Roche and Premier Continue Partnership
Roche Diagnostics Corp and Premier Purchasing Partners LLP have signed a 3-year agreement in which Roche will continue to provide instruments, reagents, and consumables to Premier members. The contract includes MODULAR® ANALYTICS and Integrated MODULAR ANALYTICS systems, as well as the COBAS Integra® Systems, MODULAR PRE-ANALYTICS systems, and VS II Automation Systems. Also included in the contract are MODULAR, COBAS Integra, and Elecsys® reagent kits, automated and visual urinalysis products, and point-of-care coagulation products. The test menu covered by these products includes proBNP, troponin T, free prostate-specific antigen (free-PSA), and D-Dimer, which are measured in patients with heart disease, prostate cancer, and deep vein thrombosis.
The new contracts are a continuation of the long-term relationship between Roche Diagnostics and Premier, which now includes clinical chemistry and immunochemistry instruments and reagents, blood glucose monitoring, and molecular testing.
Contact: Roche Diagnostics (317) 521-2000
President Bush’s 2005 Budget Proposal Calls for Cuts From 2004
President Bush’s budget proposal for the 2005 fiscal year calls for nearly $2.4 trillion in federal spending, but almost half of all federal agencies would experience funding cuts. Specifically, the Health Resources and Services Administration, which administers several programs that provide funding for laboratory and other allied health personnel, would face a $610 million cut from the 2004 appropriation.
Additionally, President Bush proposed substantial cuts in Title VII Allied Health Professions programs, cutting Title VII funding by $283 million, a 93% cut from last year. Funding for the Scholarship for Disadvantaged Students Program, which received $47.8 million in 2004, will receive only $10 million in 2005 under the president’s plan.
Concerned about this year’s budget reductions for important health programs, ASCP (American Society of Clinical Pathology) has joined with more than 300 health care organizations, which include medical specialty and public health related groups, in “Campaign to Increase Function 550.” Function 550 is the budget account that finances the Public Health Service. The campaign is focused on educating lawmakers about the range of threats, including infectious diseases and bioterrorism, and the funds needed by the health care industry to perform preventative research. Campaign participants say that substantial budget cuts in the areas of health care and scientific research put the nation at risk, and they are urging Congress and the administration to allocate additional funding for health care programs.
While health care organizations such as the Allied Health Professions programs and the Centers for Disease Control and Prevention are being “zeroed out” in budget parlance, funding increases are designated for anti-terrorism and military programs. The administration’s 2005 budget would increase federal spending by $31 billion, $29 million of which will go to defense security programs.
The President’s new bio-surveillance initiative for bioterrorism and naturally occurring infections, Bio-Sense, is slated to receive $100 million in funding for 2005. The program employs an advanced approach to infectious disease surveillance, using automated analysis techniques of electronically available health data to highlight potential public heath problems. Another $20 million will be allocated to improve laboratory reporting capacity and advance integration between public health and commercial laboratories.
The National Institutes for Health is expected to receive a slight increase in funding, from $28 billion to $28.8 billion.
Contact: American Society for Clinical Pathology (312) 738-1336
Greiner Bio-One’s Plastic Blood Collection Tubes Can Now Be Used on Beckman Coulter’s Systems
In an effort to facilitate the transition from glass to plastic tubes, Greiner Bio-One Preanalytics announced that its VACUETTE® 13 x 75 mm and 13 x 100 mm plastic blood collection tubes can now be used on Beckman Coulter’s SYNCHRON LX® 20 PRO and LX®i 725 clinical systems. The conventional use of the SYNCHRON system requires the use of glass collection tubes; however, Beckman Coulter now offers a hardware module and corresponding software that enables the system to run with plastic tubes.
The SYNCHRON system performs random access and batch profiling of a broad range of analytes including stat chemistries, general chemistries, infectious disease, TDMs, DATs, thyroids, specialty, cardiac, proteins/serologies, and lipids.
The VACUETTE plastic blood collection tubes used with the SYNCHRON clinical systems are serum, serum gel, lithium heparin, and lithium heparin gel. A small half-moon shape located on the exterior rim of the cap indicates that the specific lot is usable on the systems.
To successfully run Greiner’s VACUETTE closed tubes on the SYNCHRON LX 20 PRO system, new operation software and two hardware modifications are needed. Greiner Bio-One Preanalytics and Beckman Coulter provide support to customers during the integration of VACUETTE tubes on SYNCHRON instruments.
