Roche’s WNV Test Identifies Infected Blood
Roche Diagnostics has announced that its TaqScreen West Nile Virus Test has successfully identified a unit of blood with confirmed WNV infection. It was the first instance of human West Nile Virus infection reported in the United States in 2003. The infected blood was intercepted at Gulf Coast Regional Blood Center in Houston, one of the 11 clinical trial sites evaluating the new system. The center supplies more than 2,000 units of blood each day to more than 220 hospitals in Texas.
With the TaqScreen test, Roche introduced the first North American nucleic acid blood-screening system to fully automate specimen processing, amplification, and detection. The test uses Roche’s polymerase chain reaction technology to detect the genetic material of the virus. According to the company, it created the test in less than 9 months to address concerns expressed last year by the US Food and Drug Administration and Centers for Disease Control and Prevention about the potential for an increase in transfusion-related WNV infections during the 2003 mosquito season.
LabCorp and Atherotech to Offer VAP Cholesterol Test
Laboratory Corporation of America Holdings has entered into a marketing and distribution relationship with Atherotech, a cardiodiagnostic company and specialty reference laboratory, to offer its proprietary Vertical Auto Profile (VAP™) cholesterol test. The multiyear agreement includes a provision for the transfer of patented testing technology to LabCorp. Then if certain conditions are met, LabCorp would become the first clinical laboratory licensed to perform the cardiovascular disease risk-assessment assay within its own national laboratory system.
This partnership will ensure broader patient access for Atherotech’s VAP test technology through LabCorp’s sales and distribution network while adding an important test to LabCorp’s current menu of esoteric assays for cardiovascular disease. Atherotech’s VAP test is an expanded cholesterol test designed to improve the identification of those at risk for heart disease. It provides direct, detailed measurements of cholesterol subclasses that play important roles in the development of heart disease.
Westchester Opens Its First Integrated Laboratory System
|White Plains Hospital Center (WPHC) and the Diagnostics Division of Bayer Healthcare LLC have partnered to open a new integrated laboratory system for use in patient diagnostic care, the first in Westchester, NY. The new chemsitry lab, which uses Bayer’s ADVIA® WorkCell modular automation system, has become the only fully automated chemistry lab at any Westchester hospital. The ADVIA WorkCell integrates clinical chemistry and immunodiagnostics into a single automated system. As a result, the hospital’s lab expects to more than double its work output with existing staff. At the same time, patients will now receive test results in a matter of hours, as opposed to a day or more.
“I am very pleased to announce to our medical staff, the great testing capability, expedited testing time, and greater accuracy of our new immuno-chemistry system. This will have a positive impact on patient care at White Plains Hospital,” says Deena Shah, MD, medical director, Department of Pathology and Laboratory Medicine, WPHC.
FDA Clears Test for West Nile Virus
The US Food and Drug Administration has cleared the first test for use as an aid in the clinical laboratory diagnosis of West Nile Virus infection. The West Nile Virus IgM Capture ELISA is intended for use in patients with clinical symptoms consistent with viral encephalitis/meningitis. The IgM Capture ELISA is manufactured by PanBio Ltd in Windsor, Australia.
The new test works by detecting the levels of a particular type of antibody, IgM, to the disease in a patient’s serum. IgM antibodies can be detected within the first few days of the onset of illness, which can assist in diagnosis.
The PanBio assay was evaluated using more than 1,000 samples of patient sera, which were tested at four different clinical sites. The test correctly identified the antibody in up to 90% to 99% of West Nile Virus cases. However, this assay is considered presumptive and should be confirmed by more specific testing because detection of the antibody is not always specific in patients with acute viral infections.
Chinese Government Approves Device to Reduce Airborne Transmission of SARS
RGF Environmental Group’s proprietary Photohydroionization2 Cell has been approved by the SARS Task Force of the Chinese Central Government. The air purification device uses oxidation to destroy airborne bacteria, viruses, VOCs (chemicals), smoke, mold, and odors. The technology used in the PHI2 Cell™ is a high-intensity, broad-spectrum UV light targeted on a hydrated metallic compound target, which creates an advanced oxidation atmosphere.
