LOS ANGELES (GenomeWeb News) – Seegene intends to pursue an aggressive partnership strategy to promote adoption of its newly released multiplex real-time PCR technology, officials from the Seoul, Korea-based firm told GenomeWeb Daily News at the American Association of Clinical Chemistry meeting held here this week.
The firm introduced the new technology, called quantitative tagging oligonucleotide capture and extension, or qTOCE, last week. It is an artificial template-based detection technology that delivers real-time signal generation and allows for multiple melting temperature analysis per channel.
Seegene Founder and CEO Jong-Yoon Chun told GWDN that although real-time PCR has been the gold standard for molecular diagnostic testing, current multiplex MDx technologies are hampered by "one-channel, one-target" testing. He said that Seegene's technology presents the opportunity to turn existing qPCR instruments into systems that can simultaneously detect and quantify multiple targets in a single channel. The technology has the potential to detect and quantify more than 20 analytes from a single sample in a single tube, the company said.
Though the firm is developing its own assays to take advantage of the qTOCE's benefits, it also aims to sign many collaborations with other molecular diagnostic firms and pursue companion diagnostic deals with biopharma firms.
According to Seegene Executive Vice President David Dollinger, the company intends to follow the licensing model offered by Roche over a couple of decades with its PCR patents, aiming for a broad user base. However, Seegene also wants to be an active collaborator with firms in developing their assays, because it believes it is offering an industry game-changing technology.
Chun and Dollinger said that Seegene expects to announce between three and five collaborative agreements this year for qTOCE, with many to follow. In addition, they said the company has had "a number of inquiries already" from biomarker developers and pharmaceutical firms.
Chun also said the firm expects "a hundred papers" on the technology to be published over the next year or so, which Seegene believes will help drive adoption.
Seegene has already developed four new assays that are based on the new technology: the QuantPlex RV-16 Assay to detect, differentiate, and quantify 21 respiratory viral pathogens; the QuantPlex HPV28 Genotyping Assay for detection, genotyping, and quantification of 19 high-risk and nine low-risk genotypes of human papillomavirus; the QuantPlex MTB/MDR/XDR for detecting Mycobacterium tuberculosis and resistance mutations associated with multiple and extensive drug resistant strains of the bacterium; and the QuantPlex STI-7 for detecting and differentiating seven sexually transmitted pathogens.
Though the qTOCE technology is platform agnostic, Seegene has validated the assays on Bio-Rad Laboratorie' CFX 96 System. It also has been validating qTOCE on Life Technologies' ABI 7500 System.
Though the firm has yet to receive US Food and Drug Administration clearance for any of its existing diagnostic products, Chun said that Seegene would pursue FDA approval for the assays. However, he didn't provide a timeline for when the firm expects to commercialize any FDA-cleared tests in the US.