Profiles of IFCC Corporate Members
Abbott Laboratories
Founded in 1888 by Dr. Wallace Calvin Abbott, a Chicago physician, Abbott Laboratories is a highly diversified health care company that discovers, develops, manufactures and markets products and services that span the continuum of care - from prevention and diagnosis to treatment and cure. Headquartered in north suburban Chicago, Abbott serves customers in more than 130 countries, with a staff of 70,000 employees at more than 135 manufacturing, distribution, research and development, and other locations around the world. Abbott's products fall into four principal business arenas: pharmaceutical, hospital, diagnostic and nutritional products.
Website: www.abbott.com
Agappe Diagnostics Ltd
Manufacturers of complete range Diagnostic Reagents like Biochemistry kits, Serology, Immuno Turbidometry, Coagulation, Hematology Reagents and system packs for Biolis series. Products carry CE Marking. ISO 9001-2008 and 13485 - 2003 certified company. Also deals in a range of Fully Auto and Semi Auto Analyzers for various applications. We are exclusive distributors for world famous brands Like Tokyo Boeki Biolis Series and Mindray.
Web site: www.agappe.com
ANALIS R&D Diag
For more than 25 years, the "ANALIS R&D Diag", group specialized in electrophoresis, has developed kits for in vitro diagnostic, which have been distributed throughout the world. As a result of our long experience in designing kits for electrophoresis using agarose gels, Analis has developed kits for Capillary Electrophoresis. CEofix™ kits for Capillary Electrophoresis presented here are for Clinical Routine as well as Clinical Research:
- Carbohydrate Deficient Transferrin kit is used to detect AUD (alcohol use disorder). The same kit has been used for Congenital Disorder of Glycosylation (CDG) and for transferrin in Cerebrospinal Fluid (CSF). This kit is FDA device listed and has CE-IVD label for Europe.
- Hemoglobin analysis including variant analysis is possible using two buffer systems (alkaline and basic). The hemoglobin kits are CE-IVD labeled for Europe.
- More generic buffers are also available which allow analysis of proteins for example in CSF or for peptides such as glutathione (GSH-GSSG) in blood.
- Anions, organic acids or cations may also be analyzed using specific applications.
- And a special dynamic coating may be used to facilitate CE-MS applications for proteome biomarker.
"R&D Diag" is composed of highly trained people, who offer assistance including running customer samples. We welcome ideas and projects in developing new applications using the high resolution power of Capillary Electrophoresis.
Website: http://www.analis.com/ and http://ceofix.analis.be
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma is the core operating company for all operations of the Asahi Kasei Group which serve the health care industries. The product range includes pharmaceuticals, medical devices, pharmaceutical intermediates, diagnostic reagents, nutritional products, and animal health products.
The Diagnostics Department develops and manufactures enzymes for clinical chemistry use, reagents, diagnostic kits, and human enzyme calibrator for standardization, employing state-of-the-art biotechnology, for marketing to reagent manufacturers, OEM reagent manufacturers, and hospital and commercial laboratories. Our focus is on value-added, continuous innovation and quality improvement of enzymes and enzyme-related products to meet the increasing demands for greater measurement accuracy and product-handling flexibility in the clinical chemistry marketplace.
Website: http://www.asahi-kasei.co.jp/asahi/en/index.html
Axis –Shield POC AS
Axis –Shield POC AS is a public diagnostics company with products and patent protected technologies for chemical analysis of blood samples. Changes in blood protein concentrations are measured as indications of illness, or as the case may be, of improvement or deterioration of clinical conditions.
AXIS is actively taking part in and has to some extent been a pioneer in the development of technologies for new commercial analytical products.
AXIS has developed new products or technologies in the following areas:
- Alcohol abuse - %CDT assay
- Diabetes - Glycohaemoglobin assay
- Cardio-vascular disease - Plasma homocysteine assay.
AXIS operates in defined segments of the diagnostics field, and even though AXIS is becoming increasingly oriented, its focus is still on R&D and production.
Website: http://www.axis-shield.com/
Beckman Coulter: Improving Patient Health and Reducing the Cost of Care
Beckman Coulter is an organization with one of the most comprehensive product portfolios spanning the continuum between life science research and clinical diagnostics. When laboratories choose Beckman Coulter as their partner, they receive distinct advantages in today’s marketplace: a legacy of quality, superior brand equity, and a highly capable team of professionals with a single focus – making laboratories more efficient and productive. We are able to design, develop, manufacture, sell and support testing systems that simplify and automate complex biomedical testing.
Our customers include hospitals, physicians’ offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions.
- Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients.
- Instruments for life science research are used by scientists as they study the causes of disease, identify new therapies, and test new drugs.
In fact, Beckman Coulter has placed more than 200,000 clinical and research instrument systems in laboratories around the world, earning the company $3.1 billion in annual revenue.
Headquartered in Orange County, California, Beckman Coulter employs about 12,400 people worldwide, and operating in more than 50 sites on all continents.
By offering laboratories the tools that increase the accuracy of test results and velocity of decision-making, Beckman Coulter is dedicated to improving patient health and reducing the cost of care.
Website: http://www.beckmancoulter.com/
BD Diagnostics - Preanalytical Systems
BD is a worldwide medical technology company specialising in the field of healthcare for over 100 years. With a mission "to help all people live healthy lives" BD has committed itself to contribute to medical progress by providing safe, accurate and effective systems and solutions for both the patient and the healthcare worker in all fields of the healthcare profession.
