AusAm Biotechnologies Receives Approval to Market
AusAm Biotechnologies Inc has received the CE Mark of approval for the Microalbumin Plus™, which aids in the detection of microalbuminaria in at-risk patients, such as diabetics. Microalbuminaria is a condition that may indicate the presence of kidney disease and the need for further testing. The Microalbumin Plus is now cleared for sale in all European Union member countries. AusAm Biotechnologies received US Food and Drug Administration marketing clearance for Microalbumin Plus in August. Microalbumin Plus increases the ability to measure some intact albumin in urine that is not detectable by commonly used urine tests.
In a recent study, Microalbumin Plus detected microalbuminaria 1 to 12 years earlier than widely used commercial tests in diabetic patients who eventually developed overt kidney disease. Without proper treatment, the time between the beginning of diabetic kidney damage and end-stage kidney failure is about 5 to 7 years. However, if detected in the initial stages, the onset of kidney disease can be slowed, halted and, in some cases, reversed with common drug therapies such as angiotensin converting enzyme (ACE) inhibitors and angiotensin-2 receptor blockers (ARBs).
Contact: AusAm Biotechnologies Inc (310) 260-9222
Cardinal Health’s Global Calibration Laboratory Receives NVLAP Accreditation
The Radiation Management Services business of Cardinal Health Inc has achieved NVLAP accreditation by the National Institute of Standards and Technology for its Global Calibration Laboratory. The accreditation is administered by the Institute’s National Voluntary Laboratory Accreditation Program (NVLAP.
“The majority of labs are not as accurate or technically competent as NVLAP accreditation requires, leaving them liable to regulatory problems,” says Clare Grehofsky, director, Global Calibration Laboratory. “With NVLAP accreditation, customers can be assured that they are getting the best possible calibrations with the most accurate results.”
This accreditation means that Cardinal Health’s Global Calibration Laboratory operates in accordance with NVLAP management and technical requirements pertaining to quality systems, personnel, accommodation and environment, test and calibration methods, equipment, measurement, traceability, sampling, handling of test and calibration items, and test and calibration reports.
NVLAP is comprised of a series of laboratory accreditation programs, each of which includes specific calibration and/or test standards and related methods and protocols assembled to satisfy unique needs for accreditation in a field of testing or calibration. NVLAP accredits laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests.
Contact: Cardinal Health Inc (516) 870-0100
LifePoint Receives Patent for Enhancing THC Immunochemical Assays
LifePoint Inc has been granted approval from the United States Patent Office for a patent entitled “Novel Reagents for Detecting Cannabinoids” containing 62 claims. This device and method patent describes the synthesis of novel cannabinol-based tracers suitable for use in immunoassays for the detection of marijuana or its derivatives in biological fluids.
“This invention is of great value to LifePoint because it allows us to develop new detection reagents with greater flexibility in customizing synthesis of key assay components,” says Thomas J. Foley, PhD, LifePoint’s senior vice president of research and development. “The invention allows for the use of structurally similar THC analogs rather than the parent drug molecule to be used in the testing process. The use of this invention not only improves the reagent performance in the flow immunosensor technology, but also decreases the cost at which new tests can be developed for the LifePoint® IMPACT® Test System.
Contact: LifePoint Inc (909) 418-3000
Abbott Laboratories Expands Crohn’s Disease Clinical Trial Program
Abbott Laboratories is expanding its immunology clinical trials program to include an additional Phase III study evaluating the potential of HUMIRA® (adalimumab) in Crohn’s disease, a chronic inflammatory disease of the gastrointestinal tract. In this autoimmune disorder, a human protein, tumor necrosis factor-alpha has been suggested to play a role in the disease development. Data from clinical studies suggest that treatments that inhibit tumor necrosis factor-alpha may be effective in these disease states. HUMIRA, which is a human monoclonal antibody that resembles antibodies normally found in the body, works by specifically blocking tumor necrosis factor-alpha.
“Abbott is committed to exploring the full therapeutic potential of HUMIRA,” says Jim Lefkowith, MD, divisional vice president, Immunosciences Development, Abbott Laboratories. “Based on the recent approval of HUMIRA for rheumatoid arthritis, we’re excited to be expanding programs that will help us understand the effect of HUMIRA on other autoimmune diseases, in addition to our continued programs in rheumatoid arthritis.”
