15 Aug Cervical Cancer: New HPV RNA-Seq Test Diagnoses Riskiest Forms of HPV Infection
MedicalResearch.com Interview with:
Marc Eloit, D.V.M, Ph.D.
Pathogen Discovery Laboratory, Biology of Infection Unit,
MedicalResearch.com: What is the background for this study?
Response: Human papillomaviruses (HPV) are responsible for >99% of cervical cancers. Currently, cervical cancer screening either focuses on testing for the presence of HPV or identifying abnormal cervical cells with cytology (Pap test). However, molecular diagnostic tests based on the detection of viral DNA or RNA have low positive predictive values for the identification of cancer or precancerous lesions, and analysis of cervical cells with the Pap test, even when combined with molecular detection of high-risk HPV, results in a significant number of unnecessary colposcopies.
We have developed HPV RNA-Seq, a new “two-for-one” molecular diagnostic test that not only detects the type of HPV, but also identifies precancerous markers. This test is therefore designed to diagnose the riskiest forms of HPV infection, provide rapid results at moderate cost, and helps avoiding unnecessary diagnostic procedures.
HPV RNA-Seq is based on the dual combination of multiplexed reverse transcription PCR (RT-PCR) and next-generation sequencing (NGS). RT-PCR is a sensitive way to detect small amounts of RNA, the genetic material that reflects the activity of the HPV genes, and NGS finely characterizes the amplified viral sequences. This enables detection of up to 16 high-risk or putative high-risk HPV in a sample as well as the presence of precancerous markers.
MedicalResearch.com: What are the main findings?
Response: In this proof-of-concept study, HPV RNA-Seq was used to analyze samples from 55 patients, 28 with low-grade squamous intraepithelial lesions (LSIL) and 27 patients with high-grade squamous intraepithelial lesions (HSIL), which is a precancerous stage of the cervix. HPV RNA-Seq was able to identify the type of HPV with results comparable to an officially approved HPV DNA molecular diagnostic kit. HPV RNA-Seq also detected molecular markers of high-grade cytology, with encouraging diagnostic performances as a triage test. We found that the positive predictive value of HPV RNA-Seq vs. histology (which is considered the gold standard for cervical cancer diagnosis) was greater than the positive predictive value of cytology vs. histology.
MedicalResearch.com: What should readers take away from your report?
Response: HPV RNA-Seq is a unique test that combines the advantages of molecular assays (HPV typing) and cervical cytology (cell phenotyping).
HPV RNA-Seq can provide a second-line test in HPV-positive patients to reduce unnecessary colposcopies and even be used as a two-for-one test combining HPV typing with triage capabilities. The procedure is minimally invasive and is convenient for sample conserved at room temperature.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The assay will now require further clinical validation in larger cohorts with the support of industrial partnerships in order to reach the market.
Disclosures: The Institut Pasteur, Paris, France, granted this work. The authors have submitted patent application covering the findings of this work.
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