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Celiac.com 05/12/2006 - Dear Colleagues in the Celiac Community: We would like to provide you with a progress report of the Celiac Management Clinic (CMC) at Stanford Medical Center. Realizing that many physicians and gastroenterologists have a limited understanding of the frequency of Celiac Sprue in the population and the subtlety of the clinical manifestations of this disease, we instituted the CMC at Stanford Medical Center in January 2005. This clinic is staffed by Dr. Gail Pyle and myself. A large number of patients who carried the diagnosis of Celiac Sprue have chosen to be seen in consultation--the majority of these did have Celiac Sprue, as estimated from blood antibody tests and the small intestinal (duodenal) biopsy. For many of these patients, comprehensive emphasis on gluten exclusion has been very effective in eliminating symptoms and the malabsorption of nutrients. However, both in this patient group and in those healthy gluten-free Celiac volunteers who participated in the trial supported by the Celiac Sprue Research Foundation in collaboration with the Palo Alto Medical Foundation on pre-treatment of grocery store gluten with a special peptidase(1) there was a surprising discovery. Fully half (~50%) of those presumed to be in remission from the disease had malabsorption of important nutrients. This major finding was a surprise, and it gives us pause concerning Celiac Sprue therapy. Is gluten exclusion not optimal or is it insufficient therapy for this large proportion of Celiac Sprue patients? The concerns about the effectiveness of long-term dietary therapy in Celiac Sprue have prompted us to reassess our approach to this disease. For those of you who reside within reach of Stanford Medical Center, we invite you to visit us at the Celiac Management Clinic for an up-to-date assessment of the status of your Celiac condition. If you are the one out of every two healthy Celiacs with malabsorption, we will take a comprehensive approach to determine the reasons and to facilitate your return to complete remission. If strict gluten exclusion is insufficient to achieve this, we offer other approaches. Indeed, by the end of this year or the beginning of 2007 in collaboration with the Celiac Sprue Research Foundation, we expect to be able to determine the effect of an oral pill therapy for those who continue with malabsorption of nutrients. Stanford accepts most PPO insurance and MediCal and MediCare outpatient coverages. Those who suspect they have Celiac Sprue based on symptoms or blood antibody tests will be seen by Dr. Gray, and those with biopsy-verified disease will be seen by Dr. Pyle. For an appointment, call 650-723-6961, and please state that you wish to see us at the Celiac Management Clinic. Sincerely, Gary M Gray, M.D. Professor of Medicine, Emeritus (Gastroenterology) References: Pyle GG, Paaso, B Anderson, BE, Allen D, Marti T, Chaitan Khosla C, Gray, GM. Low-dose Gluten Challenge in Celiac Sprue: Malabsorptive and Antibody Responses. Clinical Gastroenterology and Hepatology, 3: 679-686, 2005. Pyle GG, Paaso, B Anderson, BE, Allen D, Marti T, Li Q, Matthew Siegel, M, Khosla C, Gray, GM. Effect of Pretreatment of Food Gluten With Prolyl Endopeptidase on Gluten-Induced Malabsorption in Celiac Sprue Clinical Gastroenterology and Hepatology, 3: 687-694, 2005.

