A Real-Time Multiplex Quantification Assay For Respiratory Diseases Introduced

Seegene Inc. has announced the development of a new molecular assay for the quantification of twenty-one respiratory viral pathogens associated with respiratory disease. QuantPlex RV-16 Assay will give physicians the specific information needed to guide patient treatment decisions.

Acute respiratory disease is a serious source of infection around the world. The majority of respiratory infections (approximately 80%) are viral in nature. Accurate and reliable detection and differentiation of these respiratory viral pathogens is needed to assess and treat a patient's particular disease state.

Conventional detection methods for respiratory viral pathogen detection include rapid point-of-care immunoassays and cell culture in combination with direct immunofluorescence assays. With the 2009 H1N1 pandemic, nucleic acid detection methods have started to become the accepted standard for the diagnosis of respiratory viral infections. Comparative studies have shown that for the detection of respiratory viruses, real-time Reverse Transcriptase - Polymerase chain Reaction (RT-PCR) is significantly more sensitive and specific than certain conventional detection methods. Current commercially available RT-PCR detection assays for respiratory viruses, however, can only provide qualitative information and are limited in their ability to distinguish between current infections and the shedding of low concentrations of virus from previous infections.

In contrast, a quantitative real-time RT-PCR respiratory viral assay provides both a qualitative answer, as well as quantitative information concerning each analyte detected. The advantages of a quantitative real-time RT-PCR respiratory viral assay is that it permits the assessment of pathogen load at a given point in time, facilitates the monitoring of response to treatment, and offers the ability to determine the dynamics of the viruses proliferation.

Studies have shown that the virus type and viral load can influence the clinical characteristics of an infection. In addition, studies have shown that viral single infections and co-infections as well as viral load contribute to disease severity in children with respiratory tract infections. Studies have also shown that under specific conditions clinical improvement is associated in respiratory viral infections with a reduction in viral burden.

Furthermore, quantitative tests can aid in the study of a respiratory viral pathogenesis, aid the development of vaccines, assist in the development of treatment strategies, and can facilitate investigations into the significance of respiratory viral infections when there are singular viral or multiple viral infections involved.

Seegene's breakthrough technology is able to quantify multiple targets in a multiplexed molecular real-time PCR format. The QuantPlex RV-16 Assay can detect, differentiate and provide quantitative information for adenovirus, influenza A and B, parainfluenza virus types 1/2/3/4, rhinovirus types A/B/C, respiratory syncytial viruses A and B, bocavirus 1/2/3/4, metapneumovirus, coronavirus types 229E, NL63, OC43 and enterovirus from a single sample, all in real-time.

"The QuantPlex RV-16 Assay represents a new class of quantitative molecular tests that are multiplexed. Multiplex Quantification of viral load by real-time PCR will facilitate a better understanding of viral pathogenesis and will provide information to allow true patient specific personalized care," said Dr. Jong-Yoon Chun, Founder, CTO and CEO of Seegene. "Moreover, respiratory viral load quantification contributes to the rapidly growing field of diagnostic molecular virology, as well as advances the interpretation of real-time PCR results in various clinical contexts. Using these types of tests, clinicians will be able to expand the questions that can be asked about a patient's illness, thereby enhancing the physicians' ability to provide accurate and data driven decisions for their patients."

The QuantPlex RV-16 Assay is based on Seegene's proprietary TOCE-CCMTA technology, a High Multiplex real-time quantitative PCR technology that enables the simultaneous detection, differentiation and quantification of up to 20 analytes on an existing 4-color real-time instrument.