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Spanish biotech company Bioiberica Farma launches the first DNA test that can predict the evolution of knee osteoarthritis

21 May 2013

A simple saliva analysis identifies genetic changes associated with rapid disease progressionPhysicians can identify patients having the worst prognosis, those that are at greatest risk of needing short-term prosthetic surgeryThis information allows physicians to design personalized treatments and influence the disease’s progression; reducing the need for prosthetic surgery and improving the patient’ quality of lifeA world first: this clinically tested, groundbreaking product has an excellent precision level (82%) and has been designed by Bioiberica Farma’s R&D team

Barcelona, May 21, 2013. This morning, Bioberica Farma, a Spanish bio-tech company specializing in osteoarthritis, presented the first genetic saliva test that predicts a patients’ predisposition to suffer rapid progression knee osteoarthritis.

It is a groundbreaking product that will allow physicians to identify those patients having the worst prognosis and who are at an elevated risk of needing prosthetic surgery in the short term. “Knowing that information is useful to design a personalized treatment for every patient and to control the disease’s progression in a more efficient way”, explained Dr. Josep Vergés, clinical pharmacologist and Medical and Scientific director of that company. He also added that “In this way, we will be able to delay the need for prosthetic surgery, thus improving the quality of life of OA patients”.

The test needs to be performed only once in a lifetime and consists of extracting a saliva simple from an OA patient. DNA is extracted and sent to a laboratory, where it is analyzed to search for genetic predisposition biomarkers for rapid progression osteoarthritis. The physician receives a laboratory report that classifies the patient according to four categories: minimum, low, medium or high genetic risk.

“These results will help physicians and patients alike to better understand the progression of the disease and act accordingly. If a patient is aware that his or her osteoarthritis will evolve rapidly, he will take more seriously non-pharmacological and pharmacological preventive measures, as well as his or her physician’ recommendations. Furthermore, he will have to be monitored more closely,” affirms Dr. Verges.

The test has an 82% precision, a level that it is considered “excellent” by the international statistical standards. “There is no other genetic test available that can predict knee OA progression. There are a number of low-precision products that can analyze susceptibility or risk of suffering many diseases, among them osteoarthritis. But these are genetic tests that only detect the presence or absence of certain biomarkers, they do not carry out a real clinical diagnosis-the presence or absence of certain biomarkers does not necessarily imply that the patient will ultimately develop that disease”, explained Dr. Vergés.

Development and scientific foundations
To develop this product, our research team carried out a four year multicenter clinical test that involved 281 primary knee OA patients, 31 Spanish healthcare centers and professionals from different fields (rheumatologists, trauma specialists physiotherapists and primary care physicians). The lead co-authors are Professor Francisco J. Blanco, rheumatologist at the Juan Canalejo University Hospital at A Coruña, Spain, and Dr. Josep Vergés himself.

Genetics play an important role in osteoarthritis (onset is hereditary in 40% of cases; progression is hereditary in 60-70% of cases). This is why the researchers’ main objective was to identify genetic biomarkers or SNPs (Single Nucleotide Polymorphisms) with significant association to rapid progression knee osteoarthritis.

Patients were classified into two prognostic groups: rapid progression/worst prognosis patients, and slow progression/best prognosis patients. DNA analysis allowed the identification of those SNPs associated with rapidly progressing OA. Then, a predictive mathematical model was developed. That model has been clinically validated in a second knee OA cohort and complies with the validity and usefulness standards of the United States’ National Institutes of Health. Last Friday, the clinical trial and the product were presented to the scientific community during the National Congress in Rheumatology of the SER (Spanish Society of Rheumatology) currently held in Tenerife. The international presentation of the product will continue in June, when it will be presented at the European Congress of Rheumatology, to be held in Madrid.

Bioibérica Farma, biotechnology company
The test has been developed by Bioiberica Farma’s R&D team. Bioiberica is a Spanish biotech company specializing in chondroprotector products for osteoarthritis and is the world’s leading non-Chinese heparin-exporting company. In 2012, we achieved a sales volume of €237 million, with exports representing some 69% of overall sales. Currently we have some 53 R&D projects under development.

For us, this product represents the entry into the area of personalized medicine. We realized some time ago that, in the medicine of the future, osteoarthritis patients will improve their quality of life through personalized medicine, and not only through pharmacological treatments,” stated José Escaich, Bioibérica’s CEO. “This new business line represents a strategic bid for our company, which we will progressively enlarge. Early in the next year, we will launch new products-new osteoarthritis biomarkers”, he added.

For its part, Montserrat Vendrell, Biocat’ general director (BIOCAT is the regional government body promoting biotechnology in Catalonia) welcomed the worldwide launching of a product designed by the R&D efforts of a Catalan company. “Nowadays, it is more important than ever that our companies reinforce their ability to compete in the international markets, selling locally designed innovative products. It is also key that companies such as Bioiberica and others belonging to the Catalan bio cluster do not content themselves with a specific share of the market –in Bioibérica’s case, the production of heparin and osteoarthritis drugs- and commit themselves to R&D, taking the risk of researching new developments in personalized medicine”.

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