Celiac.com - 06/24/2016 - What are the main factors facing children with celiac disease as they transition into teenagers and young adults? There isn't much good data on the transition and transfer of care in adolescents and teens with celiac disease. Recently, a team of 17 physicians from 10 countries, and two representatives from patient organizations examined the literature on transition from childhood to adulthood in celiac disease. Their The Prague consensus report looks to shine some light on the best options for providing optimal transition into adult healthcare for patients with celiac disease. The research team included Jonas F Ludvigsson, Lars Agreus, Carolina Ciacci, Sheila E Crowe, Marilyn G Geller, Peter H R Green, Ivor Hill, A Pali Hungin, Sibylle Koletzko, Tunde Koltai, Knut E A Lundin, M Luisa Mearin, Joseph A Murray, Norelle Reilly, Marjorie M Walker, David S Sanders, Raanan Shamir, Riccardo Troncone, and Steffen Husby. See the numerous author affiliations below. For their study, the team searched Medline (Ovid) and EMBASE for a period covering 1900 and September 2015. To assess evidence in retrieved reports, they used the Grading of Recommendation Assessment, Development and Evaluation method. The current consensus report aims to help healthcare personnel manage celiac disease in the adolescent and young adult, and provide optimal care and transition into adult healthcare for patients with this disease. In adolescence, patients with celiac disease should gradually assume exclusive responsibility for their care, although parental support is still important. Patients should talk with their doctors about dietary adherence and consequences of non-adherence during transition and beyond. In most adolescents and young adults, routine small intestinal biopsy is not needed to reconfirm a childhood diagnosis of celiac disease based on European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) or North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) criteria, However, a biopsy may be considered where pediatric diagnostic criteria have not been fulfilled, such as, in a patient without biopsy at diagnosis, when additional endomysium antibody tests have not been performed to confirm 10-fold positivity of tissue transglutaminase antibodies, or when a no biopsy strategy has been adopted in an asymptomatic child. Source: Gut doi:10.1136/gutjnl-2016-311574 The research team members are variously affiliated with the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden, the Department of Paediatrics, Örebro University Hospital, Örebro, Sweden, the Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham, UK, the Division of Family Medicine, Karolinska Institutet, Sweden, the Department of Medicine and Surgery, University of Salerno, Salerno, Italy, the University of California, San Diego (UCSD), San Diego, California, USA, the Celiac Disease Foundation, Los Angeles, California, USA, the Celiac Disease Center at Columbia University, New York, New York, USA, the Division of Gastroenterology, Nationwide Children's Hospital, Columbus, Ohio, USA, the Primary Care and General Practice, School of Medicine, Pharmacy and Health, Durham University, Stockton on Tees, UK, the Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital, Munich, Germany, with Hungary, representing the Association of European Coeliac Societies, (AOECS), with the Department of Gastroenterology and Centre for Immune Regulation, Oslo University Hospital Rikshospitalet, Oslo, Norway, the Department of Paediatrics, Leiden University Medical Center, Leiden, The Netherlands, the Division of Gastroenterology and Hepatology, Department of Immunology Mayo Clinic, Rochester, Minnesota, USA, Columbia University Medical Center-Division of Paediatric Gastroenterology, New York, New York, USA, Anatomical Pathology, Faculty of Health and Medicine, University of Newcastle, School of Medicine & Public Health, Newcastle, Australia Academic Unit of Gastroenterology, Royal Hallamshire Hospital & University of Sheffield, Sheffield, UK, the Institute of Gastroenterology, Nutrition and Liver Diseases Schneider Children's Medical Center of Israel, Tel-Aviv University, Tel Aviv, Israel, the Department of Medical Translational Sciences & European Laboratory for the Investigation of Food Induced Diseases, University Federico II, Naples, Italy, and the Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense C, Denmark.

