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Seegene Fully Discloses New Multiplex qPCR Tech; Launches New Molecular Tests

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Seegene this week fully unveiled its newest technology, a PCR chemistry that may enable real-time PCR-based detection and quantification of up more than 20 analytes from a single sample and in a single tube using existing multiplex-enabled thermal cyclers.

Seegene also unveiled four new molecular diagnostic assays – for respiratory viral pathogens, human papillomavirus, tuberculosis, and sexually transmitted disease — based on the new technology.

The technology, called quantitative tagging oligonucleotide capture and extension, or qTOCE, is an artificial template-based detection technology that delivers real-time signal generation and allows for multiple melting temperature analyses per optical channel of a real-time PCR system, thus allowing the system to simultaneously detect and quantify as many as seven targets per channel from a single sample in a single reaction.

The current multiplexing limit of current commercial quantitative real-time PCR assays is around five or six targets due to spectral overlap of fluorescent probes.

Seegene, based in Seoul, Korea, with an office in Gaithersburg, Md., first disclosed the new technology in late May, noting that it was the next generation of a technology that it had first introduced in 2011 at the American Association of Clinical Chemistry meeting (PCR Insider, 5/31/2012).

However, Seegene had kept the meaning of the TOCE acronym a secret, as it did not want to give away the nature of the technology as it pursued patent protection.

The company said this week that it would be demonstrating the qTOCE technology again at the American Association of Clinical Chemistry meeting, slated to begin next week in Los Angeles.

At the meeting, Seegene will also introduce four new molecular tests based on qTOCE: QuantPlex RV-16, an assay that detects, differentiates, and quantifies 21 respiratory viral pathogens associated with upper respiratory disease; QuantPlex HPV28, an assay to detect, genotype, and quantify 19 high-risk and nine low-risk HPV types; QuantPlex MTB/MDR/XDR for detecting Mycobacterium tuberculosis and resistance mutations associated with multiple and extensive drug resistant strains of the bacterium; and QuantPlex STI-7 for detecting and differentiating seven sexually transmitted pathogens.

Seegene said that its assays can theoretically be used on any multiple-channel real-time PCR instrument. The company is currently validating qTOCE assays on the Life Technologies ABI 7500 and Bio-Rad CFX 96 systems.

Seegene sells several of its diagnostic products in various countries outside the US, but none of its tests is approved for in vitro diagnostic use in the US.

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