Molecular diagnostic technologies developer, Seegene, has developed a new genotyping assay, the QuantPlex HPV28 assay.
Based on real-time PCR quantitative TOCE-CCMTA technology, QuantPlex HPV28 is designed for the detection, genotyping and quantification of 19 high-risk and nine low-risk genotypes of the human papilloma virus (HPV) that are directly associated with cervical, genital area and oropharyngeal cancers.
Multiple studies suggest that quantification of viral burden has proven to be the correct treatment for patients, as molecular testing for the presence and type of HPV became critical when utilised with cytology, especially for neoplasia grade 2 or higher (CIN 2+).
Along with a linkage between changes in viral burden and cytological abnormalities, studies have shown a link between viral burden and CIN grade.
The company claims that the correlation between infection and cancer and a plethora of HPV types, make HPV testing effective and efficient care for patients.
The direct link between HPV and cervical cancer has been well established and persistent infections with specific strains of HPV can lead to the development of malignant lesions.
In addition, evidence suggests that the determination of viral burden in a malignant lesion can be a valuable prognostic indicator of abnormalities.
Seegene founder CTO and CEO, Jong-Yoon Chun, said: "As a highly multiplexed molecular assay 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 personalised treatments for their patients."
The test is likely to be released during the third quarter of 2012.