Contact: Greiner Bio-One (888) 286-3883; or Beckman Coulter (800) 854-3633
|Oliver Products Selected to Manufacture Innovative Cardiac Diagnostic Device
Inovise Medical Inc, which recently received FDA clearance to market a device that provides rapid assessment of heart problems, has selected Oliver Products to manufacture and distribute the AUDICOR sensor within the new product.
The AUDICOR system is a cardiac diagnostic tool that provides timely detection of acute myocardial infarction and other serious cardiac conditions. The system uses COR (correlated audioelectric cardiography) to combine an analysis of electrical signals from the ECG (electrocardiograms) with heart sound detection in a correlated report format, without altering current ECG testing procedures. The AUDICOR system works with existing ECG diagnostic procedures to provide timely, accurate, and sensitive cardiac diagnostic information to hospital emergency and other cardiac care areas.
According to sources at Oliver Products, the company has assisted in the design of the new device from Inovise and will assemble, package, and distribute the AUDICOR sensor for use in the new product.
“This is one of the most innovative projects we have ever had the privilege to be involved with, and our employees are very proud to have a role in life-saving technology such as this,” says Jeff Murak, director of sales and marketing for Oliver Products.
Contact: Oliver Products Co (800) 253-3893
FDI Relocates to Larger Facility
Fujirebio Diagnostics Inc (FDI) has relocated its manufacturing operations to an expanded facility in Malvern, Pa. The move enables FDI to combine its development, manufacturing, administrative, and research functions under one roof to support the company’s next phase of growth.
“The move is helping us to more effectively manage our manufacturing operations, as well as the development of new products currently in the pipeline,” says Paul Touhey, FDI president and chief operating officer.
The relocation continues a process of integration at FDI that has been ongoing since the Tokyo-based Fujirebio purchased the company from Centocor in 1998.
Contact: Fujirebio Diagnostics Inc (610) 240-3800
ASQ Releases 2004 Body of Knowledge
In response to the need for a workforce proficient in the principles and practices of quality control, the American Society for Quality (ASQ) has released a new body of knowledge for the certified quality auditor (CQA) examination.
“We’ve gotten a large amount of feedback from the industry about the need to develop a more practical exam, one that actually demonstrates the proficiency of the auditors,” says Sally Harthun, manager, certification offerings, American Society for Quality.
According to Harthun, the CQA examination is a generic auditing exam that tests the principles of auditing in all areas of business. The examination is not a licensed procedure, however, the organization has been recognized as the source of quality standards since 1968.
“Third-party individuals who perform the audits for ISO-registered companies usually receive their credentials through the CQA examination,” says Harthun. “We also offer a biomedical body of knowledge in which professionals in the industry can gain CQA recognition for techniques and procedures.”
The 2004 body of knowledge recognizes the content of the existing body developed in early 2003. The body provides the structure for a systematic, fact-finding process that identifies important job dimensions and tasks, and is performed by certified quality auditors. The complete body is updated every 5 years to assure relevance to the current market.
The CQA examination is a 5-hour test that includes case studies outlining critical details about audit situations. Approximately 15% to 20% of the test is devoted to these types of case studies. Use of scenario details and sample documents included with each case study will allow candidates to apply critical-thinking skills in evaluating realistic situations.
Those who pass the CQA examination receive formal recognition by the ASQ for demonstrating proficiency with the current body of knowledge.
Contact: The American Society for Quality (800) 248-1946
IDS Signs Agreement with Beckman Coulter
Beckman Coulter has granted Immunodiagnostic Systems Ltd (IDS) exclusive rights to manufacture, market, and sell its Ostase®, Microplate (MP) bone-specific alkaline phosphatase (BAP) microplate. IDS acquired the bone formation marker to increase variation in its line of skeletal immunoassay kits for the research and clinical markets.
The agreement between the two companies enables Beckman Coulter to focus on its diagnostics capabilities, while continuing to allow researchers and nonautomated clinical laboratories to benefit from its BAP technology.
“This agreement ensures that clinical research laboratories and smaller clinical laboratories will have access to our Ostase MP assay and the technology that helps measure levels of BAP,” says Mike Whelan, vice president of Beckman Coulter’s immunoassays and nucleic acid testing business center. “Availability of both the manual Ostase assay and the Access Ostase assay for diagnostic use will help to improve management for bone and skeletal disorders like osteoporosis.”