BD through its 3 segments BD Medical, BD Bioscience and BD Diagnostics provides the following range of products and services.BD Medical principles products include needles, syringes and intravenous catheters for medication delivery, diabetes care products, prefillable drug delivery devices, surgical blades and regional anesthesia needles, critical care monitoring devices and ophthalmic surgery devices. BD Bioscience principle products include fluorescence activated cell sorters and analyzers, cell imaging systems, monoclonal antibodies and kits, reagent systems for life sciences research, tools to aid in drug discovery and growth of tissue and cells; and diagnostic assays.
BD Medical principles products include needles, syringes and intravenous catheters for medication delivery, diabetes care products, prefillable drug delivery devices, surgical blades and regional anesthesia needles, critical care monitoring devices and ophthalmic surgery devices. BD Bioscience principle products include fluorescence activated cell sorters and analyzers, cell imaging systems, monoclonal antibodies and kits, reagent systems for life sciences research, tools to aid in drug discovery and growth of tissue and cells; and diagnostic assays.
BD Medical principles products include needles, syringes and intravenous catheters for medication delivery, diabetes care products, prefillable drug delivery devices, surgical blades and regional anesthesia needles, critical care monitoring devices and ophthalmic surgery devices. BD Bioscience principle products include fluorescence activated cell sorters and analyzers, cell imaging systems, monoclonal antibodies and kits, reagent systems for life sciences research, tools to aid in drug discovery and growth of tissue and cells; and diagnostic assays.
BD Diagnostics serves hospitals, laboratories and clinics; reference laboratories; blood banks; research organizations; healthcare workers; patients;physicians' office practices; and industrial microbiological laboratories.
BD Diagnostics - Preanalytical Systems through its BD Vacutainer range offers complete systems for evacuated blood collection using a broad range of tubes, needles, needle holders, and safety devices which are optimally designed and tested for controlling preanalytical variability throughout the specimen collection and handling process.
Through its range of Molecular and Proteomic products BD Diagnostics - Preanalytical Systems provides a range of blood collection tubes for the containment and stabilization of blood samples for diagnostic and research purposes.
BD Diagnostics Systems is a leading provider of products for the safe collection and transport of diagnostics (plated media; automated blood culturing), and of instrumentation for quick, accurate analysis for a broad range of microbiology and infectious disease testing (microorganism identification and drug susceptibility). These products provide the diagnostic industry with high quality, efficient arrays for routine microbiology and infectious disease testing.
Website: http://www.bd.com/
bioMérieux
A world leader in the field of in vitro diagnostics for 45 years, bioMérieux provides diagnostic solutions (reagents, instruments and software) that determine the source of disease and contamination to improve patient health and ensure consumer safety.Our products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
Growth-based microbiology, immunoassays and molecular diagnostics
Our fully automated systems are constantly evolving and must integrate an increasing number of parameters. bioMérieux is one of the few companies mastering the complete range of technologies essential for in vitro diagnostics:
- Growth-based microbiology
- Immunoassays
- Molecular diagnostics
Clinical diagnostics for infectious diseases
We concentrate on diagnosing infectious diseases - in particular, sepsis, healthcare-associated infections, tuberculosis, AIDS and hepatitis - as well as on tests delivering high medical value results for cancer screening and monitoring and cardiovascular emergencies. bioMérieux's primary goals are:
- Reducing time to results to help clinicians choose the right treatment for their patient faster
- Delivering Full Microbiology Lab Automation™ to streamline laboratory workflow and boost efficiency with a complete range of automated platforms for blood culture, identification, antibiotic susceptibility testing and microbial straintyping
Website: www.biomerieux.com
Bio-Rad Laboratories
Founded in 1952, Bio-Rad has its headquarter based in Hercules, California. It has remained at the centre of scientific discovery for more than 50 years by providing a broad range of innovative tools and services.
Bio-Rad employs more than 4,000 professionals worldwide within a network of more than 30 wholly owned subsidiaries serving more than 150 countries. Its two primary businesses include Clinical Diagnostics and Life Science research.
Bio-Rad serves more than 70,000 research, industry and clinical laboratories around the globe. It is world renowned within its core industry segments with customers in hospitals, universities, research institutions, microbiological and environmental inspection agencies, pharmacological and biological research and private industry laboratory.
Bio-Rad is the number one specialty diagnostics company. It holds leadership positions in quality control management, diabetes monitoring, blood virus and autoimmune disorders testing.
Website: http://www.bio-rad.com/
CARE SRL
CARE S.r.l. is an Italian Company dealing with the manufacturing and distribution of in vitro diagnostic devices and development and management of Internal and “External Quality Assessment Schemes” (EQAS) and Internal Quality Control (IQC) profiles for Laboratories all over Italy. Originally, CARE was focused on the production and development of Laboratory immunodiagnostics, specializing in infectious diseases as development of reagents for the diagnostics of Hepatitis and HIV . In 1992 has focused its activity on the production of a complete line of ELISA Immunodiagnostics on microplate for Hepatitis B and Torch Group Diseases, starting to sell these products all over Italy and the world. As far as this activity is concerned, in 1993, CARE achieves the registration of the IVD Supermik (HbsAg ELISA kit) at the Italian Department of Health. Subsequently CARE focuses on the organization of External Quality Assessment Schemes (EQAS), which it supplies all over Italy. CARE has always oriented its productive and development activities to GMP and in June 24, 2004 CARE certified its own Quality System, according to UNI EN ISO 9001:2000 and from 2007 UNI EN ISO 13485:2003 having the following subject: “Design and manufacture of in vitro diagnostic reagents, internal quality control (IQC) materials and external quality assessment (EQA) schemes”
Website: http://www.dicocare.org
ControlLab
Since 1977, ControlLab has been developing products and services aiming at quality control of clinical laboratories in Latin America with technical competence and professional ethics recognised by the market. The continuous improvement based on quality and trust helped ControlLab:
Becomes the first Provider of Proficiency testing licensed by ANVISA/REBLAS - National Agency for Sanitary Surveillance - in Brazil since August/2001;
Conquer the seal ISO9001, with the approval BVQI/ Inmetro and BVQI/UKAS, in June/2003;
Credited by RBC/Inmetro as laboratory of volume and microvolume, in December/2002;
Licensed by ANVISA/REBLAS as Laboratory of Analytical Reference for Quality Control in Clinical
Analyses, Physical-chemical and Microbilogical, in November/2003;
Becomes the first Alternative Proficiency Testing Provider within Brazil approved by the College of American Pathologists, whose approval has initially comprised the areas of Glycohemoglobin and Flow Cytometry since 2006.
