Seegene Inc. announced the development and commercialization of the first molecular assay for the detection, genotyping and quantification of nineteen high-risk and nine low-risk genotypes of the Human Papilloma virus (HPV). Seegene's breakthrough new test, QuantPlex™ HPV28 Genotyping Assay, will provide physicians with accurate HPV genotypes and quantification for nineteen high-risk and nine low-risk genotypes that are directly associated with cervical, genital area and oropharyngeal cancers. Release of the kit is anticipated for the third quarter of this year.
Persistent infections with specific strains of HPV can lead to the development of malignant lesions, and the direct link between HPV and cervical cancer has been well established. To date over 100 HPV types have been identified, of which approximately 40 are sexually transmissible. HPV types 16 and 18 have been associated with approximately 73% of invasive cervical cancers and approximately 10% of cases studied were co-infections of HPV types.
The plethora of HPV types and the correlation between infection and cancer make accurate HPV testing and typing a critical component of effective and efficient patient care. Multiple studies have shown that the molecular testing for the presence and type of HPV is critical when utilized with cytology, especially for neoplasia grade II or higher (CIN 2+).
Furthermore, quantification of viral burden at the time of testing, and over time, has proven to be critical in the determination of applying the correct treatment for the patient. Studies have consistently shown a link between viral burden and CIN grade along with a linkage between changes in viral burden and cytological abnormalities. In addition, evidence suggests that the determination of viral burden in a lesion can be a valuable prognostic indicator of abnormalities.
Nucleic acid-based methods, direct probe and signal amplification methods, such as PCR, are the most common and most sensitive detection approaches. PCR-based testing for HPV usually include a second post-detection and typing technique, such as solid phase hybridization. Limitations of these methods are either related to the inherent complexity of the systems or the relative long time to a result.
"As a highly multiplexed molecular assays capable of rapidly detecting and quantifying specific infections, our QuantPlex™ HPV28 Genotyping Assay will help improve clinical outcomes by providing physicians with the information they need to develop personalized treatments for their patients," said Dr. Jong-Yoon Chun, Founder, CTO and CEO of Seegene.
The QuantPlex™ HPV28 Genotyping Assay is based on TOCE™-CCMTA technology, a high multiplex real time quantitative PCR technology that allows the simultaneous detection, differentiation and quantification of up to 20 analytes on an existing 4-color real time instrument. This breakthrough technology can provide new and existing life science companies with a competitive edge in a wide range of molecular testing applications and industry sectors.