Contact: Beckman Coulter Inc (714) 773-7655
Collaboration Established to Transmit Notifiable Disease Data Between Medical Facilities
In an attempt to accelerate and improve the quality and delivery of disease reports to public health departments, TheraDoc Inc®, the Nebraska Health and Human Services System (NHHS), and Great Plains Regional Medical Center (GPRMC) have joined forces to utilize the real-time surveillance capabilities of TheraDoc’s expert system technology. Through this collaboration, GPRMC is helping the NHHS document occurrences of notifiable diseases by electronically transmitting pertinent laboratory data to the Department of Health and Human Services via TheraDoc’s Public Health Network Assistant (PHNA) solution.
To enable early intervention and documentation of infections and other notifiable diseases, TheraDoc’s PHNA translates raw lab data and presents it to clinicians and public health officials in standardized medical nomenclature. The infrastructure utilizes a standard HL7 message format to enable real-time transmission of notifiable disease occurrences. Critical patient data is automatically delivered to infectious disease professionals as context-specific, actionable information. Additionally, this process monitors several targeted hospital-acquired pathogens to aid clinicians in initiating early treatment and preventing the spread of drug-resistant pathogens. As a result, the PHNA can significantly contribute to the management and reduction of hospital-acquired infections.
“TheraDoc’s standards-based expert system infrastructure fosters the rapid deployment of a real-time system where notifiable disease alerts can now be sent from GPRMC directly to the Nebraska State Health Department,” says Jonathan Olson, TheraDoc’s chief technology officer. “The automated notification process is a breakthrough for public health surveillance, and happens as a by-product of the natural workflow of GPRMC’s clinical professionals.”
In January 2003, GPRMC contracted TheraDoc to implement its clinical decision-support system to enhance the hospital’s infection control, quality of care, and patient safety initiatives. Linked with GPRMC’s multiple information systems, TheraDoc’s knowledge-based technology continually surveys patient population data to detect instances of naturally occurring infectious diseases, chemical exposures, and the targeted introduction of biological agents.
Nebraska’s quest to monitor infectious diseases proved successful within the first 3 months of implementation at GPRMC. TheraDoc’s real-time public health surveillance capabilities came to the attention of Nebraska state epidemiologist, Tom Safranek, MD, who was investigating how the NHHS could receive electronically transmitted notifiable disease reports from individual hospitals across the state. Since that time, TheraDoc has worked closely with Safranek and his team to enable the automated, electronic transmission of GPRMC’s laboratory data to the Nebraska Health and Human Services system.
Nebraska is a leading state in deploying the national electronic disease surveillance system (NEDSS), and in implementing an electronic lab reporting (ELR) system that is capable of receiving data from local and national laboratories. These systems demand strict compliance with national public health data and information system standards as stipulated in NEDSS.
With the instantaneous transfer of data, patient and facility security played a pivotal role in the system’s development. TheraDoc went to great lengths to ensure that the PHNA complies with regulatory standards, including those outlined by the Centers for Disease Control and Prevention. Its integrated surveillance technology and real-time messaging infrastructure provides a solution that enables laboratories to comply with the stringent standards while providing an advanced analysis and notification system to health care organizations across the country. Today, the PHNA’s automatic transmission of laboratory information for notifiable diseases from GPRMC to the NHHS is testament to the overall success of the collaborative effort.
“There is immense value in the timely identification of public health events. Receiving lab data electronically and in real time allows state health departments to respond more quickly to infectious disease outbreaks,” says Olson. “We believe that TheraDoc’s system could serve as a national model of an automated surveillance, messaging, and ELR system that expedites the transmission of critical data from health care institutions to public health agencies.”
Contact: TheraDoc (801) 415-4400
AT&T to Provide Bio-Reference Labs with Data Solution
A 3-year, $1.2 million contract has been awarded to AT&T to provide Bio-Reference Laboratories with an integrated voice and data solution for its headquarters, district branches, and more than 60 patient centers located in the Northeastern United States.
Bio-Reference plans to utilize AT&T’s local and long-distance services and digital subscriber line (DSL) to gain efficiencies in a number of areas, including the ability to electronically deliver patient test results to printers or computers located at several thousand customer sites throughout the Eastern seaboard. The AT&T solution also is expected to provide Bio-Reference with diverse and redundant access for information using its fixed wireless broadband.
“In our business, we need to reach thousands of customers routinely with private medical information, so security is of the highest concern,” says Richard Faherty, chief information officer, Bio-Reference Laboratories. “AT&T provides us with the reliability and security that we need to be competitive.”