Our services (listed below) aim at all laboratories which try to do their best for quality and those who search for technical reliability and efficient control tools:
Proficiency testing (external control): bacteriology, blood components, blood gas, cerebrospinal fluid, clinical chemistry, coagulation, endocrinology, flow citometry, glycohemoglobin, hematology, immunology, immunoproteins, lipids, malaria, micology, molecular biology, NAT, newborn screening, parasitology, protein electrophoresis, specific proteins, spectrophotometer, sweat analysis, therapeutical drugs, serology, transfusion medicine, tumor markers and urinalysis.
Proficiency testing (veterinary medicine): bacteriology, clinical chemistry, hematology, parasitology and urinalysis.
Internal controls: the same as external control.
Calibration: centrifuge, dispenser, micropipette, thermometer and laboratory glassware.
Equipment and product evaluation.
Adviser and working-shops.
Benchmarking.
Headquartered in Rio de Janeiro, Brazil, with 190 employees and 25 scientific-technician assessors, we are committed with innovations and continuous updating to promote an excellence environment for the clinical laboratory community.
Website: www.controllab.com.br
Dako A/S
The Dako Group develops, manufactures and markets products and complete systems that assist medical research and diagnostics in the fields of tissue-based cancer diagnostics, specific proteins and flow cytometry.
Within specific proteins, Dako specializes in the quantitative determination of proteins in body fluids, such as plasma/serum, cerebrospinal fluid and urine. Based on many years of dedicated research, Dako has successfully developed optimized test systems for turbidimetry/nephelometry - some based on the more sensitive technique of particle-enhanced turbidimetry. The portfolio of turbidimetry/nephelometry assays covers the areas of kidney, cardiovascular risk and patient profiling. Protein standardization has always been important for Dako and participation in international standardization committees has brought Dako in the front-line of international protein standardization, particularly through the work of Søren Blirup-Jensen, DVM, PhD.
The flow cytometry portfolio counts more than 200 CE-IVD-labeled reagents. Furthermore, the MultiMixTM color panels for immunophenotyping of leukemia and lymphoma provide a guideline for identification of hematological malignancies with a limited number of antibodies.
Website: www.dako.com
DiaSys Diagnostic Systems
DiaSys Diagnostic Systems is a leading specialist in development and manufacturing of diagnostic systems of high quality combined with ease of use and reduced environmental burden.
Focusing on clinical chemistry and immunoturbidimetric tests DiaSys introduced more than 80 optimised reagents for routine and special diagnostics in user-friendly kits for manual or automated use. Additionally, the programme includes a broad range of appropriate calibrators and controls.
The analytical instrumentation portfolio comprises automated clinical chemistry system analyzers, semi-automated analyzers, POCT instruments for diabetes as well as glucose/lactate analyzers. The instrument line is completed by reverse osmosis systems for purified water.
DiaSys is an ISO certified company since 1996 (valid certificates ISO 13485:2003, ISO 9001:2000). To date, customers and partners in more than 100 countries around the world rely on DiaSys quality.
Website: www.diasys-diagnostics.com
Drew Scientific Co. Limited
Drew Scientific designs, manufactures and sells a range of analytical instrumentation for clinical chemistry and haematology laboratories in both human and veterinary medicine. The company operates from three sites in Texas, Connecticut and England. Drew has distributors in 150 countries.
The company's chemistry product range includes analysers for glycated haemoglobin, haemoglobinopathies and blood chemistry. For haematology the company has a range of systems for human, veterinary and research use, offering five part white cell differential counting and as many as 30 different species.
Both ranges of analysers are backed by a comprehensive range of reagents, calibrators and controls. Drew Scientific is a wholly owned subsidiary of Escalon Medical Corporation Inc.
Website: http://www.drew-scientific.com
Gentian
Gentian is a privately held company with products and patent protected technologies for chemical analysis of human and veterinary samples.
Gentian’s tests are based on particle enhanced turbidimetry and nephelometry. Focusing on precise measurements of kidney function, Gentian has become a leading force in introducing the novel renal marker Cystatin C in routine diagnostics in clinical laboratories worldwide. Superior to serum creatinine, MDRD and invasive renal diagnostic methods, Cystatin C is also an early risk marker for cardiovascular disease. However, the potential of this marker is dependent on a strong assay signal. The technology of enhancing assay signal strength is Gentian’s market advantage.
Gentian is situated in Oslo, Norway and Beijing, China. Valid certificates include ISO 13485:2003 and ISO 9001:2000.
Website: www.gentian.no
Genzyme Diagnostics
Established in 1981, Genzyme Diagnostics formed the first division of Genzyme Corporation, a global healthcare and biotechnology leader.
We offer a unique product portfolio for diagnostic manufacturers and healthcare professionals worldwide, comprising of Diagnostic Enzymes, Clinical Chemistry Reagents, and Point of Care Rapid Tests.
