Detecting High Risk HPV types in Cervical Lesions

Novel HPV risk classification method utilizing amino acid sequence/mutations in E6 protein as a marker


  • Enables precise risk classification of HPV, surpassing the accuracy of conventional methods.
  • Expected to refine treatment strategies, including follow-up durations during pre-cervical cancer stages or surgical interventions, thereby alleviating patient burden and reducing medical expenses.

Technology Overview & Background

Human papillomavirus (HPV) infection is known as a cause of cervical cancer and, more recently, mid-pharyngeal cancer. With over 200 genotypes identified, epidemiological studies categorize HPV into high-risk and low-risk types based on the detection of cancer. On the other hand, more than 30 genotypes have been unclassified. HPV testing for cervical cancer screening has increased in Japan. However, existing commercial tests based on the L1 gene sequence of HPV for risk classification, which is considered it does not completely align with epidemiological risk assessments as a problem. In addition, L1 is a capsid-constituting protein, and surface proteins are unlikely to be involved in oncogenesis.

This study focuses on the nucleotide and amino acid sequences and mutations in E6 protein of HPV, which is a protein that supports the survival and proliferation of cancer cells and is known to be strongly associated with carcinogenesis to identify a biomarker with robust predictive value.

Cervical dysplasia, the precursor to cervical cancer, is categorized into mild (CIN1), moderate (CIN2), and severe (CIN3) dysplasia based on the abnormal cellular changes. Although high-risk HPV infection can lead dysplasia, cases of CIN1 and CIN2 often undergo surveillance rather than immediate treatment due to potential spontaneous resolution. Accurate risk classification through this method holds promise for enhancing follow-up protocols for CIN1 and CIN2 cases and improving the evaluation of unclassified HPV strains.


  • Researchers classified HPVs based on specific amino acid sequences in the consensus E6 gene sequence, correlating phenylalanine, arginine or lysine, tyrosine or leucine, and leucine at positions 34, 40, 102, and 120, respectively, as high-risk types. This classification aligns with epidemiological risk assessments by Munoz et al. (2003).
  • Classification of HPV70 and HPV73 according to the L1 gene sequence are different from clinical classification. The researcher’s proposed classification based on E6 protein amino acids was consistent with epidemiological risk classifications.
  • Risk classification using the proposed method on cervical swab specimens (n=325) demonstrated correlation with clinical outcomes (recovery or non-recovery).


  • Niiya et al., Journal of Medical Virology. 2023 Aug;95(8): e29049. doi: 10.1002/jmv.29049.


  • Applied (Unpublish)

Principal Investigator & Academic Institution

Prof. Koh-ichiro YOSHIURA (Department of Human Genetics, Nagasaki University Graduate School of Biomedical Sciences)


TECH MANAGE CORP. is looking for a diagnostic company that is interested in licensing this invention for commercialization on behalf of the University. We can also arrange a meeting with the PI of this invention. Please feel free to contact us with any requests you may have.





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