AT&T plans to integrate Bio-Reference’s services through its AT&T Business Network (ABN) offer. ABN makes it possible to consolidate communication needs into a single contract, with a single bill and discounts across all services. In addition, through the secure AT&T BusinessDirect® portal, Bio-Reference will gain online access to tools that provide near real-time reports on network performance and direct access to AT&T’s ordering, status, inventory, and troubleshooting management systems.
Contact: Bio-Reference Laboratories Inc (800) 229-5227
FDA Makes Final Ruling on Bar Code Labeling
The Food and Drug Administration (FDA) has released its final rule on bar code label requirements for human drug and biological products. The ruling calls for the inclusion of linear bar codes on most prescription drugs and advocates the use of health industry bar code (HIBC) labeling standards to aid in the reduction of medical errors.
The FDA ruling incorporates previous that required exclusive use of retail-based standards. The changes are based on a review of numerous comments from the industry that raised concerns regarding the exclusion of HIBC standards.
The standards were developed when it became apparent that the existing retail-based bar code standards were inadequate for the specific applications and needs of a health care environment. The all-numeric retail standards, developed for the point of sale needs of retailers have been dissipating within the health care industry since users realized the system did not adequately address patient and consumer safety concerns.
Today’s HIBC standards employ an alphanumeric data structure considered by many industries to be an inherently safer method of encoding data. The FDA’s bar code rule is anticipated to prevent nearly 500,000 adverse events when fully implemented. For more information regarding the HIBC standards, visit www.hibcc.org.
Contact: Health Industry Business Communications Council (602) 381-1091
|Blueair Receives FDA Listing
Blueair Inc was recently listed by the FDA as a medical device establishment. The listing includes the company’s line of Swedish-designed, in-room air purifiers. The units are well suited for those suffering from allergies, asthma, and other respiratory conditions. Originally marketed to DMEs, HMEs, pharmacies, home health care stores, and professional markets, such as allergists, immunologists, respiratory therapists, pulmonologists, and hospitals, the FDA labeling has enabled the air purifiers to reach broader markets, such as clinical laboratories.
“Indoor air quality is two times worse than the air we breath outdoors, and many people are unaware of this,” says Dick Stark, communications manager for Blueair. “In an environment where sterilization is essential, such as in a laboratory, the purification of air in rooms that typically have little ventilation is ideal.”
According to Stark, Blueair units have the two highest clean air delivery ratings in the industry and use HEPASilent™ filtration technology. As a manufacturer of medical devices, Blueair operates under FDA guidelines for good manufacturing practices (GMP) and is subject to occasional inspection by the FDA. The GMP regulations include requirements related to the methods used in and the facilities and controls for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices.
Contact: Blueair Inc (888) 258-3247
Executive War College 2004 Addresses Molecular Diagnostics
The ninth annual Executive War College on Lab and Pathology Management, held April 27–28 in New Orleans, provided evidence that the twin trends of molecular diagnostics and Lean management methods are taking root in the clinical laboratory.
Gene Pawlick, MD, director of Kaiser Permanente’s regional laboratory in Berkeley, Calif, was one of more than 40 speakers. Pawlick shared his experiences with introducing a molecular test into general clinical use within a facility that admits thousands of patients daily.
Most laboratories with active molecular testing programs are national specialty testing laboratories or academic/tertiary center laboratories; only a handful of community hospital laboratories have established molecular testing programs.
Cost is a key issue. Laboratories that do offer molecular tests to clinicians report that reimbursement is barely adequate to cover the cost of tests based on molecular technology. In most cases, laboratories offering these molecular tests are subsidizing the cost of testing through other sources, including grants, clinical studies, and direct-to-consumer offerings, such as paternity testing.
When addressing this topic, most speakers predicted that molecular diagnostics will not take off until reimbursement for new molecular tests reach levels that adequately cover a laboratory’s cost of offering such testing. Even in cases where payors agree to cover certain molecular assays, the reimbursement approved for those tests is sometimes too meager to sustain a lab’s molecular testing program.