Contact: Abbott Laboratories (800) 633-9110
Beckman Coulter Updates SYNCHRON LX® Closed-Tube Sampling Devices
Beckman Coulter Inc has updated the closed-tube sampling (CTS) capabilities on its SYNCHRON LX20 PRO and SYNCHRON LXi 725 clinical systems to include a wider range of sample tubes. Now, in addition to performing CTS on BD Hemogard tubes, clinical laboratories can use the technology on Greiner VACUETTE blood collection tubes.
CTS technology features a device with the ability to pierce the rubber specimen tube cap, allowing the sample to be aspirated automatically through the cap. As a result, manual de-capping and re-capping of specimen tubes is reduced, helping laboratories improve efficiency and turnaround time.
The CTS devices on both systems can accommodate VACUETTE blood collection tube sizes 13×75 mm and 13×100 mm in serum or plasma, gel or non-gel, with pull or twist caps. The systems will continue to accommodate BD Hemogard blood collection tube sizes 13×75 mm, 13×100 mm, and 16×100 mm.
The SYNCHRON LX20 PRO’s test menu includes more than 100 reagents comprised of general chemistries, critical care chemistries, proteins, serologies, and esoteric chemistries, as well as therapeutic drug monitoring and drugs-of-abuse testing (DAT) reagents.
The SYNCHRON LXi 725 features 137 chemistry and immunoassay tests as well as innovative data management and automated sample handling. The system’s parallel processing technology, which allows both immunoassay and chemistry testing to be performed at the same time for maximum efficiency, enables the SYNCHRON LXi to perform a basic metabolic panel in less than 2 minutes while a critical troponin I test result can be delivered in about 14 minutes.
Contact: Beckman Coulter Inc (800) 352-3433
Online Media Expert Assists Researchers With Cell Culture Formulation Issues
Sigma-Aldrich has launched an exclusive web tool, the Media Expert™ at www.sigma-aldrich.com/me, to assist customers with cell culture media component and formulation issues. In addition, the Media Expert provides customers with the tools to determine why a particular medium formulation is used, what it does, and the benefits or pitfalls associated with it.
Visitors to the Media Expert will find data on:
- – The medium’s primary function in vivo and in vitro with graphic representations and pathways
- – The chemical nature of each component
- – Relevant cellular chemistry related to the component
- – Raw material forms and sources of the component
- – Use recommendations for the component
- – Formulation strategies for the component
- – Relevant references
Each media component discussion is essentially a mini-review article to help customers better understand the component’s role in cell culture. The reviews list Sigma-Aldrich products that are relevant to each discussion and address a myriad of common symptoms seen in cell culture systems, with suggestions of possible causes and solutions for relieving the symptoms observed.
A flash-animated tutorial takes new users step-by-step through the Media Expert’s capabilities and functions.
Contact: Sigma-Aldrich Corporation (800) 521-8956; (314) 771-5765
New Study Details How Infectious Prions Can Be Removed
Infectious prions can now be removed from blood prior to a transfusion, according to a new study conducted by Samuel Coker, PhD, Technical Director, Pall Corporation, and the New York State Institute for Basic Research. Infectious prions are the cause of fatal degenerative diseases, including variant Creutzfeldt-Jakob Disease, the human form of mad cow disease.
The study evaluated a prototype leukocyte (white blood cell) reduction filter containing new proprietary media in removing infectious prions, specifically from scrapie-infected red blood cell concentrates. The filtered blood was injected into a test group and non-filtered blood into a control group of hamsters. The results show that the new filter effectively reduces infectious prions from red blood cell concentrates below the limit of detection of the Western blot assay. None of the hamsters injected with the filtered red cell concentrates developed the disease.
“The use of this revolutionary filter technology may one day protect patients from the transmission of infectious prions,” says Dr. Coker. “Using a filtration approach to reduce prions in blood may be a practical way to increase transfusion safety since leukocyte filtration is already a routine practice in most blood centers and hospitals around the world. The new filter technology combines leukocyte filtration with prion removal in one small device.”
Additional in vitro and in vivo animal studies with the prototype filter are ongoing. Pall’s prion reduction technology also holds promise for its potential to detect prions in blood.
“Currently there is no sensitive blood screening test that can be used on live animals or people. The ability to detect prions in blood will enable early identification of infected animals before they manifest clinical signs or symptoms of disease and prior to their use as a food source,” Dr. Coker says. “Helping ensure the safety of the food supply can have a major impact on protecting the public from this insidious and fatal disease.”