Celiac.com 07/07/2020 - Like most people on the planet, people with celiac disease use social media for many reasons, including looking for celiac disease information and support. Can social media be used to improve the management of celiac disease? Saudi researcher Ahmed Al Sarkhy recently set out to investigate social media usage patterns among celiac patients and explore the potential factors that may influence the frequency of its usage. Dr. Al Sarkhy is the Prince Abdullah Bin Khalid Celiac Disease Research Chair at the College of Medicine, and a member of the Gastroenterology Unit in the Pediatric Department, both at King Saud University in Riyadh, Saudi Arabia. Dr. Al Sarkhy conducted an email survey of biopsy-confirmed celiac disease, or their parents, registered in the Saudi celiac patients' support group, and its related social media accounts. A total of 221 people completed the survey. More than nine in ten respondents (96%) said they used social media networks to help manage celiac disease. Only those participants who used social media were included in the final analysis. Nearly 60% of respondents were female. Just under two-thirds of respondents were celiac patients, while just over one-third were parents of celiac patients. According to multivariate logistic regression, celiac patients were twice s likely to use social media than the parents of celiac patients. The most commonly used social media channels include WhatsApp 82.5%, Instagram 62.3%, and Twitter at 58.5% of participants. The results of this survey show that celiac patients commonly use social media to help them manage celiac disease. Dr. Al Sarkhy suggests that it will be beneficial for celiac patients if healthcare providers make themselves available online to provide accurate, reliable information about celiac disease. Do you or a loved one use social media to help manage your celiac disease? How important is social media in helping you get good celiac disease information? Share your experience below. Read more at: Saudi J Gastroenterol. 2020 Mar-Apr; 26(2): 99–104.Published online 2020 Feb 3.

Celiac.com 06/01/2020 - People with inflammatory bowel diseases like Crohn’s disease and ulcerative colitis (UC) can have difficulty determining when their symptoms are worsening, which can make them prone to more complications and hospitalizations, according to Lawrence Kosinski, MD, founder and chief medical officer of SonarMD. That can mean highly variable per patient costs, higher overall costs, and more intense patient management, according to data from DDW. Kosinski and colleagues suggest that profiling chronic gastrointestinal diseases by gauging volatility based on cost might offer a hedge against this volatility, in much the same was as it does on the stock market. “Like stocks in the stock market, diseases can be profiled by their volatility...Variability drives cost for these diseases...Some diseases have high variability (high beta), whereas others have low variability (low beta)...The higher the variability (beta rating), the higher the overall cost/patient,” says Kosinski. To calculate an index and beta rating for chronic gastrointestinal diseases, the researchers used data from nearly 41,000 members of the Health Care Service Corporation, such as professional, facility and pharmacy claims for calendar year 2017. From that data, they were able to calculate an index and beta rating for GERD, peptic ulcer disease (PUD), gastritis, celiac disease, pancreatitis, irritable bowel syndrome, Crohn’s disease, UC, colon polyps and diverticulitis. They began by calculating the total disease specific cost for each condition, and used it to build a GI Disease Index with the total disease specific cost for each GI condition, which they separated into deciles. When they determined the cost per decile for each condition, and compared that with the GI index, they found strongly positive beta scores in celiac disease and UC, but in no other GI conditions. The team notes that less variable conditions have more predicable costs and outcomes, and so may be better suited for bundled payments and more episodic care. According to Kosinski, value-based programs with a focus on care coordination, patient engagement and disease management, can improve care and lower costs, high beta conditions. The team is encouraging insurers and gastroenterologists "to work together to engage patients with high beta conditions, track symptoms, catch deterioration early, and intervene before it becomes a bigger problem,” he said. The result could be healthier patients and better bottom lines for everyone. Stay tuned for more on this and related stories. Read more at Healio.com