Our competency in microbial fermentation, purification, and reagent formulation allows us to supply more than 50 intermediate products to clinical chemistry manufacturers and over 60 formulated reagents to chemistry instrument manufacturers and clinical laboratories worldwide. These portfolios are focused on Diagnostic solutions for Cardiovascular disease, Diabetes, and Renal disease.
Our OSOM® branded Rapid Tests for infectious diseases and women’s health are developed for use in the point-of-care setting, designed to help physicians quickly and accurately diagnose their patients in order to provide the most appropriate treatment.
Genzyme Diagnostics also has active research programs in a variety of different Clinical areas.
Website: www.genzymediagnostics.com
Hitachi High-Technologies Corporation
Hitachi High-Technologies Corporation is a global company that has specialized in development and marketing in the cutting-edge technologies in a broad range of fields from leading-edge materials, life science products, semiconductor production systems to IT solutions and products. Hitachi High-Technologies is a subsidiary of Hitachi, Ltd. Founded in 1947, the Headquarter is located in Tokyo and there are 28 offices in Japan and 59 offices outside of Japan in twenty-four countries. The company has earned a reputation as a "high-tech" integrator. The amount of consolidated net sales is US$ 8 billion in 2005.
In the life science field, Hitachi High-Technologies Corporation offers clinical equipment and systems including automatic chemistry analyzers and clinical laboratory automation systems achieving world-class results as well as DNA sequencers essential to genome analysis, analytical instruments and electron microscopes to assist in a variety of research and development. Hitachi High-Technologies Corporation also delivers advanced technologies and services in a broad range of areas, including the rapidly advancing field of biotechnology, medical facilities requiring improved safety and labor-saving devices, clinical testing, urgently needed environmental measurement, materials research, and more.
Hitachi High-Technologies Corporation's life science business is able to maintain its leadership position with the efforts of its ISO14001-certified Naka Division, a major hub for R&D and manufacture of the advanced clinical and scientific equipment.
Visit the company's Web site at: http://www.hitachi-hitec.com/global/
Hytest Ltd
HyTest Ltd., founded in 1994, offers innovative solutions for assay development and research applications by providing high-quality immunological reagents in such areas as cardiac markers, infectious, neuroscience, biological warfare agents and autoimmune disease reagents. HyTest is a leading provider of several reagents such as antibodies and antigens of the troponin I, troponin complex and Influenza A and B. HyTest offers also extensive customer services and has a certified ISO 9001:2000 quality system.
Website: www.hytest.fi
Innotrac Diagnostics Oy
Innotrac Diagnostics provide state-of-the-art immunoassay systems for cardiac markers and critical care diagnostics. Automated Innotrac Aio!™ immunoanalyzers are truly easy-to-use, making them ideal both for critical care environment and for larger laboratories. Innotrac Aio!™ is the only continuous and random-access immunoassay system giving rapid and fully quantitative results directly from whole blood, plasma or serum.
Proven Innotrac Aio!™ systems exploit both the benefits of non-enhancement time-resolved fluorometry and Innotrac's patented dry chemistry technology to provide fast and simple assays with no reagent preparation. In addition to being highly sensitive, the 2nd generation Innotrac Aio!™ cardiac troponin I assay brings increased diagnostic usefulness to troponin measurement by reducing interference from cardiac autoantibodies (improved immunoassay, patent pending), also known as interfering factor.
Innotrac Diagnostics Oy, founded in 1995, is an experienced provider of immunoassay reagents and contract manufacturing services meeting the high requirements of clinical laboratories, diagnostics and pharmaceutical industry and research institutions. Innotrac's expertise in streptavidin plate coating and antibody biotinylation is used to provide both off-the-shelf products and products tailor-made to the individual needs of research and industrial partners.
Website: http://www.innotrac.fi/
A. Menarini Diagnostics
Born as a division of pharmaceutical A. Menarini Industrie Farmaceutiche Riunite, headquartered in Florence and with over 13.000 employees in 70 countries, A. Menarini Diagnostics is a health care company with more than 30 years of experience in developing and leading the European market of prevention and focused on diagnostics. For the European healthcare community we are a dynamic and reliable partner providing innovative diagnostic solutions thanks to our deep relation with the market, and therefore, knowledge of its needs.
All therapy decisions are based on reliable informed diagnosis as well as quality of life is related to prevention. These are the main reasons for our daily committed work. By focusing on well-defined and selected diagnostic areas, we create value for the society as a whole. Extensive investments in research, strategic alliances, and a constant, close, and intelligent presence into the healthcare community, allow us to be a leading European company and a trustful partner for both patients and professionals. Our aim is to make diagnostics management easier, more effective and result cost efficient.
All over Europe each client can be supported by one of our more than 700 skilled scientific consultants. In fact we are one of the diagnostics company with the most capillary presence in Western Europe covering with our own network 90.3% of the population and serving a market of 300 millions people. We have 13 fully owned subsidiaries, and in the future we will establish our presence also in East and North of Europe. We have a leading position in the Diabetes monitoring and our activities also cover Urinanalysis, Autoimmune diseases, Hematology, Immunology, Immunohistochemistry, Wet and Dry Chemistry systems.
