methods, and that it uses a new technique called dual signal generation, which works in a two-step process: first, it specifically amplifies the DNA sequences of multiple target pathogens, then reads those signals using conventional real-time PCR instrumentation.

The spokesperson also told PCR Insider that Seegene has another proprietary technology, called dual priming oligonucleotides, that, combined with READ, "overcomes the limitations of conventional PCR and real-time PCR testing methods, such as low specificity and sensitivity, limited multiplexity, high retest rates, long processing cycles, and narrow range of applicable specimens for testing." The technology is also capable of detecting multiple pathogens simultaneously, making it ideal for high-throughput assays, the spokesperson added.

In a description on Seegene's website of the dual priming oligonucleotide, or DPO, technology, the company says that in conventional PCR, "the inevitable risk of mismatched priming cannot be avoided in the currently used primer system, even through considerable time and effort are devoted to primer design and optimization of reaction conditions.

"A novel DPO system that is structurally and functionally different from the primer system currently in widespread use blocks extension of non-specially primed templates, and thereby generates consistently high PCR specificity even under less-than-optimal PCR conditions," according to the website.

In a statement, Seegene Founder and CEO Jong-Yoon Chun said that READ PCR "enables users to accelerate PCR processing by 400 percent while increasing specificity and sensitivity of pathogen detection from 10 times to 100 times over current technologies," meaning probe- and primer-based real-time PCR technologies such as TaqMan, molecular beacons, Scorpion probes, LUX, and Sunrise.

"New tests developed with the READ platform means clinics will be able to provide better patient care, while reference labs will be able to test a wider range of pathogens with remarkably higher specificity and sensitivity," Chun added.

Besides the influenza tests based on READ, Seegene has identified as a priority the development of a kit to detect vancomycin-resistant genes vanA, vanB, and vanC, which can cause problems in treating infections caused by bacteria such as Staphylococcus aureus and Clostridium difficile.

"We view identifying [vancomycin] resistance as a major unmet medical need, [which] is why we focused on developing this test," the spokesperson said. "The Magicplex VRE test is able to simultaneously detect these three vancomycin-resistant genes, greatly aiding infection control in hospitals and intensive care settings to prevent nosocomial outbreaks."

According to the company, while tests based on conventional cultured broth or rectal swabs take four to five days to process, the Seegene test is expected to provide results in less than five hours.

Seegene is currently developing a broad range of other pathogen- and mutation-detection assays based on READ PCR, and eventually plans to launch at least one new product per month based on the technology, the spokesperson said, without elaborating on when the company's next product launch would be.

Seegene's spokesperson also said that the company has "a host of clinical studies in progress in hospitals in Korea, the results of which we will make public" in approximately three months.

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