Celiac.com 12/01/2017 - Celiac disease is a genetically determined disorder in which affected individuals show an intolerance to ingested gluten (Food Safety Authority of Ireland [FSAI]). It is an inheritable, life-long disease and is characterized by an inflammatory reaction to dietary gluten in the human small intestine. The special feature of the disease is a flattening of intestinal villi along with crypt hypertrophy. As a result, it leads to significant loss of absorptive surface area and resulting malabsorption of nutrients, vitamins and minerals. Untreated celiac disease may be found in the context of symptoms like: anemia, bone diseases, infertility, neurological problems, cancer and other complications due to persistent inflammation and micronutrient deficiencies. Approximately 1% of the United States population has the disease, which is similar to its frequency in the United Kingdom. Only about 10% of affected individuals have been diagnosed thus far [Kagnoff MF (2007) Celiac disease: pathogenesis of a model immunogenetic disease. J Clin Invest 117: 41–49]. At present, the only suitable treatment is strict, life-long exclusion of gluten from the patient's diet. Although a large fraction of patients who attempt to follow such a diet still exhibit signs or symptoms of active disease, there is no available supplementary therapy for such conditions [Ehren J, Morón B, Martin E, Bethune MT, Gray GM, et al. (2009) A Food-Grade Enzyme Preparation with Modest Gluten Detoxification Properties. PLoS ONE 4(7): e6313. doi:10.1371/journal.pone.0006313]. Gluten is defined as a protein fraction from wheat, rye, barley, oats or crossbred varieties and derivatives thereof. Some persons are intolerant to this group of proteins that are insoluble in water and 0,5 M sodium chloride solution [Commission Regulation (EC) No 41/2009 concerning the composition and labeling of foodstuffs suitable for people intolerant to gluten. Official Journal L 16/09 21 January 2009]. To address this problem, the food industry is developing new products for people affected by celiac disease. These new foods are very helpful in diversifying the celiac diet. More available products will increase nutrient consumption, including fiber and minerals, which are often lacking in restrictive diets. Production of gluten free products involves the fulfillment of specific requirements. These products must be free of gluten, which is present in most components of confectionery production. Labeling of the final product is subject to the European Community Commission Regulation No 41/2009 of 20 January 2009, which sets conditions that must be fulfilled by manufacturers. The composition and labeling of foodstuffs suitable for people who are intolerant to gluten is divided into two categories of products according to the nutritional purpose: Gluten free for people intolerant to gluten, and very low gluten content [Wojtasik. A, Daniewski W., Kunachowicz H., 2010. Ocena wybranych produktów spożywczych w aspekcie możliwoÅ›ci ich stosowania w diecie bezglutenowej. Bromat. Chem. Toksykol., XLIII, 2010, 3, str. 362-371]. Selected paragraphs of these labeling rules are quoted below: Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer. The labeling, advertising and presentation of the products referred to in paragraph 1 shall bear the term ‘very low gluten'. They may bear the term ‘gluten-free' if the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer. Oats contained in foodstuffs for people intolerant to gluten must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats must not exceed 20 mg/kg. Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients which substitute wheat, rye, barley, oats or their crossbred varieties shall not contain a level of gluten exceeding 20 mg/kg in the food as sold to the final consumer. The labeling, presentation and advertising of those products shall bear the term ‘gluten-free'. Where foodstuffs for people intolerant to gluten contain both ingredients which substitute wheat, rye, barley, oats or their crossbred varieties and ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, paragraphs 1, 2, and 3 shall apply and paragraph 4 shall not apply. The terms ‘very low gluten' or ‘gluten-free' referred to in paragraphs 2 and 4 shall appear in proximity to the name under which the food is sold. To achieve gluten content as described above, special conditions in work environment must be instituted. Preparation of high quality products that are safe for people affected by celiac disease, the production process must be controlled not only at the production plant. Origin, breeding, harvesting, storage and transport of ingredients must be also taken into account. The best way to ensure the customer about the safety of a given product is to implement a specially designed quality management plan from the very first step of production. In order for products to be gluten-free or reduced in gluten when they reach the consumer, the gluten-free quality of the product must prevail at every stage of production. Cross contamination is the process by which a reduced-gluten or gluten-free product loses that status. It has come into contact with something that is not gluten-free. Cross contamination may happen during primary production, harvesting and storage of grain, during the manufacture of gluten-free or reduced gluten food in the same plant where gluten-containing food is produced. Cross contamination may also occur as a result of poor re-work, incorrect formulation, product carry-over due to use of common equipment, clean-up or sanitation, poor equipment design, human error or the presence of gluten products near exposed product lines. Potential risks, preventative measures and critical control points need to be identified in the handling of ‘gluten-free' or ‘very low gluten' products. (Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A Comprehensive Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441) Raw Materials Origin To minimize risk, producers of raw ingredients have to implement appropriate control practices during crop production, harvesting and storage. Plants should originate from certified seeds which guarantees a high level of species purity. Cleaning of sowing machines is also important because seeds from the previous planting can contaminate new crops. The same rule applies to equipment used for harvesting and transportation. Storage areas should be thoroughly cleaned before filling with new crops. Every magazine should be identifiable and people responsible for crop delivery must be informed and instructed to maintain a gluten free workplace. Producers should produce representative samples for laboratory analysis to verify their product's "gluten free" status. Even on the first level of food production, which is plant growing, training and supervision of employees and producers is critical for maintaining the non gluten status of raw materials. Good training of all staff working at these first stages will help to avoid potential sources of food allergens. This type of training should increase awareness about food allergens and the consequences of unintentional consumption by allergic persons. Workers should be encouraged to report any suspected breaches of protocol to their supervisors and suggest possible improvements [Australian Food and Grocery Council, Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition]. Transport Suppliers of raw materials are obligated to have good allergen management practices to minimize the risk of cross contact between raw materials. Suppliers should provide information identifying any products that contain allergens, the origins of allergenic materials, or those that are likely to cross contamination with allergens. Vendor audits are recommended to verify and explore potential contact with allergenic substances [Australian Food and Grocery Council, Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition]. Storage Manufacturing plants should be designed to accommodate all aspects of the quality control and allergen management plan,. Storage of raw materials should prevent mixing allergens with non allergenic ingredients. To meet this condition, allergenic materials should be kept at separate facilities, or when this is impossible, all raw materials should be covered to avoid allergenic dust contamination. Clear and visible labeling of containers and all equipment should also be implemented. Tools and equipment used for different materials must also be kept separate [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4]. Production To minimize the risk of unintentional contamination of products good manufacturing practices – the Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Points (HACCP) plan must note all specific conditions. The production plan should be designed to avoid production of allergenic and non allergenic foods during the same shift. If this is impossible, non allergenic products should be produced first to avoid contamination from dust. Ingredients containing gluten should be identified by color-coded containers or stickers. Ingredients containing gluten must be added at the end of the shift after gluten free products are completed and removed. Rework containing gluten should be reused into the same products. Appropriate employee training and labeling for rework can also help to minimize the risk of cross contamination through human error. The possibility of contamination can easily be minimized by using dedicated equipment for the gluten free products. When it is impossible to have a separate building, the use of special barriers is necessary. The use of separate space and separate containers for all materials (as above) is recommended for gluten free production. In such conditions ventilation and dust flow must be well controlled. Dust flow in the plant has a potential to carry over allergens from separate spaces of facilities. [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4]. Packing and labeling are also important elements in preventing cross contamination. Packing equipment may also be a source of contamination. The packaging machines and material should be checked for any allergens, e.g. foil coated with releasing agents derived from wheat flour. Appropriate labeling should be use to inform customers who are affected by coeliac disease. Correct labeling should reflect actual and real composition of the product. Labels must also fulfill legislative requirements. To facilitate recognition of gluten free products, labeling must be clear and readable. EU legislation regarding food labeling imposes an obligation to provide true and clear information about ingredients. Alerts to all allergenic ingredients, starch source (plant from witch starch originates) and gluten content are required. The manufacturer is obligated to ensure readability of the above information. Directive 2003/13/EC of 10 February 2003 posted in the Official Journal of the European Union requires that food manufacturers should place notification on labels of any of the