Website: www.menarini.com
Mitsubishi Chemical Europe GmbH
Mitsubishi Chemical Medience is a subsidiary of Mitsubishi Chemical Corporation. For more than 40 years now, it provides biological and medical/clinical labs with fast and highly precise analysis methods from its extensive and continuously expanded test portfolio. The outstanding quality of its appliances, reagents and service are the basis and the future perspective of the Japanese cooperation with its decades-long success story. Already back in 1982, Mitsubishi Chemical Corporation was the first company worldwide to develop the LPIA (latex photometric immunoassay) method to market maturity. Latest innovative product is PATHFAST® a fully automated chemiluminescence immuno anaylser platform for the determination of biomarkers for fast differential diagnosis in central labs and at the point of care. The Mitsubishi Chemical Medience Group is aiming for further development under the management vision of “Good Health Creator, MEDIcal+sciENCE: Creating a Healthy and Safe Society through Medical Science.” Its core business today comprises the development, production and distribution of analysis devices and reagents sets based on the patented LPIA technology on the one hand, and a significant engagement in the „theranostics” sector on the other. In this sector, the company maintains global connections and cooperations with research companies and internationally operating university factories and labs today. Its major focus on research will also guarantee products with the highest possible state of development in the future. Mitsubishi Chemical Europe GmbH is the representative of diagnostic business in EMEA.
Website: www.mitsubishichemical.com
MorphoSys UK Ltd T/A AbD Serotec
AbD Serotec is the research and diagnostic antibody division of MorphoSys, one of the world's leading antibody technology companies.
The AbD Serotec brand was created in early 2006 to market the combined products and services of Antibodies by Design, Biogenesis, Serotec, and Oxford Biotechnology - more than 14,000 antibodies and immunological reagents, custom monoclonal antibodies developed from the MorphoSys HuCAL library, and large and small scale antibody production and conjugation services.
AbD Serotec prides itself on its commitment to providing its customers in research and industry the highest quality products and services, from its ISO certified production facility in Kidlington, near Oxford UK. This new facility is the AbD Serotec headquarters, and supports sales offices in Raleigh, North Carolina and Duesseldorf, Germany. Custom monoclonal development services are performed at MorphoSys headquarters in Martinsried, near Munich in Germany.
Website: http://www.abdserotec.com/oem
Ortho-Clinical Diagnostics, Inc
Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type, and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com
PerkinElmer and Analytical Sciences
PerkinElmer is a global company focused on improving the health and safety of people and their environment. From earlier medical insights and more effective therapies to cleaner water and safer homes, PerkinElmer touches the lives of millions of people around the world every day. At PerkinElmer, we’re taking action to make people healthier. Our Human Health business develops research and diagnostic instrumentation technologies as well as clinical resources and support services, all to fight illness proactively, provide medical insight more accurately and develop therapies more quickly.
From preconception through early childhood PerkinElmer is actively committed to protecting the health and well-being of expectant mothers, babies and families. Through screening and diagnostic systems, clinical lab services and cord blood banking, we’re integral to the health of your family every step of the way.
Website: www.perkinelmer.com
Phadia AB
Phadia develops, manufactures and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. More than 3,000 laboratories in 60 countries use the company's products.
Supplying seven out of ten allergy laboratory tests worldwide, Phadia has remained the world leader in its field for more than 25 years. Our ImmunoCAP symptom profiles provide allergists, paediatricians and primary care physicians with precise, quantitative measurements of specific IgE levels, supporting the prognosis, diagnosis and follow-up of allergic patients.
Website: www.phadia.com
Radiometer Medical ApS
Radiometer Medical is a leading provider of technologically advanced testing solutions for the acute care segment. Radiometer’s products and services simplify and automate all phases of acute care testing, so hospitals can get fast results, reduce the risk of errors and improve cost effectiveness.
Radiometer’s product offering spans from blood gas analyzers over solutions for transcutaneous monitoring to immunoassay analyzers for measuring cardiac, coagulation, infection and pregnancy markers.
Founded in 1935 and headquartered in Copenhagen, Denmark, Radiometer is a pioneer in blood gas analysis and introduced the first commercially available blood gas analyzer in 1954. A long series of new product platforms have been developed since then making Radiometer the ‘gold standard’ in blood gas analysis.
Also today, Radiometer is focused on innovation and the company invests heavily in research and development of new and improved acute care solutions that enable a fast and precise diagnosis and treatment of critically ill patients.
Radiometer has subsidiary companies in 13 countries that are responsible for the worldwide sales and distribution of products and services.
For more information about blood gas analyzers, transcutaneous monitoring solutions or immunoassay analyzers, visit the Radiometer corporate website at www.radiometer.com
For information about the latest trends within acute care testing, visit the Radiometer knowledge site www.acutecaretesting.org.
Randox Laboratories Ltd.
After more than 27 years in the diagnostics healthcare business, Randox is now firmly implanted as a significant investor to improving healthcare technology. Randox develop and manufacture high quality diagnostic kits, mainly for biochemistry laboratories and more recently for virology and endocrinology. Randox also manufacture diagnostic reagents for veterinary laboratories.
Randox's critical products can be found in over 130 countries throughout the world - in fact, wherever there is a need for disease diagnosis. Consequently the role that Randox products play in healthcare decisions is increasing every day. It is evident that clinical diagnostics are taking centre stage in the fight for improved health. It is commonly acknowledged that as much as 70% of the information used by medical personnel to make a diagnosis is information sourced from the laboratory. Through research and design Randox is helping with improved diagnostic systems to present more patient information to the medical professionals, empowering medical staff with a more complete diagnostic patient profile.
This is why Randox has designed the world's first very exciting biochip array system – evidence™ - a diagnostic system that will change the way we think of diagnostic testing. Instead of a patient sample needing to be sub-divided for each test result, evidence™ offers a diagnostic patient profile with each patient sample. The wealth of information facilitated by the incredible capacity sets new standards in clinical analysis. So now, with evidence™, the patient's need becomes the focus and evidence™ from Randox delivers the results as a 'panel' of test results. Evidence™ from Randox is available now for routine and clinical trial laboratories to measure tumour markers, cytokines, drugs of abuse, fertility hormones, cardiac markers, thyroids and drug residues. Now the 1st Ranplex DNA tests are available for continued research in cancer and heart disease with DNA chip technology on the evidence investigator ™.
