Can A New Test Better Predict Cervical Cancer in HPV-Positive Women?

French researchers have developed a test capable of predicting the risk of cervical cancer in women with human papillomavirus (HPV). The findings were published in The Journal of Molecular Diagnostics.

In this proof-of-concept study, researchers developed a broad-range detection test of HPV transcripts capable of taking a snapshot of 16 high-risk or reputed high-risk HPV panels in cervical lesions. This novel molecular assay, named HPV- RNA-Seq, was developed to detect and record HPV-positive samples while determining a combination of HPV reads at specific viral intervals that can better reflect the presence of any precancerous cells.

The testing was conducted on 55 patients, all women between the ages of 25 and 65, who were referred for colposcopy consultations at French hospitals based a low-grade squamous intraepithelial lesion (LSIL) or high-grade squamous intraepithelial lesion (HSIL) result on their cytology test. Following written consent from the subjects, the researchers aggregated data based on date and results of cytology tests, age at the time of the cytology test, the date and results of all available histologic results subsequent to colposcopy. Biopsies were only recorded in cases of abnormal colposcopies.

Test May Yield Significant Clinical Benefits

The results of the study suggest encouraging diagnostic efficacy of this assay as a triage test, as HPV RNA-Seq was shown to detect papillomaviruses with performances comparable to a widely used HPV reference molecular diagnostic kit, and that a combination of the number of sequencing reads at specific early versus late HPV intervals can be utilized to identify high-grade cytology. “HPV RNA-Seq will be further developed and validated as a companion test in HPV DNA-positive patients or when the result of cytology is uncertain, to allow focusing the colposcopies to the most relevant patients,” the study authors wrote in a discussion of their findings.

“It has recently been shown that only one third of women recommended for colposcopy after primary HPV testing (DNA) and cytology actually had HSIL. By increasing the positive predictive value in detecting HSIL, HPV RNA-Seq could significantly increase the medical benefit/cost ratio of colposcopies.”

The authors added that “HPV RNA-Seq can provide a second-line test in HPV-positive patients to reduce unnecessary colposcopies and even be used as a two-in-one test combining HPV typing with triage capabilities. HPV RNA-Seq is minimally invasive and is convenient for sample conserved at room temperature. The assay will now require further clinical validation in larger cohorts.”