First Oryzon product on the market, a non-invasive test to detect endometrial cancer
They are one of the few biotechnology firms in the country that has been able to market one of their own products, which is the fruit of a joint venture with Laboratorios Reig Jofré.
The results of the clinical study on what will be Oryzon’s first self-developed product on the market will be presented this week. It is called GynEC-Dx, a new system for early detection of uterine cancer that they have developed jointly with Laboratorios Reig Jofré, which is expected to launch to market in January 2012.
According to the conclusions of this multicenter clinical study carried out in 16 Spanish hospitals under the supervision of the groups headed by Dr. Jordi Ponce, of Bellvitge Hospital, and Dr. Antonio Gil, of Barcelona’s Vall d’Hebron University Hospital, presented at the 17th Biannual Meeting of the European Society for Gynecological Oncology (ESGO), GynEC-Dx allows doctors to rule out tumor presence in 97% of patients with just one uterine-aspirate sample, thus avoiding biopsies and hysteroscopies.
With endometrial cancer, the most frequent tumor in Spanish women behind breast cancer, there are two fundamental problems: the difficulty of early detection of all cases and the uncomfortable process of diagnostic tests, which are generally done through biopsy or hysteroscopy. The new detection system developed by Oryzon, under the name GynEC-DX, provides a solution to both problems.
The cell samples can be obtained “through uterine aspirates using a small cannula without anesthesia in the gynecologist’s office, making the process much more comfortable for the patient,” explains Oryzon CEO Carlos Buesa. The main symptom of this cancer is abnormal uterine bleeding, but in some perimenopausal women it is more difficult to suspect this type of tumor, given that many women often experience irregularities in the menstrual cycle at this time of their life. According to Carlos Buesa, “there are 60,000 new cases of endometrial cancer diagnosed each year in Europe, and more than 300,000 in the world. In Spain, some 30,000 perimenopausal or postmenopausal women could benefit from this test in order to rule out or confirm the presence of endometrial cancer.”
Marketing GynEC-Dx will be a very important milestone for Oryzon, which was founded in 2000, “as it will be the first product developed by the company to go to market, a goal that very few Spanish biotechnology companies have achieved so far. With this step, we will join that exclusive group and reinforce even further our position as one of the most competitive companies in Spain and the world,” points out Buesa.
Right now, Oryzon is “exploring a number of models to launch this product internationally and is currently in talks with various multinational companies in the diagnostics sector. We have also applied for the in vitro diagnostics healthcare product manufacturer license from the Spanish Drug Agency.” Furthermore, Carlos Buesa also explains that “we are optimistic about the possibility of including this test, if the Ministry of Health admits it, as part of the public healthcare services, as it would improve diagnostics, reduce current costs for diagnosing uterine cancer, lower wait times and cause the patient less discomfort and concern.”
The partner, Reig Jofré
GynEC-Dx is the result of a research project initiated in 2006 through the joint venture established between Oryzon and Laboratorios Reig Jofré with the creation of Geadic Biotec AIE and an investment of nearly €4 millions, which included a subsidy from the Government of Catalonia through ACC1Ó in their 2007 Nuclis d’Innovació program.
Scientists from both companies and researchers at Vall d’Hebron Hospital initially identified a group of markers that in the right combination could identify patients with endometrial cancer using a uterine-aspirate sample, with a high level of sensitivity and specificity. These results were patented and published in the International Journal of Cancer.
Later, they began a double-blind, multicenter clinical study in 16 Spanish hospitals with more than 500 patients, led by the groups of Dr. Jordi Ponce and Dr. Antonio Gil, who presented the results at the meeting of the European Society for Gynecological Oncology held this week in Milan.
Other launches in progress
Another project that will also come to fruition soon is the launch of a second product, in this case to detect bladder cancer using a urine sample: Cxbladder. In fact, just before summer, the biotech company announced the signing of an agreement with Pacific Edge Ltd. of New Zealand, giving Oryzon the exclusive license to market this product in Spain and Portugal.
With this, the company is fleshing out its franchise of early detection diagnostic products, “which we market in collaboration with our partners and analyze the results of right here in our clinical genetics lab, accredited by the Government of Catalonia and the core of our diagnostics and personalized medicine division,” explains Carlos Buesa. “We have shown that our biomarker-identification platform is able to develop products for personalized medicine and take them to market. Our goal is to become leaders in the Spanish diagnostic sector.”
Oryzon has one of the most complete biomarker-technology platforms in Europe. Highly specialized in genomics, proteomics and bioinformatics, the company can quickly identify differential clinical markers for various illnesses. These technology platforms have allowed Oryzon to position itself as a company with a strong presence in the clinical diagnostics arena. They also have a strong biomarker-validation platform that uses technology like RNAi, antibody and protein arrays (Flexarray-Scienion), characterization (Biacore Flexchip) and transformation in therapeutic products through their phage display platform and their structural genomics platform with a fragment screening approach (NMR and x-ray crystallography).