The approval comes after months of laboratory tests by the government and 150 test sites in the Shanghai subway system. The plan is to install the device in all ventilation, heating, and air conditioning systems of government and public buildings, subways, and airports.
Blueprint Releases Standards for Proteomic Data Management
The Blueprint Initiative research program, led by Principal Investigator Dr Christopher Hogue at Mount Sinai Hospital’s Samuel Lunenfeld Research Institute, has released the complete public database curation standards document in the field of proteomics. The document details the standards and process by which curators are building the Biomolecular Interaction Network Database (BIND.CA).
At the same time, Blueprint released its modular training manual and presentation set, used internally for BIND curator training. The BIND database and its associated software tools are already available free of charge to academics and companies worldwide. This comprehensive repository for biomolecular interaction data includes information on a variety of organisms and facilitates research from at least 16 subdisciplines of the life sciences. This information will help scientists understand how complex molecules inside cells assemble to form living cells, in both healthy and disease states.
Blueprint’s funding is provided by Genome Canada in partnership with the Ontario Research and Development Challenge Fund, the Canadian Institutes of Health Research, and industry partners Sun Microsystems, MDS Proteomics, and Foundry Networks. It covers costs associated with BIND database curation, software development, computer hardware, and networking.
Roche Launches SARS Test
Roche, headquartered in Basel, Switzerland, has released a research product designed to detect severe acute respiratory syndrome (SARS) and increase understanding of its epidemiology. The company reports that the test was developed in only 8 weeks, the shortest development time for a research product at Roche. That achievement was made possible through international collaboration and networking relationships with virology institutes and government agencies, including the Genome Institute of Singapore.
Based on Roche’s patented real-time polymerase chain reaction (PCR) technology, the test was developed using the company’s Light/Cycler instrument and was designed for ease of use by technicians with a variety of training levels. Heino von Prondzynski, head of the Diagnostics Division and a member of the Roche Executive Committee, commented: “Even if the infection rate with the SARS virus is regressive, we do not know if we will have to face another outbreak in the future. In the meantime, researchers will use our product to answer questions still open about the incubation time, the point when patients are most infectious, or how long the virus can survive outside the body.”
New E-Commerce Web Site Provides Diagnostic Products
To offer convenience in shopping and enhanced customer service, Ortho-Clinical Diagnostics has launched [email protected], a new e-commerce Web site at www.orthoclinical.com/buydirect.com. Nearly 500 Ortho-Clinical Diagnostics consumable products are available for sale at [email protected], and customers can access up-to-the-minute shipping status information for each order through a link to the FedEx® Web site.
“[email protected] provides an additional level of service for our US customers,” says Catherine Burzik, president of Ortho-Clinical Diagnostics, Inc. “In addition to the 24-hour ordering from our complete, up-to-date catalog, BuyDirect offers customers access to orders made over the previous 18 months, whether they were made online, over the phone, or through other channels.”
Ortho-Clinical Diagnostics customers in the United States can request an account via the online registration page through the Web site or by calling customer service at (800) 828-6316.
|UK Gains Access to Unbiased Laboratory Testing Results|
|Health-minded consumers in the United Kingdom who seek noncommercial, peer-reviewed information on laboratory testing will soon have access to Lab Tests Online/UK, a version of the Lab Tests Online Web site that currently serves more than 200,000 users a month in the United States.
Through the recent agreement between the American Association for Clinical Chemistry (AACC) and the Association of Clinical Biochemists (ACB), the AACC will license the content of the Web site to ACB, share the technology infrastructure underlying the site, and copromote what both parties hope will be the start of an international network of Lab Tests Online sites. ACB expects to launch Lab Tests Online/UK in 2004.
