Genomic Vision & Reims University Hospital Launch Clinical Study to Establish New Screening Tool for Early Detection & Preven...
14 Décembre 2015 - 5:45PM
Business Wire
The Largest Study ever Undertaken Using the
Molecular Combing Technique on 3,500 Patients at 11 French
Hospitals
Regulatory News:
Genomic Vision (Paris:GV), a molecular diagnostics company
specializing in the development of diagnostic tests for genetic
diseases and cancers based on molecular combing technology, today
announces that it has signed a partnership agreement with the
Reims University Hospital (CHU de Reims) for a clinical
study aiming to validate the integration of the high-risk human
papillomavirus (HPV-HR) as an appropriate indicator of the
progression of cervical lesions towards cervical cancer. This
prospective multicenter study, called IDAHO (Intégration de l’ADN
des HPV Oncogènes, or integration of oncogenic HPV DNA), will
involve 3,500 patients to be treated at 11 leading French
gynecology hospitals.
HPV-HR DNA is the only independent risk factor for cervical
cancer, which is the second most common form of cancer in women,
behind breast cancer. Every year, almost 500,000 new cases and
between 250,000 and 300,000 deaths are recorded worldwide. Due to
its slow progression, cervical cancer can be prevented through
screening and the treatment of precancerous lesions.
This study aims to validate the integration of HPV-HR DNA in
patients’ genomes as an indicator of the severity of cervical
lesions. This indicator will also help identify lesions presenting
a high risk of developing cervical cancer. Genomic Vision’s
molecular combing technique is currently the only one that allows
direct and high-resolution visualization of the integration of
high-risk HPV genomes, as shown by the data presented by the
Company at the 29th International Papillomavirus Conference &
Clinical Workshop in Seattle (see the press release of August 25,
2014).
Thus far, screening has been essentially based on cervical
smears and tests to detect viral RNA or DNA (HPV tests). Cervical
smears are not sensitive enough while HPV tests, which are highly
sensitive, are not sufficiently specific. These tests result in
unnecessary, invasive and expensive clinical examinations, as well
as excessive treatments that can have detrimental effects on the
future pregnancies of these women, who are often young.
“The goal of the IDAHO study is to overcome this diagnostic
insufficiency 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,” explains Professor
Olivier Graesslin, M.D., Head of the Reims University Hospital’s
Gynecology-Obstetrics unit and coordinator of this study.
The IDAHO study will comprise two phases:
- The first, cross-sectional phase, will
involve the recruitment of 3,500 patients for 3 years beginning in
December 2015 with an aim to show that the integration of HPV is a
biomarker for diagnosing high-risk precancerous lesions that
require immediate care and treatment.
- The second phase will follow patients
who have tested positive for HPV infection with low-grade
precancerous lesions for three years, in order to confirm that the
integration of HPV DNA is a biomarker for the progression of
precancerous lesions.
Aaron Bensimon, Ph.D., Genomic Vision’s co-founder and
Chairman, concludes: “This clinical study involving 11 leading
French hospitals is the largest one that Genomic Vision has
participated in, and reflects the medical community’s need for the
development of more efficient cervical cancer screening tests. The
quality of this consortium’s partners makes us particularly
optimistic regarding the outcome of our collaboration. Once it has
been validated, our HPV test should increase the efficacy of the
diagnosis and thus enable patients to be steered towards the most
suitable treatment, therefore avoiding the need for unnecessary,
invasive and expensive colposcopies.”
Upcoming financial publication
- Annual Revenue for 2015, Monday,
January 18, 2016* (after trading)
* indicative date, which may be subject to
change
ABOUT GENOMIC VISIONFounded in 2004, Genomic Vision is a
molecular diagnostics company that specializes in the development
of diagnostic tests for genetic diseases and cancers based on
molecular combing. Using this 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 COMBINGDNA 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
ABOUT THE REIMS UNIVERSITY HOSPITALIn keeping with public
service values, the Reims University Hospital (“Centre Hospitalier
Universitaire de Reims”, or “CHU de Reims”) strives to meet one
goal: to provide, through its 15 medical departments, excellent
care and high-quality treatment to all patients in the
Champagne-Ardenne region of France.The Reims University Hospital
also works hard to maintain its positioning as a university
hospital and to promote the involvement of its medical staff in
innovative research projects.Professor Christine Clavel and Doctor
Véronique Dalstein, molecular biologists in the Reims University
Hospital’s Biopathology laboratory, have for many years been
involved in research into HPV infections and use of the HPV test in
clinical practice, notably in cervical cancer screening. This area
of research is part of the Eastern France Cancer Research Cluster’s
virus and cancer focus. Their research work in this field has
received domestic and international acclaim.
For further information, please go to: www.chu-reims.fr
Member of CAC® Mid & Small, CAC®
All-Tradable and EnterNext© PEA-PME 150 indexes
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version on businesswire.com: http://www.businesswire.com/news/home/20151214005985/en/
Genomic VisionAaron BensimonCo-founder, Chairman &
CEOTel.: +33 1 49 08 07
50investisseurs@genomicvision.comorLHAInvestor Relations
USAnne Marie Fields, SVPTel.:
212-838-3777afields@lhai.comorNewCapInvestor Relations
/Strategic CommunicationsDušan Orešanský / Emmanuel HuynhTel.: +33
1 44 71 94 92gv@newcap.frorReims University HospitalJulie
CollinPR ManagerTel.: +33 3 26 78 34 38jcollin@chu-reims.fr
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