Berlin, Germany, and Madrid, Spain, October 29, 2014: SCIENION AG and GENOMICA S.A.U announced today the launch of multiplex CE-IVD tests for sexually transmitted infections (STIs), CLART® STI A&B.
According to recent estimates, the global incidence rate for curable STI infections per year, such as those with Treponema pallidum (Syphilis), Neisseria gonorrhoea (Gonorrhea), Chlamydia trachomatis and Trichomonas vaginalis (Trichomoniasis), is about 340 million cases. Aside from implications for patients, that may depend on treatment protocols established by the different countries, these infections and their after-effects represent an enormous burden for healthcare and economic systems worldwide.
Reliable, efficient and unified diagnostic tools are essential for the control and prevention of STIs. With such a goal GENOMICA and SCIENION have jointly developed a novel multiplex test that combines both companies’ expertise and technologies. SCIENION contributes its proprietary sciFLEXARRAYER non-contact printing technology and consumables, such as sciPLEXPLATES, while GENOMICA applies that technology, combining it with a multiplex PCR, CLART® Technology, allowing the simultaneous detection of bacteria, virus, fungi and parasites on a Low Density Microarray format.
CLART® STIs A&B is a combination of two different detection panels. It provides the end-user with the opportunity to rapidly detect therapy-susceptible or symptomatic pathogens, thus avoiding a potential exponential retransmission into the general population. These CLART® STIs A&B kits, together with the employed microtiter plate format, were validated in cooperation with reference laboratories, university hospitals and family planning clinics. Sensitivity and specificity values of circa 94% and 99% respectively were obtained, with exception of Mycoplasma genitalium, which shows a reduced sensitivity and specificity in swabs samples (86% and 89% respectively). The kit is now a CE-IVD product (CE NB0318).
Dr. Rosario Cospedal, CEO of GENOMICA S.A.U, stated: “We are very happy to launch our new IVD test kit for the detection of STIs based on our partnership with SCIENION. Our strategic cooperation proved once again successful as the technologies of our companies optimally complement one another. This gives us a competitive advantage in the molecular diagnostics market and CLART® STIs A&B has the potential to become a benchmark in clinical STI diagnosis.”
Dr. Holger Eickhoff, CEO of SCIENION AG, added: “According to a recent publication of the WHO, sexually transmitted infections and the high morbidity associated with STIs remain an important focus area for global public health. Joint efforts of different players are necessary to control the expansion of these diseases. We are happy to contribute to this goal with easy-to-use, cost-effective and reliable in vitro diagnostics as developed together with GENOMICA.”
The existing collaboration between SCIENION and GENOMICA aims at accelerating the development of better and safer in vitro diagnostics. The companies jointly seek to offer new services for customers in the microarrays life science industry. These services range from assay development to manufacturing of microarrays individually tailored to the needs and specifications of customers.
Please, visit our joint booth at MEDICA 2014, Nov. 12-15, Düsseldorf, Hall 3 / booth 3A42
GENOMICA S.A.U. develops, produces and commercializes in vitro diagnostic products as well as services for genetic identification. During the last 22 years, the company has been a pioneer in molecular diagnostic tools using the multiplexing PCR technique as the basis of a sensitive, specific and robust assay. GENOMICA holds all the certifications and accreditations necessary to ensure the highest quality standards of its products and services from R&D to the market. The development of its own diagnostic platform CLART® (Clinical Array Technology), combined with a high production capacity and protocols automation, has allowed the company to achieve a very successful internationalization process, being nowadays present in 40 countries around the world.
GENOMICA has developed diagnostic tests for Human Papillomavirus, respiratory viruses, Herpes virus, Enterovirus, microorganisms causing Sepsis and Gastroenteritis. With the launch of the new kit line (CLART® CMA) for the detection of somatic mutations involved in tumor response to therapy, GENOMICA has entered into the field of medical oncology and personalized medicine. For more information visit www.genomica.com.
SCIENION AG and its US subsidiary SCIENION US, Inc. provide systems and services for the contact-free printing of biological and chemical agents for diagnostics, pharmaceutics, veterinary, plant and food analytics and research. Addressing the dynamically increasing needs for miniaturization and multiplex analyses, SCIENION offers a unique technology portfolio that has been continuously expanded over one decade. SCIENION provides flexible solutions for research and development, wherein solutions for production purposes are customized. Systems and software are characterized by their versatility, precision and robustness. The company is a renowned specialist for ultra-low volume liquid handling, particularly for the handling of precious and sensitive compounds of biological or chemical origin. SCIENION’s dispensers allow for contact-free and precise drop spotting in the pico- to micro-liter range and are optimally suited for microarray based analytics – such as for tests with DNA, oligonucleotides, peptides, proteins, antibodies, glycans or for dispensing cells onto various substrates. The company operates from two sites in Germany, Dortmund and Berlin, and has a subsidiary in New Jersey, USA.
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