This year’s Executive War College also looked at several case studies highlighting the experiences of US laboratories using Lean methods to radically revamp their high-volume facilities. Unlike earlier quality management systems like TQM (total quality management) and CQI (continuous quality improvement), Lean and Six-Sigma can create substantial improvement in a short amount of time, according to several speakers
Fairview Health Services of Minneapolis and West Tennessee Health System of Paris, Tenn introduced Lean into their chemistry-hematology laboratories on a 16-week implementation schedule. Rick Panning, president of Laboratory Services at Fairview, shared his observations of administrators in the eight-hospital health system. The system had regularly undergone quality management training for almost 15 years before implementing Lean. Fairview’s senior health administration turned to Lean as a way to accelerate the results generated by quality projects.
West Tennessee Healthcare of Jackson, Tenn had a similar success story. Gains of 50% in the average turnaround time for inpatient testing, productivity improvement of 60% for laboratory labor, and comparable gains in quality were described by Leo Serrano, administrative director of laboratory services at the Tennessee facility. (See related story on page 44.)
The effectiveness and relevance of Lean management methods in laboratory settings was solidly demonstrated by both presenters. Each of these well-managed hospital laboratories harvested gains of 50% or more in the first 12 to 16-weeks.
Many seminar participants believe that the Lean trend will take hold at a much faster pace than molecular diagnostics.
Contact: Executive War College (800) 560-6363; www.darkreports.com
Congress Addresses Medical Personnel Shortage
In June, Senators Maria Cantwell (D-WA), Jeff Bingaman (D-NM), and Joseph Lieberman (D-CT) introduced the Allied Health Reinvestment Act (S.2491), which is the companion bill to the Allied Health Professions Reinvestment Act (HR.4016) introduced to Congress on March 23.
The purpose of S.2491 is to provide incentives for those seeking to complete education and training in allied health. The bill proposes that the government provide additional funding to ensure that education and training can be provided to allied health students seeking professions in clinical laboratory sciences, medical technology, and cytotechnology.
Congress proposed the bill while highlighting such findings as the increased demand for acute and chronic health care services among the general and aging population. The bill also touched on the increase in medical errors and the role the national personnel shortage is playing in the mounting number of reported cases. Additionally, Congress found that many allied health education programs are facing significant economic pressure that could force their closure due to an insufficient number of students.
Though there are several key differences between the two bills, HR.4016 and S.2491 focus on many of the same concepts and proposals. Much like HR.4016, the new S.2491 bill provides for the development of public service announcements that promote allied health professions and encourage individuals to enter the profession. Both bills include provisions for scholarships in exchange for a service commitment. Scholarship recipients must agree to work for a specified period of time at a health care facility with a critical shortage. S.2491 stresses a service commitment in rural and other medically underserved areas with allied health personnel shortages. Both bills contain an allied health professions faculty loan program that would establish student loan funds at any institution of higher learning to increase the number of qualified allied health professionals and faculty. And both bills provide for education grants and contracts to be awarded for expanding enrollment in allied health education programs and providing education in new technologies that include distance learning methodologies.
Unlike HR.4016, S.2491 specifically states that it will provide grants for allied health recruitment programs and other eligible entities to increase allied health educational opportunities. The bill will provide funding to health career academies that facilitate the entry of students into health care professions. The funding is expected to enhance patient care delivery systems at these facilities by promoting the involvement of allied health professionals in organizational and clinical decision making.
S.2491 also will provide funding to develop models of best practices and innovative strategies for the retaining allied health professionals.
Contact: CLMA (610) 995-9580
|Abbott Secures Contract with Red Cross for Blood Screening Test
Under the terms of contract signed between Abbott Laboratories and the American Red Cross, Abbott will supply the organization with the hepatitis B surface antigen (HbsAg) assay, in addition to continuing to supply the test for HIV-1/ -2 antibodies.
Approximately 8 million volunteer blood donors give about 15 million units of whole blood each year in the United States. The American Red Cross supplies nearly half of the nation’s blood supply to patients in more than 3,000 hospitals.
“We’re pleased that the Red Cross has selected our hepatitis B test for use in their laboratories,” says Joseph Nemmers, senior vice president, diagnostic operations, Abbott Laboratories. "This contract amendment is testament to our mutual commitment to ensuring the safety of the blood supply."
Contact: Abbott Laboratories (800) 323-9100; www.abbott.com
Lupus Foundation of America Announces New Research Support Initiative
The Lupus Foundation of America (LFA) has launched an initiative aimed at removing the barriers that have obstructed progress on research of lupus, an autoimmune disease that affects the lives of an estimated 1.5 million Americans.