Website: www.randox.com
Response Biomedical Corporation
Response Biomedical Corporation manufactures and sells rapid lateral flow immunoassay tests to assist in the diagnosis of cardiovascular and infectious diseases at the Point of Care. The tests are run on RAMP readers, either a portable, single port system or a modular system with the capability of performing upp to six (6) simultaneous assays. Fluorescently labeled antibodies are used to detect specific analytes in small sample volumes. RAMP test cartridges and analysis methods are designed to reduce the variability that is inherent to biological samples and lateral flow immunoassays. Current FDA cleared products for the diagnosis of acute myocardial infarction (AMI) are Myoglobin, CK-MB and the cardiac isoform of Troponin I. For congestive heart failure (CHF) diagnosis the company manufactures both a BNP test for Shionogi & Co Ltd for market in Japan, and an NT-proBNP test. RAMP tests for infectious disease diagnosis are available for influenza A/B test and RSV. RAMP tests are currently in use in Canada, US, EU and the rest of the world. In some regions, Infectious Disease tests are private labelled for 3M Health Care as the 3M™ Rapid Detection system and Cardivascular assays are private labelled for Roche Diagnostics as the Roche Cardiac 200 system.
For more details please visit the website: http://www.responsebio.com/
Roche Diagnostics GmbH
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
SCIPAC
SCIPAC provides a wide selection of human proteins, disease plasma and depleted serums and antibodies for the worldwide clinical diagnostics manufacturers.
Diagnostics assays are a major component of modern medical examination and many hospital laboratories across the world use diagnostics kits containing SCIPAC components. With “Raising the Standard” as a key pursuit they have ISO 9001 and 13485 registration and a constant striving for better standards of production and customer service.
This is appreciated by SCIPAC customers and reflected in the company’s expansion and reach. Their products are now used by assay manufacturers in over 30 countries with 60% of sales to the USA. Sales expansion in both bulk sales and increased product range have meant steady growth with sales have doubling in the past three years. The aim of the founders to provide the complete SCIentific PACkage has been fulfilled very successfully.
The link with academia has always been highly valued and has been expanding over the past few years. Sunny-Lab.com is a new business venture which enables the researcher to obtain smaller packages by direct credit card purchase. This e-commerce site also encourages academics to share information and get feedback on their work. An exciting new venture for a visionary, outward looking company.
SCIPAC is situated at Sittingbourne, 40 miles southeast of London.
Website: www.scipac.com
Sebia S.A.
Since its creation in 1967 SEBIA has gained a solid reputation as a company specialized in clinical electrophoresis. Electrophoresis has many applications such as the analysis of proteins present in the serum or in other biological fluids. It is very useful for the diagnosis of pathologies related to cancer, the search of immune system anomaly or for the detection of haemoglobin anomalies.
Through constant evolution of instruments, equipments and reagents, SEBIA provides small and large laboratories with high quality products and high performance procedures.
From the semi-automated HYDRASYS agarose gel electrophoresis system to the completely automated CAPILLARYS 2 capillary electrophoresis system, Sebia keeps on innovating to meet virtually any need in clinical electrophoresis.
Website: www.sebia.com
Sentinel CH SpA
Sentinel CH SpA is an Italian company founded in 1983.
For over twenty years Sentinel has been committed to the development of innovative ICD devices in the bid to make clinical diagnosis ever more reliable.
In 2006 Sentinel moved to new high-tech premises covering a total area of about 10.000m.
The company is ISO 9001:2000, ISO 13485:2003 and ISO 13485:2003 CMDCAS certified.
Sentinel is compliant with the European Directives (98/79/CE), 21C CFR 820 “Code of Federal Regulations” FDA (U.A. Food and Drug Administration), SOE-98-282 (Canadian Medical Devices Regulations) as well as with directives of other countries, including Canada (CMDCAS). The facility, equipments and Quality System are regularly audited by Certification Body, Registrar Body and by customers and inspected by the National Competent Authority and FDA.
Sentinel’s commitment to comply with IVD regulations has facilitated and supported successful partnerships in the industry as well as the distribution of Sentinel’s products in over 70 countries worldwide.
Sentinel has an active presence at the major international congresses, presenting posters written by its specialised scientist. Sentinel is an active partner of IRMM projects for the release of new References Preparations for proteins.
The Technical and Manufacturing departments count for 70% of the company.
More than 100 different assays, under our own brand and also as customized kits, are manufactured in contamination-free clean rooms (ISO 8 and ISO 7 qualified).
The company’s main areas of activity are:
- Clinical Chemistry
- Immunoturbidimetry
- Calibrators, controls
- Fully automated systems for Clinical and Immunochemistry, Fecal Occult Blood (FOB) testing and Coagulation.
- The new Molecular Biology department initiated in 2008 has its own Production clean rooms (ISO 7) as well as R&D laboratory.
Sentinel Diagnostics: “Watching over Life”
Website: www.sentineldiagnostics.com
Sichuan Maker Biotechnology Co., Ltd.
Sichuan Maker Biotechnology Co., Ltd. is one of the largest companies specialized in manufacturing clinical diagnostic products in China.
MAKER was incorporated in Nov. 1994, since its inception, MAKER focuses on the production of quality diagnostic products through dedicated R&D, strict QC, and advanced manufacturing processes. Now, over 100 SFDA licensed diagnostic products are manufactured and marked throughout China.