fourteen groups of potential allergens responsible for more than 90% of allergic reactions if they have been used as food ingredients (including alcoholic drinks), regardless of the allergen content. The list of allergenic ingredients is constantly being updated. Also, the components derived from allergenic substances must be listed as potential allergens [ Czarniecka-Skubina E., Janicki A. 2009. Znakowani produktów żywnoÅ›ciowych. Informacje żywieniowe i zdrowotne. PrzemysÅ‚ Spożywczy, StyczeÅ„, 34-36; Commission Directive 2003/13/EC of 10 February 2003 amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children. Official Journal of the European Union L 41/33, 14.2.2003] Codex Alimentarius has proposed the introduction of the following descriptions in the vicinity of the product name. If the product comes from natural raw materials that do not contain gluten, it is described as "gluten free by nature," or "product may be used in gluten-free diet" [Hoffmann M., JÄ™drzejczyk H. 2007. Å»ywność bezglutenowa – legislacja i aspekty technologiczne jej produkcji. PostÄ™py Techniki Przetwórstwa Spożywczego, 1, 67-69]. Products low in gluten, are marked with the inscription: "very low gluten foods", "low gluten foods", or gluten-reduced foods [Wojtasik. A, Kunachowicz H., Daniewski W. 2008. Aktualne wymagania dla produktów bezglutenowych w Å›wietle ustaleÅ„ kodeksu żywnoÅ›ciowego. Bromat. Chem. Toksykol., XLI, 2008, 3, str. 229-233; Darewicz M., Jaszczak L.; „Oznakowanie produktów stosowanych w diecie osób chorych na celiakiÄ™", PrzeglÄ…d Piekarski i Cukierniczy, march, 2012.]. Training Employee awareness at all levels of production, beginning with plant growing to finished preparation of proper labels is necessary throughout the gluten free production chain. Everybody must be informed about the consequences of gluten consumption by coeliac patients. Staff who are employed from time to time must be also well trained. Implementation of control procedures and proper documentation will be very helpful in maintaining control. Documentation of the training of every new employee needs to be prepared and maintained. All working stuff and implemented methods must be supervised all the time [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4]. By taking into account all aspects mentioned above and striving to make continuous improvements, manufactures are able to produce safe, high quality gluten free products. The human factor is one of the most important elements in this process because only human mistakes can lead to contamination and only good training and awareness at every stage of production stage can produce the best possible product. Implementation of quality management systems like HACCP or GMP assures customers of food quality and safety, while also allowing the producer to lower production costs related to potential human mistakes. However, nothing will really change the fact that all of the factors described above must be implemented in everyday production, ensuring that they are not simply ideas on the piece of paper. Implementation is the key.

Celiac.com 09/11/2017 - The FDA has granted clearance for Immco Diagnostics' ELISA for celiac disease, and for Roche's Benchtop Analyzer. What does that mean? Immco's test is conducted as a solid phase immunoassay and is intended for the qualitative or semiquantitative detection of IgA or IgG antigliadin antibodies in human blood, and thus to aid in diagnosing patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings. In other important diagnostic news, a benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical was among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency. The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument platform, as well as the Cobas HbA1c test. The fully automated and self-contained Cobas b 101 uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA. The Cobas HbA1c is an in vitro diagnostic test for detecting the presence of glycate hemoglobin, which develops when hemoglobin joins with glucose in the blood, becoming 'glycated'. By measuring glycated hemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. The HbA1c assay is designed for use with the Cobas b 101 platform, which is not a portable home test, but is intended for a clinical laboratory or point-of-care setting. Other instruments receiving FDA clearance in July include a new flow cytometer from Becton Dickinson; an expanded version of Bruker's MALDI Biotyper; and expanded indications for BioMérieux's Vitek MS MALDI-TOF Mass Spectrometery System. The FDA recently cleared the Maglumi 2000 automated immunoassay analyzer from Shenzhen New Industries Biomedical, which uses chemiluminescent technology for running IVD tests on clinical serum samples. The firm's Maglumi 2000 TSH assay for the quantitative determination of thyroid-stimulating hormone in human serum also received 510(k) clearance. The assay is for diagnosing thyroid disorders. These are just a few of many new tests and analysis devices that are changing the way doctors diagnose and manage celiac disease, diabetes, and other diseases. Look for tests like this to have a profound influence on the way diseases are diagnosed and managed in the future. Read more: 360dx.com