“The fact that there have been no new drug therapies for lupus in 30 years underscores the need to address and answer the questions that have impeded the forward progress of clinical trials and the development of new medications to treat lupus,” says Sandra Raymond, president and chief executive officer of the LFA.
The 5-year research support program will help to accelerate the pace of medical discovery in lupus with a goal of making clinical trials more feasible.
“We want to encourage pharmaceutical and biotechnology companies to make substantive investments to find the cause and cure for lupus,” says Joan Merril, MD, LFA’s medical director. "We need to address the gaps in understanding of the incidence and prevalence of lupus to heighten public and private sector interest and investment in lupus, and to stimulate new approaches to the diagnosis and treatment of the disease."
In addition to efforts put forth by the new initiative, the LFA will continue to expand its year-round federal and grassroots advocacy efforts to support increases in congressional appropriations for research on lupus, and to influence a national lupus research agenda. The organization also will continue to support young scientists through its fellowship program and fulfill the commitments that it has made to support young researchers. According to sources from LFA, the organization has awarded 350 Young Investigator grants to researchers at 81 academic institutions throughout the US.
“The LFA plans to facilitate extensive collaborations between Congress, the NIH, and the nation’s leading pharmaceutical and biotechnology companies to achieve the level of focus for lupus research that is required to bring about a good quality of life for individuals suffering from the disease,” adds Raymond.
Contact: Lupus Foundation of America (202) 349-1155; www.lupus.org
FDA Clears New Innovative Drugs
The FDA recently cleared a new laboratory blood test that will increase the ability of doctors to predict the risk of coronary heart disease (CHD).
The test, being referred to as PLAC, works by measuring the enzyme lipoprotein-associated phospholipase A2. The enzyme is made by a type of white blood cell called macrophage, which releases phospholipase A2 into the blood when a person has CHD.
The FDA cleared the test based on results of a large, multi-center epidemiologic study sponsored by the National Heart, Lung, and Blood Institute. The 1,348 patients involved in the study were free from CHD when the study began and were followed to monitor development of the disease for 9 years. The greatest increased risk was found in patients with high PLAC test results and LDL cholesterol levels lower than 130 mg/dL.
The PLAC test is not a stand-alone test for predicting CHD. Instead, it provides supportive information when used with clinical evaluation and other tools for patient risk assessment.
The FDA also has approved a non-invasive test system called NIOX (nitric oxide test system) to measure the concentration of nitric oxide in exhaled human breath. The test system is expected to help make it easier for doctors to monitor patients’ asthma.
Physicians use the device in their office to evaluate a patient’s response to ani-inflammatory treatment. A decrease in exhaled nitric oxide concentration suggests that the anti-inflammatory treatment may be decreasing the lung inflammation associated with asthma. Recent evidence has shown that nitric oxide levels are increased in the breath of people with asthma and that changes in nitric oxide levels may indicate whether or not treatment for asthma is working.
The NIOX test system combines equipment that detects nitric oxide and analyzes exhaled breath with a special computer system. Patients place the mouthpiece over the mouth and inhale the nitric oxide-free air to total lung capacity, then slowly exhale into the mouthpiece. The mouthpiece is connected by a breathing tube to the computer, and the nitric oxide concentration is displayed immediately on the computer screen.
The FDA cleared the NIOX system based on clinical studies conducted by the manufacturer. The studies monitored 95 patients, both adults and children age 4 years and older with confirmed diagnosis of asthma. The patients were tested with the NIOX system before they began drug treatment and again 2 weeks later. The studies were conducted at nine medical centers in the United States, and the results showed that most patients had a 30% to 70% decrease of nitric oxide levels after 2 weeks of treatment with inhaled steroids. In this study, elevated nitric oxide levels above 30 parts per billion correlated with moderate to severe asthma.
Contact: (800) 892-1400; www.aacc.com
Scientists Discover Promising Compound to Protect Against SARS
Scientists from the New York Blood Center’s Lindsley F Kimball Research Institute have identified a new peptide that is believed to protect patients from the SARS virus infection.
"The delivery of this new anti-SARS virus peptide enables us to develop specific antiviral drugs for saving the lives of people infected by the SARS virus," says Dr Shibo Jiang, head of the Viral Immunology Laboratory at the Lindsley F Kimball Research Institute. "Additionally, we hope to prevent the virus from ever reaching epidemic proportions."
