Integrating the human papilloma virus’ DNA into a patient’s genome could serve as a diagnostic biomarker to identify precancerous cervical lesions that are at a high risk for progressing to cancer.
Paris-based Genomic Vision, a company that develops cancer diagnostic testing, DNA replication, and biomarkers, launched the EXPL-HPV-002 clinical trial to evaluate high-risk HPV “integration” as an indicator of precancerous cervical lesions in July 2016.
The company recruited 300 women ages 25-65 to participate in the study, of which initial results come from 126 of these patients. Through a process called molecular combing, researchers found that the integration of 14 high-risk HPV were appropriate for identifying high-risk precancerous cervical lesions that require clinical care.
“These first results demonstrate the suitability of the molecular combing in order to improve the early diagnosis of cervical cancer. The clinical demonstration of the HR-HPV integration as progressive key factor towards the disease highlights a very strong prognostic value. We look forward to confirming these promising data on the whole cohort of patients,” Vladimír Dvořák, MD, lead physician at the Brno Centre for Outpatient Gynaecology and Primary Care in the Czech Republic, said in a recent news release.
The Czech Republic’s Brno University Hospital also is participating in the study.
In Genomic Vision’s molecular combing process, DNA molecules are stretched onto a specially treated glass surface, where sequences of interest can be labeled to help detect DNA rearrangements. The process is a new approach to cervical cancer detection, says the company, which also develops diagnostic tests for breast, ovarian, and colorectal cancers, and myopathies.
“The HPV infection, at the origin of the cervical cancer in certain cases, is one of the major threats for women’s health. We know that adapted care through an early diagnosis of the disease significantly increase the life expectancy,” Aaron Bensimon, Genomic Vision’s co-founder and CEO, said. “The interim collected data of the EXPL-HPV-002 study are extremely encouraging and need to be replicated in the future on a larger number of patients. The accurate analysis of the final results expected by the end of the year should allow to position our technology as a new standard for premature detection of this cancer, 3rd most wide-spread within female population at the origin of 275.00 deaths a year.”