Contact: Pall Corporation (516) 484-5400
Premier Awards 2-Year Contract to Instrumentation Laboratory for Critical Care Portfolio
Instrumentation Laboratory (IL) has been awarded a new 2-year contract with Premier Inc for its entire portfolio of blood-gas products. This new agreement continues a relationship that began in January 1998 and includes an option for a third year. Premier Inc is a health care alliance of not-for-profit hospitals and health systems.
All of IL’s blood-gas instruments, consumables, and service and information products are included in the contract. The flagship product in the portfolio is the GEM® Premier™ 3000 analyzer for blood gas, electrolyte, and metabolite testing. This analyzer is available with Intelligent Quality Management (iQM™), an onboard quality management system. iQM, available exclusively from IL, delivers automatic, continuous, and real-time quality control.
“The adoption of iQM by Premier members around the country, in a variety of centralized and decentralized sites, has been tremendous and underlines the value that our revolutionary technology brings to patient care,” says Brian Durkin, Director of Sales and National Accounts at Instrumentation Laboratory.
Contact: Instrumentation Laboratory (781) 861-0710
|Global Med Technologies® Inc and Gambro BCT Collaborate to Help Blood Centers Optimize Automated Blood Collection
In order to share critical donor, blood collection, and blood center operations information, Global Med Techologies’ SafeTrace® Donor Management System and the Gambro BCT Vista™ Information System have been integrated. Key features of the Vista Information System, which received FDA clearance earlier this year, include integration with the Trima® Automated Blood Collection System, blood loss tracking, automated donor management, and business decision support. Integrating Vista with SafeTrace enables seamless sharing of critical donor information, creating a real-time, high-performance automated blood collection management system for the blood center.
Technical trials for the two-way Vista and SafeTrace interface were conducted at the San Diego Blood Bank, an independent blood center serving approximately 50 hospitals in the Southern California Region.
“The interface between the Vista Information System and SafeTrace automates and integrates blood center processes and information,” says Thomas F. Marcinek, president and COO of Global Med Technologies Inc. “Our SafeTrace customers will benefit from this interface through enhanced donor recruitment, automated procedure records and performance reporting, and improved process monitoring–ultimately improving the quality of the donation process.”
Contact: Global Med Technologies Inc (800) 996-3428
Beckman Coulter Adds Reticulocyte Webinars to E-Learning Curriculum
Beckman Coulter Inc has added a new series of webinars entitled “Reticulocytes, Counting and New Parameters” to its e-learning curriculum. The new series, available at www.beckmancoulter.com/labquality under Personnel, offers a convenient method for laboratories to build and maintain staff competencies. Users can access the program from any computer with Internet access.
The three-part reticulocyte series discusses the use of the immature reticulocyte fraction (IRF), its clinical utility, and the information it provides about erythropoiesis. Data from extensive IRF studies are presented, including the value of IRF in various clinical conditions. The series also explores the functions of reticulocytes, their maturation process, and different reticulocyte counting methods, as well as the process of red cell production.
Each course is approximately 25 minutes and hosted by Dr. Robert Pierre, emeritus professor at both the Mayo Clinic and the University of Southern California. He is also past chairman of the area committee of the National Committee for Clinical Laboratory Standards.
Beckman Coulter’s e-learning courses are accredited by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education program. Participants will receive one unit for each course. Continuing education credits are offered at $20 per unit, while individual course viewing is free.
Other webinars include discussions on cardiac and tumor markers, drug testing, osteoporosis, diabetes management, hemostasis, and cellular analysis.
Contact: Beckman Coulter Inc (714) 961-4810
New Conference Will Focus on AIDS in the Caribbean
The University of Puerto Rico Medical Sciences Campus (UPR), the Caribbean Community (CARICOM), and the Caribbean Epidemiology Centre (CAREC) will produce a conference, “A Multicultural Caribbean United Against HIV/AIDS,” March 5-7, 2004 in Santo Domingo, Dominican Republic. This conference is sponsored by UPR, CARICOM, and CAREC in collaboration with the Office of AIDS Research, National Institutes of Health, US Department of Health and Human Services.
The conference is expected to attract approximately 1,500 delegates, including HIV/AIDS researchers, health care and service providers working with AIDS, and those persons living with or affected by HIV in the Dutch-, French-, and Spanish-speaking Caribbean region.