When AACC first considered exporting the site, a primary concern was the need for an in-country laboratory society or health care organization to take responsibility for translating and adapting the site’s content to the specifics of its country and for keeping the site current. The in-country society, which in this case is ACB, would serve as the publisher of the new site. ACB will adapt the content to the Queen’s English and adjust it to reflect policies and practices in the United Kingdom.
“We think this is a great opportunity to broaden the audience for a highly regarded product aimed at patient education,” says AACC President Sue Evans. “Our arrangement with ACB should become a model for launching sister sites in other countries.”
ACB plans to launch with a reduced version of the site that will focus exclusively on the 150 test descriptions currently available on the original Lab Tests Online. It will add new tests as they are developed and approved for the US site and will also produce new material on tests used in Europe but not yet licensed in the United States.
Lab Tests Online is an award-winning patient education Web site that was launched by AACC and four other professional societies in July 2001 to provide unbiased resources on laboratory testing. Today, 14 professional societies are teamed in the further development and updating of the site content, and more than 25 companies sponsor the site.
LifeScan Promotes Tight Glycemic Control in the ICU
LifeScan Inc, a Johnson & Johnson Company, launched a company-wide initiative to educate hospitals and medical institutions about the benefits of implementing tight glycemic control (TGC) within their organizations. LifeScan will aim to help institutions understand how to implement two changes in protocol designed to improve patient mortality and morbidity rates and quality of care: 1) identifying all ICU patients with elevated blood glucose levels, and 2) tightly controlling those glucose levels with intravenous insulin therapy.
A comparative two-arm study published in The New England Journal of Medicine by Dr Greet Van den Berghe et al, followed 1,548 patients and compared the control group with those whose blood glucose levels were maintained between 80 and 110 mg/dL. For the first time, the study quantifies the benefits of TGC within institutional ICU units.
“There may be a significant financial impact of tight glycemic control,” says Dr Daniel Hilleman, professor of medicine at Creighton University and member of the Cardiology Editorial Advisory Board. “An example of the economic impact was previously quantified in a study published by Dr Furnary et al in 1999. These authors believe that, based on their experience and their own institution’s prevailing charges, tight glycemic control protocols in the United States alone could save an estimated $51.7 million on hospital charges related to deep sternal wound infections. This type of information would be of interest to CFOs and the pharmacy and therapeutics committees of any institution across the United States.”
Among the benefits revealed in these studies are mortality from bacteremia reduced 42%, long-stay ICU mortality reduced 57%, and ICU stays greater than 5 days were reduced 24%. In addition, the number of patients who required antibiotics for at least 10 days was reduced by 36%, while septicemia was reduced by 46% and overall in-hospital mortality was down 34%.
“In recent years, the rising costs of health care, shortage of nursing staff, and reductions in reimbursement have forced institutions to seek out alternatives to reduce costs while improving the quality of patient care,” says Karen McCormick, vice president, Institutional and Cardiovascular Units, LifeScan, Inc. “LifeScan is committed to educating institutions about tight glycemic control and the resulting improvements in the health of their patients and institution.”
ITC to Market IRMA in Fourth Quarter 2003
Upon the recent announcement to acquire the IRMA (Immediate Response Mobile Analysis) Blood Analysis System from Diametrics Inc, International Technidyne Inc (ITC) stated it will begin to market IRMA with its Hemochron POC blood coagulation system in the fourth quarter of 2003 through an expanded sales force and select distributors.
“Despite its high quality, awareness of IRMA is relatively low in the marketplace,” says Lawrence Cohen, president of ITC. “Our goal, therefore, is to increase market share for IRMA offerings by backing their performance and technical leadership with outstanding sales, marketing, and customer service initiatives.”
While ITC’s Hemochron has been a market leader in testing blood coagulation, the portable IRMA system provides time-critical blood analysis information. Based primarily on electrochemical sensor technology, it features an interactive touch screen that prompts users through test procedures. Results are available in 90 seconds for test panels in nine test cartridges to measure blood gases, electrolytes, chemistries, and hematocrit. A separate module performs blood glucose strip tests. IRMA also features built-in quality control features and a data-management system that can be linked with the central laboratory information system.
