And..., after 5 years of hard work and heavy investments, our dream came true!. We got ready our first product GynEC®-DX, a new diagnostic test for the early detection of endometrial cancer (EC). We are happy because this product will help patients and doctors to deal with a life threatening disease. But on top, this achievement also demonstrates that the technological platform from Oryzon is highly competitive and validates our business model.
EC is the 4th cancer indication in women in Europe and the 1st of the gynecological cancer (88.000 cases/year in Europe and near 300.000 in the world). 22.000 women in Europe die per year due to endometrial cancer. According to KOLs, there are two main problems with endometrial cancer, the most frequent tumour among women in Spain after breast cancer: the difficulty in detecting all cases at an early stage and the discomfort, costs and risks associated with the diagnostic tests, generally involving invasive procedures as hysteroscopy.
The new detection system developed by Oryzon, jointly with Reig Jofré Laboratories, a brave Spanish medium size pharma company, under the name GynEC®-DX, provides a solution to both problems. We estimate that, worldwide, more than 3000.000 women could bennefit of this early detection product.
GynEC®-DX uses a gene-expression fingerprint to diagnose endometrial cancer on uterine aspirates. GynEC®-DX is a Product based on RT-PCR analysis performed on a Roche Platform and a bioinformatic analysis (specific algorithm) in a signature of 5 genes.
The product is protected with an International Patent and is launched on the Spanish market in the next weeks.
We had reported last year on the performance of GynEC®-DX on a scientific paper (that was chosen for the cover page of the printed issue of the International Journal of Cancer). But the definitive performance of the product was demonstrated in a multi-centric double blind prospective clinical trial conducted in 14 Spanish hospitals under the supervision of Dr. Jordi Ponce, at Bellvitge Hospital, and Dr. Antonio Gil, at the Vall d’Hebron Universitary Hospital in Barcelona, GynEC®-DX allows the presence of tumour to be ruled out in 97% of cases through a sample of uterine aspirate, thus allowing a better assessment of whether further analysis as biopsies and hysteroscopies are indicated. When combined with traditional biopsy the negative predictive value is 99,6%.
In the mean time, Oryzon got also the accreditation as Centralized Human Diagnostic Lab from the Catalan Government and the Manufacturing License for an in vitro health-care diagnostic product by the Spanish Drug and Medical Devices Agency (AEMPS).
GynEC®-Dx will be commercialized first directly in Spain together with laboratories Reig-Jofré and we expect to find soon an international partner for markets abroad. We believe that this product together with others to be launched in 2012 will change our company on a definitive way.
Years of hard work deserved it...!
EC is the 4th cancer indication in women in Europe and the 1st of the gynecological cancer (88.000 cases/year in Europe and near 300.000 in the world). 22.000 women in Europe die per year due to endometrial cancer. According to KOLs, there are two main problems with endometrial cancer, the most frequent tumour among women in Spain after breast cancer: the difficulty in detecting all cases at an early stage and the discomfort, costs and risks associated with the diagnostic tests, generally involving invasive procedures as hysteroscopy.
The new detection system developed by Oryzon, jointly with Reig Jofré Laboratories, a brave Spanish medium size pharma company, under the name GynEC®-DX, provides a solution to both problems. We estimate that, worldwide, more than 3000.000 women could bennefit of this early detection product.
GynEC®-DX uses a gene-expression fingerprint to diagnose endometrial cancer on uterine aspirates. GynEC®-DX is a Product based on RT-PCR analysis performed on a Roche Platform and a bioinformatic analysis (specific algorithm) in a signature of 5 genes.
The product is protected with an International Patent and is launched on the Spanish market in the next weeks.
We had reported last year on the performance of GynEC®-DX on a scientific paper (that was chosen for the cover page of the printed issue of the International Journal of Cancer). But the definitive performance of the product was demonstrated in a multi-centric double blind prospective clinical trial conducted in 14 Spanish hospitals under the supervision of Dr. Jordi Ponce, at Bellvitge Hospital, and Dr. Antonio Gil, at the Vall d’Hebron Universitary Hospital in Barcelona, GynEC®-DX allows the presence of tumour to be ruled out in 97% of cases through a sample of uterine aspirate, thus allowing a better assessment of whether further analysis as biopsies and hysteroscopies are indicated. When combined with traditional biopsy the negative predictive value is 99,6%.
In the mean time, Oryzon got also the accreditation as Centralized Human Diagnostic Lab from the Catalan Government and the Manufacturing License for an in vitro health-care diagnostic product by the Spanish Drug and Medical Devices Agency (AEMPS).
GynEC®-Dx will be commercialized first directly in Spain together with laboratories Reig-Jofré and we expect to find soon an international partner for markets abroad. We believe that this product together with others to be launched in 2012 will change our company on a definitive way.
Years of hard work deserved it...!
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