Genomic Vision is Accelerating Its Clinical Trial in Cervical Cancer with an Additional Study in the Czech Republic

Regulatory News:

Genomic Vision (Paris:GV) (FR0011799907 – GV), DNA molecular combing specialist that develops tests for the diagnostics market and tools for the life sciences research market, today announces the first enrollments in the clinical trial being organized in the Czech Republic aimed at validating the integration of the oncogenic, i.e. high-risk, human papillomavirus (HPV-HR) as an indicator of the severity of cervical lesions.

This trial is being undertaken in two major hospitals, the Brno Centre for Outpatient Gynaecology and Primary Care (Dr. Vladimír Dvorák) and the Brno University Hospital (Prof. Pavel Ventruba), and foresees the inclusion of 993 female patients. The primary end-point of this study is to prove that the integration of HPV is a biomarker for diagnosing high-risk precancerous lesions that require appropriate treatment to be defined. The initial results of this pilot study are expected in early 2017.

Aaron Bensimon, Genomic Vision’s co-founder and Chairman, comments: "We wanted to launch this study simultaneously with the IDAHO trial, currently being undertaken with Reims University Hospital and other French medical centers, in order to accelerate and internationalize our HPV test development program. Indeed, following feedback from clinicians, it is clear that there is a real need for more specific diagnostic tests capable of detecting high-grade precancerous lesions that are likely to evolve into cancerous lesions in the cervix. Thanks to a high enrollment pace, the initial results of this study will be available by the beginning of 2017.”

The integration of HPV DNA in a host’s genome is considered to be a key event in the progression of precancerous lesions into cancerous lesions in the cervix. The aim of this study is to determine whether the integration of HPV-HR DNA in patients’ genomes is a sufficient indicator of diagnostics, i.e. of the severity of lesions. Genomic Vision’s molecular combing technique is currently the only one that allows the frequency of the integration of high-risk HPV-HR to be detected, in a direct and high resolution manner.

Dr. Dvorák, Head Physician at the Brno Centre for Outpatient Gynaecology and Primary Care, and principal investigator for the study, adds: "HPV infection, which is in some cases related to cervical cancer, is one of main threats to women´s health. Every improvement in diagnostics is very important, as it can influence the treatment program for each individual patient. For these reasons, I have agreed to participate in the HPV trial organized by Genomic Vision. Should its positive results be confirmed, physicians will have access to a new tool enabling them to more accurately predict the severity of HPV infection with regard to the development of cervical cancer.”

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ABOUT GENOMIC VISION

Founded in 2004, Genomic Vision is a DNA molecular combing specialist that develops tests for the diagnostics market and tools for the life sciences research market. Using its innovative technology that allows the direct visualization of individual DNA molecules, Genomic Vision detects quantitative and qualitative variations in the genome that are at the origin of numerous serious pathologies. The Company is developing a solid portfolio of tests that initially target breast and colon cancers. Since 2013, the Company has marketed the CombHelix FSHD test for identifying facioscapulohumeral dystrophy (FSHD), a myopathy that is difficult to detect. It is marketed in the United States through a strategic alliance with Quest Diagnostics, the American leader in diagnostic laboratory tests, and in France directly by the Company. Genomic Vision has been listed on Compartment C of Euronext Paris since April 2014.

ABOUT MOLECULAR COMBING

DNA molecular combing technology significantly improves the structural and functional analysis of DNA molecules. DNA fibers are stretched over glass slides, as if "combed", and uniformly aligned over the entire surface. It is then possible to identify genetic anomalies by locating specific genes or sequences in the patient's genome using genetic markers, a technique developed by Genomic Vision and patented under the name Genomic Morse Code. This exploration of the entire genome at high resolution via a simple analysis enables the direct visualization of genetic anomalies that are undetectable by other technologies.
For further information, please go to: www.genomicvision.com

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