The primary goal of the conference is to enhance the Caribbean’s regional efforts to work collectively to prevent the spread of HIV; mitigate the impact of HIV/AIDS on health, social, and economic status in the region; improve the regional response to HIV/AIDS through the application of knowledge, research, learning, collaboration, and best practices; and develop a regional research capacity through the promotion of a Caribbean research agenda.
“A Multicultural Caribbean United Against HIV/AIDS” will include scientific presentations on topics such as HIV prevention; vaccines research; treatment, care, and support; stigma and discrimination; prevention of mother-to-child transmission; and issues related to vulnerable populations.
Contact: Joslyn Matthews, Ruder Finn on behalf of the Office of AIDS Research (202) 974-5050
Beckman Coulter and Novation Sign $90 Million Hematology Agreement
Beckman Coulter has renewed its hematology agreement with Novation, the supply chain company of VHA Inc and the University HealthSystem Consortium (UHC). The 3-year agreement, effective November 1, 2003, is valued at more than $90 million and includes Beckman Coulter’s entire line of hematology laboratory instrument systems, consumables, and services.
“This agreement represents an expansion of our relationship with Novation,” says Robert Kleinert, vice president of the Americas for the clinical diagnostics division of Beckman Coulter. “VHA and UHC members will now have access to our new COULTER LH 500 mid-range hematology analyzer and the LH1500 series automation systems, which can manage the entire hematology testing process from pre-analytical sorting to post-analytical storage. In addition, they will continue to benefit from access to our high-volume COULTER LH700 series hematology systems and benchtop analyzers.”
Novation represents the purchasing interests of more than 2,300 health care organizations. VHA, based in Irving, Tex, is a nationwide network of more than 2,200 leading community-owned health care organizations and their physicians. It comprises 25% of the nation’s community hospitals.
University HealthSystem Consortium, based in Oak Brook, Ill, represents 76% of the academic medical centers in the US. This agreement also extends to the 5,400 members and clients of HealthCare Purchasing Partners International (HPPI), another group purchasing organization owned by VHA and UHC.
Contact: Beckman Coulter Inc (800) 352-3433
|COLA and ACE to Offer Laboratory Director Training
COLA and the American College of Endocrinology (ACE) will jointly offer a laboratory director training program in conjunction with the “2004 Endocrine University®” to be held at the Mayo Clinic in Rochester, Minn, on March 20, 2004. Through this arrangement, COLA and ACE will offer more than 20 continuing medical education hours of Category 1 credit. By offering the 20-plus contact hours, this educational program offered by COLA and ACE will meet CLIA requirements for physician-directors of moderate complexity laboratories.
The laboratory director training program will be delivered through a blended approach, in which program participants will obtain approximately 9.5 contact hours through live discussion and lectures and 10.5 hours through online courses offered at www.labuniversity.org. The curriculum for the live courses will include an introduction to laboratory testing, an overview of laboratory director responsibilities, and a course on selecting a laboratory information system for the POL. The web-based courses will include CLIA ’88 Requirements for the POL, OSHA Safety Requirements for the Medical Laboratory, Practical Proficiency Testing, and Basic Quality Assurance Practices for the POL.
Upon successful completion of both live and web-based courses, participants will receive acknowledgment of their accomplishments with a certificate of completion that shows they meet CMS requirements to serve as a physician-director of a moderate complexity laboratory.
COLA is a nonprofit, physician-directed organization that promotes quality and excellence in medicine and patient care through programs of voluntary education, achievement, and accreditation. The mission of ACE is to provide and promote education, research, and communication in the art and science of clinical endocrinology and to provide appropriate recognition of advances and achievements related to clinical endocrinology.
Contact: COLA (800) 981-9883
Dade Behring Wins Award of Excellence
Dade Behring has won the 2003 IPMA International Project Management Award for its work in developing the BN ProSpec® system for in vitro medical diagnosis.
The BN ProSpec system, now installed in nearly 1,000 laboratories globally, is designed to perform specialized plasma protein assays in the medium-throughput laboratory. The IPMA review committee cited the Dade Behring BN ProSpec development team, located in Germany, for its strong focus on customer needs and expectations during the various phases of product development and evaluation. This included work with an advisory board of lab managers from six countries, focus sessions and customer interviews, intensive external evaluations, and continuous improvements both before and after product launch.
Contact: Dade Behring Inc (847) 236-7038