Over a decade, MAKER always insists in technology innovation for sustainable development, and has been transformed into one of the leading IVD companies in China.
Website: www.china-maker.com
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is the leading clinical diagnostics company in the world. We are committed to providing clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients.
Our comprehensive portfolio of performance-driven systems, unmatched menu offering, and IT solutions, in conjunction with highly responsive service, are designed to streamline workflow, enhance operational efficiency and support improved patient care.
The depth and breadth of our diagnostic solutions-chemistry, immunoassay, automation, hematology, hemostasis, microbiology, diabetes, urinalysis, blood gas and molecular testing-are designed to meet the growing demands of our customers, today and tomorrow.
Through Siemens extensive expertise in medical imaging and leading-edge information technology, we are also uniquely positioned as the world’s first fully integrated diagnostics company to deliver more personalized care to patients around the globe.
To learn more about Siemens Healthcare Diagnostics, please visit our Web site at www.siemens.com/diagnostics.
Sysmex Europe GmbH
SYSMEX EUROPE GMBH, Germany-based daughter company of SYSMEX CORPORATION, Kobe, Japan, is responsible for customer and sales support for Sysmex's in vitro diagnostic systems and reagents as well as manufacture and sales of reagents for Sysmex's in vitro diagnostic systems in the European, African and Middle East markets.
Sysmex, a manufacturer of comprehensive clinical testing, is engaged in clinical laboratory testing of blood, urine and other specimens, covering the areas of haematology, haemostasis, immunochemistry, biochemistry, urinalysis and faecal occult blood testing.
In the field of haematology, Sysmex holds the global market leader position. In addition to providing instruments and reagents for clinical laboratory testing, Sysmex is also developing a broad range of laboratory information systems and application software, thus offering information technology as part of its comprehensive service and support system. Integration of those various technologies is the driving force behind Sysmex's business activities.
Sysmex is also developing these technologies and expertise to expand its areas of business. For example, it is expanding into such fields as point of care (POC) testing - clinical laboratory tests conducted on the spot, such as in the hospital operating room, intensive care unit, or at the clinic - to enable faster diagnoses, centralized test data management for improved testing efficiency, and the establishment of local healthcare networks to link hospitals and clinics.
At the same time, Sysmex is also creating new core technologies to address the challenges of disease prevention and early cancer detection.
By expanding its business into these healthcare testing fields, Sysmex intends to contribute to the creation of a vibrant and healthy society. In addition, Sysmex is applying the technologies that it has devised in the field of clinical laboratory testing to industry, sports, and other new business fields.
At Sysmex, we have adopted two commitments to the future: to continually develop advanced technologies and create value with the aim of serving our customers and society at large; and to play a key role in contributing to the health and vitality of people the world over. It begins with close attention to the voices of our customers.
Website: www.sysmex-europe.com
The Binding Site Group Ltd.
Binding Site is a British-based company specialising in the research, development and production of immunodiagnostic kits and reagents. Binding Site manufactures a wide range of high quality and innovative products used in clinical laboratories world-wide. International support is provided in the UK, USA, Canada, Germany, Austria, France and Spain from Binding Site offices and a network of distributors in over 60 other countries.
The origins of the company go back to the early 1960's when antisera were produced to meet the needs of the Immunology department within the University of Birmingham Medical School. The range of antisera produced was small but novel and of a very high quality, leading to numerous requests for material from Immunology groups around the world. During the ensuing years the range of antibodies grew rapidly and in the early 1980's a commercial immunodiagnostic company, Binding Site, was founded.
Expertise in immunisation and processing techniques has enabled us to build a range of immunodiagnostic products aimed at fulfilling the needs of commercial and government funded laboratories in a range of markets - Hospitals, Reference Centres, Universities, Pharmaceuticals, Therapeutics - whatever their size or complexity.
Innovative new products and improved product performance are the benefits of our collaborations with numerous centres of excellence, coupled with a highly professional scientific and technical manufacturing staff.
Our product portfolio has grown to include the most comprehensive range of assays for Primary Immunodeficiency in the world. We have also been able to develop the Freelite assays, the first nephelometric tests for measuring free immunoglobulin kappa and lambda light chains in serum. These assays give a sensitivity, accessibility and consistency never before achievable, allowing significant improvements in laboratory and clinical practice for the detection and monitoring of B cell malignancies.
Rigorous quality assurance procedures help ensure that we provide only products of the very highest standard and with technical support and educational programmes offered world-wide we are able to offer all of our customers the benefits of our technical expertise and knowledge.
Website: www.bindingsite.co.uk
Thermo Fisher Scientific Oy
Thermo Fisher Scientific Oy's Clinical Chemistry & Automation Systems business develops, manufactures and markets fully automated analyzer systems and modular laboratory automation for clinical laboratories. With over 30 years of experience, Thermo provides user-friendly Konelab analyzers, which are supported by technical and application services. An extensive range of system reagents are offered for clinical chemistry tests, specific proteins, electrolytes as well as TDM and DoA tests. TCAutomation laboratory automation systems serve automated sample pre-handling, like decapping, aliquoting and centrifugation. The workcell configurations ensure efficient sample processing by using a common sample entry and user interface for several analyzers.
Automation can be started with just a single pre-analytical process, and expanded step by step towards total laboratory automation. Thermo Fisher Scientific Oy is part of Thermo Fisher Scientific Corporation. Website: http://www.thermo.com/.
Wako Pure Chemical Industries, Ltd./Wako
Wako Pure Chemical Industries, Ltd. is a leading provider of clinical chemistry reagents and systems. Since 1922, Wako has devoted itself topioneered the research, development, and manufactureing of high quality reagents since 1922. Headquartered in Osaka, Japan, Wako is an, becoming a international global in vitro diagnostic company with research, manufacturing, and sales offices and marketing in Japan, the United States and Germany. Wako is committed to the development of novel diagnostic and research reagents in the life sciences.