The ability to identify the anti-SARS virus peptide was made possible by research gained from the discovery of a potent anti-HIV peptide a decade ago. In the early 1990s, scientists working on the project discovered a very potent anti-HIV peptide, which opened a new avenue for developing novel fusion inhibitors against enveloped viruses that share a similar fusogenic mechanism such as HIV, Ebola virus, influenza viruses, respiratory syncytial virus, and the measles virus. Scientists working on the project plan to design and synthesize more potent anti-SARS virus peptides as drugs in the form of nasal sprays or inhalation formulations for early-stage treatment of SARS, as well as virus infection and prevention.
Contact: New York Blood Center (800) 933-2566; www.nybloodcenter.org
FDA Makes Final Ruling on Bar-Code Labeling
The Food and Drug Administration (FDA) has released its final rule on bar-code label requirements for human drug and biological products. The ruling calls for the inclusion of linear bar codes on most prescription drugs and advocates the use of health industry bar code (HIBC) labeling standards to aid in the reduction of medical errors.
The FDA ruling incorporates changes to the originally proposed language that required exclusive use of retail-based standards. The changes are based on a review of numerous comments from the industry that raised concerns regarding the exclusion of HIBC standards.
The standards were developed when it became apparent that the existing retail-based bar code standards were inadequate for the specific applications and needs of a health care environment. The all-numeric retail standards, developed for the point of sale needs of retailers, have been dissipating within the health care industry since users realized the system did not adequately address patient and consumer safety concerns.
Today’s HIBC standards employ an alphanumeric data structure considered by many industries to be an inherently safer method of encoding data. The FDA’s bar-code rule is anticipated to prevent nearly 500,000 adverse events when fully implemented. For more information regarding the HIBC standards, visit www.hibcc.org.
Contact: Health Industry Business Communications Council (602) 381-1091
Bayer Diagnostics Expands Research Strategies
The diagnostics division of Bayer Healthcare has received CE Mark certification for its genotypic IIV resistance-testing product, the TRUGENE® IIIV-I genotyping kit. The FDA-approved test is the first commercial IIIV resistance product to achieve the CE Mark certification under European In- Vitro Diagnostic Directive (IVD).
The CE Mark recognition indicates that a test has met the requirements of the IVD Directive, allowing for commercial distribution within the European Union for patient testing. The IVD Directive ensures that only safe and functional products are sold in the European market, with clearly outlined regulations regarding manufacturing, import, and commercialization.
The TRUGENE IIIV-1 genotyping kit is a DNA sequencing assay for the detection of IIIV genomic mutations that make specific types of antiretroviral drugs ineffective. The assay is for use in the therapeutic management of IIV-1 infected individuals as an aid in monitoring and treating IIIV-1 infections.
According to sources at Bayer, meeting the CE Mark certification standards will enable the company to supply its products across Europe, providing physicians with access to advanced clinical information in the field of IIIV resistance.
Bayer also has entered into a number of agreements with pivotal companies and organizations in the industry in order to increase productivity and product exposure.
The company has joined forces with Novation to provide members of VHA Inc and the University HealthSystem Consortium (UHC) access to its full line of blood gas systems. Throughout the duration of the 3-year contract, Bayer will make available its full line of blood gas products, which includes the Rapidpoint® series system, the Rapidlink® information management system, and the Rapidlab® 800, 348, and 248 analyzer series.
Axeda Systems Inc has licensed its DRM™ system to Bayer for the use in proactive, remote servicing of Axeda’s ADVIA Centaur® Immunoassay System and other laboratory instruments. According to Bayer, remote servicing will reduce unnecessary time spent by lab technicians troubleshooting products. The Axeda DRM system lets instrument manufacturers monitor, manage, and service devices deployed at remote customer sites from anywhere in the world. The system allows the secure transmission of instrument data by way of the Internet from remote equipment to service representatives, alerting them if a device is operating irregularly.
Bayer has also entered into a worldwide agreement with Amersham for joint development of assays and instrumentation in the field of human immunodeficiency virus (HIV) sequencing as well as sequencing of other important infectious disease-causing pathogens.
Under the terms of the agreement, Amersham will supply a modified version of its existing MegaBACE gene sequencer instruments and Bayer will develop sequencing assay applications for Amersham’s sequencer. Additionally, Bayer will purchase Amersham’s reagents, including its four-color dyes and proprietary enzymes, as well as other consumables, for current and future assays. Both companies intend to seek approval from the FDA for the MegaBACE instrumentation and disease-specific assays.
Contact: Bayer HealthCare (914) 631-8000