NEW YORK (GenomeWeb) – French molecular diagnostics company Genomic Vision has teamed up with Reims University Hospital to develop a new screening tool for the early detection and prevention of cervical cancer, the company announced today.
Using Genomic Vision's molecular combing technique, the company and the hospital will conduct a clinical study of 3,500 patients at 11 hospitals in France with the aim of validating the integration of high-risk human papillomavirus DNA in patient genomes as an indicator of whether certain cervical lesions could progress to cancer, Genomic Vision said in a statement.
The company's molecular combing technique involves stretching and uniformly aligning DNA fibers over glass slides and then exposing the molecules to fluorescent probes to identify amplifications, repeats, deletions, and other anomalies.
Molecular combing is the only technique that allows for direct and high-resolution visualization of high-risk HPV genomes, the company said in a statement.
The study — called IDAHO (Intégration de l’ADN des HPV Oncogènes, or integration of oncogenic HPV DNA) — will be completed in two phases. The first phase will aim to show that integration of HPV is an accurate biomarker for determining which precancerous lesions are high risk and require immediate treatment. The second phase will follow patients with low-risk lesions for three years to confirm that the integration of HPV DNA can indeed successfully separate high-risk lesions from low-risk lesions.
"The goal of the IDAHO study is to overcome this diagnostic insufficiency [of cervical smears and HPV tests] by identifying a biomarker that can specifically differentiate between women with a high risk of developing cervical cancer, and who therefore require treatment, and women with a low risk who require appropriate monitoring," said Olivier Graesslin, Reims University Hospital's head of gynecology and obstetrics, in a statement.
Earlier this month, Genomic Vision also partnered with European genetic research organization University-Hospital Institute Imagine, to develop genetic tests based on molecular combing to identify diseases caused by genetic structural variations.