Through intensive studies in clinical chemistry, immunoassay and microfluidics, Wako keeps abreast of the latestprovides state-of-the-art diagnostic developments in medical science, systemsin order to develop products tailored to the sophisticated requirements of our clients in various medical fields.
Wako has developed a wide range of liquid chemistry reagents designed for use in the clinical laboratory. They include innovative reagents assays that use microfluidics (AFP-L3% and des-carboxy Prothrombin), liposome technology, the reagent for total complement activity (CH50), and the a micro-organism detection system using LAL and SLP to detect endotoxin, glucan, and peptidoglycan. Wako provides advanced assays for Free Fatty Acid (NEFA), enzymatic Creatinine, hyaluronic acid, as well as superior reagents for standard clinical chemistry analytes.. Wako has a consistent focus on the development of new and important tests for the diagnostic community. For example, Wako now provides a test that includes both novel chemistry and instrumentation for the measurement of AFP-L3%, a test that will improve the chances for finding liver cancers at an earlier and more treatable stage. Recently, Wako has also introduced a bench top clinical analyzer that utilizes many of these chemistries at the point of care in the physician's office, bringing the value of testing closer to the patient.
As one of the industry's leading pioneers, Wako will continues to develop and supply chemicals, reagents, and instruments of the highest quality to meet the growing and changing needs of the diagnostic and research communities.
Website: www.wako-chem.co.jp
Walter De Gruyter, Berlin/New York
Walter dDe Gruyter is an international academic publishing house headquartered in Berlin, Germany - with a US branch based in New York. For decades, de Gruyter has been synonymous with superior scientific literature. Annually, we publish more than 250 700 new titles, both print and ebooks, covering the areas of humanities, medicine, mathematics, natural sciences and law in both German and English. In addition, we offer more than 60 100 academic journals, as well as a variety of electronic media publications. As we cater to the academic world, de Gruyter is particularly committed to the highest standards of quality in serving its customers and authors.
De Gruyter is widely recognized for its acclaimed Pschyrembel® Series. Pschyrembel is the standard German medical reference book - a powerful and competent encyclopaedia, continually updated to reflect cutting-edge developments in medicine.
We further have a strong reputation in scientific textbooks with the well-known Bergmann/Schaefer, Lehrbuch der Experimentalphysik (textbook for experimental physics) in 8 volumes as well as translations from English and French in physics (Jackson, Cohen-Tannoudji). In chemistry, de Gruyter offers a wide range of textbooks ranging from the introductory Riedel, Anorganische Chemie (inorganic chemistry), the standard text for undergraduate chemistry students, to Holleman/Wiberg: Lehrbuch der Anorganische Chemie (textbook for inorganic chemistry), the "bible" for students and chemists alike. Beyond works for students de Gruyter publishes high quality English language handbooks for researchers such as Schinzel: Catalogue of Unbalanced Chromosome Aberrations in Man, the new title Hörnlimann: Prions in Humans and Animals and the series Handbook of Zoology. De Gruyter is currently establishing a book program in labororatory diagnostics. Upcoming titles cover issues such as Molecular Diagnostics of Infectious Diseases, Diagnostic Enzymology as well as Vitamins in the Prevention of Human Diseases.
Last but not least, the de Gruyter journals are well-established in their specific markets. In the biochemical and medical fields, Clinical Chemistry and Laboratory Medicine (CCLM), LaboratoriumsMedizin (Journal of Laboratory Medicine), Biological Chemistry, Biomedizinische Technik (Biomedical Engineering) and the Journal of Perinatal Medicine each offer a high quality, international forum for scientists in the respective disciplines.
Website: www.reference-global.com
Wiener Lab
Wiener lab. develops, manufactures and markets FDA approved diagnostic reagents since 1960. It is also the distributor of technical equipment from international renowned companies. It is located in Rosario, Argentina, in a crossroads of the Mercosur. It is the leading manufacturer of diagnostic reagents in Latin America and its sales network includes six associated companies in Brazil, Chile, Colombia, Mexico, Peru and Venezuela, and has sales representatives in the other countries of the region. Its exports operations for Eastern Europe and the Middle East are performed through its associate company Wiener lab. Switzerland.
Wiener lab. products are focused on clinical analysis and specialised hospital laboratories. Its products are based on the research, development and production of monoclonal antibodies to manufacture several tests: Hepatitis, Pregnancy, Blood Typing; production and purification of antigens for the detection of parasitic (Chagas'disease, Toxoplasmosis), bacterial (Brucella, Salmonella) or viral (Hepatitis, AIDS) diseases; applied research on recombinant nucleic acids and nucleic acid probes, as well as PCR (Polymerase Chain Reaction) procedures; design of recombinant proteins and synthetic peptides with antigenic activity; and research on different branches of Biotechnology. The leading edge technology in the research and development of diagnostics kits for Chagas'disease have earned Wiener lab. an outstanding position within the diagnostic market.
Some of Wiener lab. products are the result of joint projects with renowned research centres. Along with the Program for Appropriate Technologies in Health (PATH-Seattle, USA), Wiener lab. has developed a high sensitivity, non-instrumental procedure for HIV carriers screening, the D.I.A. (Dot Immuno Assay) HIV 1+2, which has been evaluated and approved by the World Health Organisation.
Wiener lab. keeps up to date in scientific research and manufacturing technologies in order to improve and develop products of advanced technology.
Website: www.wiener-lab.com.ar
