Researchers from Institut Pasteur in France have developed a two-fold test to predict the cervical cancer risk in women with human papillomavirus (HPV).
HPV is known to be responsible for 99% of cervical cancers. The virus is linked to complicated diagnosis and treatment.
The new in-vitro molecular test, named HPV RNA-Seq, is designed to identify the type of HPV infection as well as any precancerous markers of high-grade squamous intraepithelial lesions (HSIL).
It is based on multiplexed reverse transcription PCR (RT-PCR) and next-generation sequencing (NGS).
Institut Pasteur Biology of Infection Unit Pathogen Discovery Laboratory lead investigator Marc Eloit said: “HPV RNA-Seq is a unique test that combines the advantages of molecular assays (HPV typing) and cervical cytology (cell phenotyping).”
The researchers tested HPV RNA-Seq in a proof-of-concept study involving samples from 55 women, including 28 with low-grade squamous intraepithelial lesions (LSIL) and 27 with precancerous HSIL.
Data showed that the new test detected and determined the type of HPV infection among a panel of 16 high-risk HPVs. The results were said to be comparable to a commonly used HPV DNA molecular diagnostic kit.
The researchers added that the new test identified two additional HPV-positive patients, compared to the DNA test, and also detected more patients with multiple HPV infections.
HPV RNA-Seq’s sensitivity in detecting the virus was 97.3%, with a negative predictive value of 93.8%.
The researchers further compared the test with a cytology method for cervical cancer triage. They observed markers of high-grade cytology and said that the new test demonstrated a favourable profile as a triage approach.
The the positive predictive value of HPV RNA-Seq compared to histology was also found to be always more than that of cytology versus histology.
HPV RNA-Seq is expected to offer quick results at low cost and also reduce unnecessary diagnostic procedures such as colposcopies.
According to the team, the test may also be used for other HPV-related cancers such as anal cancer and head and neck cancer.