“IRMA has the full panel of blood gas and electrolyte tests needed for POC use, while Hemochron offers the full breadth of POC coagulation tests,” says Cohen.
According to Cohen, ITC plans to extend its sales force and technical support staff and will retain key Diametrics personnel in research and development and manufacturing.
Thermo Electron Unifies Its Product Lines
As a result of efforts to simplify company structure and eliminate disparate branding, Thermo ALKO, Thermo BioStar, Thermo Clinical Labsystems, Thermo DMA, Thermo Finnigan, and Thermo Trace will now be known simply as Thermo Electron Corporation. The combined group made its public debut under its new identity at the American Association for Clinical Chemistry show in Philadelphia, July 22–24.
Consequently, customers, who in the past purchased the TSQ Quantum mass spectrometer from Thermo Finnigan, will now have the option to purchase from the Finnigan TSQ Quantum family of triple-quadruple mass spectrometers from Thermo Electron. Similarly, Thermo Electron will also now sell the BioStar range of rapid diagnostic kits, the ALKO range of blood gas and electrolytes consumables, and for customers outside North America, the Konelab range of clinical chemistry analyzers.
"This integration of company names is in line with our ‘One Thermo’ strategy," says Marc Casper, president of Thermo Electron’s Life and Laboratory Sciences sector. "We believe that leveraging the resources of one integrated company will ultimately benefit our customers through access to enhanced technical support and a streamlined order process, for example. For the past two years, we’ve been simplifying the company, and this is just another logical step in that important process."
Boston Biomedica Introduces WNV Quality Control Product
Boston Biomedica Inc (BBI) has introduced a new quality control product designed to monitor laboratory testing for West Nile Virus (WNV) infections. Accurun 165 West Nile IgM and IgG Positive control enables hospital and clinical laboratory personnel performing diagnostic tests to check the validity of test results that detect antibodies to West Nile Virus. It is the company’s fifth WNV quality control product.
Boston Biomedica also recently launched West Nile Virus Nucleic Acid Positive (Accurun 365) and Negative (Accurun 865) controls for use in blood banks for quality control of donor screening tests. Blood banks began screening donated blood for evidence of West Nile Virus on July 1.
Since November 2002, BBI has supplied quality control materials to researchers and blood banks involved in developing tests to screen donated blood for evidence of the virus. In 2002, there were more than 4,000 cases of WNV infection, resulting in 284 deaths, in the United States.
Ortho-Clinical Diagnostics Submits 510(k) Filing for Chemistry System
Ortho-Clinical Diagnostics, Raritan, NJ, a Johnson & Johnson company, has been informed that its filing of the Premarket Notification 510(k) for the VITROS® 5,1 FS Chemistry System has been received by the US Food and Drug Administration’s Center for Devices and Radiological Health.
The VITROS 5,1 FS Chemistry System is designed to enhance ease of use as well as increase the onboard test menu. It will integrate up to 80 routine and special chemistry assays through the use of Intelligent Parallel Processing™. The system will feature the company’s MicroSlide ™ Technology, Intellicheck Technology™ for advanced clot and bubble detection, MicroSensor™ Technology for fully automated sample interference monitoring, and the new MicroTip™ Technology, which eliminates the water, plumbing, drains, fixed probes, and mixing assemblies characteristic of alternative technologies.
Bayer Receives FDA Clearance for Automated BNP Assay
The Diagnostics Division of Bayer HealthCare LLC, a member of the Bayer Group, has received US Food and Drug Administration (FDA) clearance for its BNP (B-type natriuretic peptide) assay, a fully automated test for use as an aid in diagnosing heart failure. The BNP assay expands the cardiovascular panel of CK MP, Myoglobin, Troponin I, and Homocysteine offered on Bayer’s ADVIA Centaur Immunoassay system. The BNP assay has a greater than 99% negative predictive value in ruling out heart failure, with total precision of 3.0% to 5.0% across the dynamic range. BNP results are ready in minutes, requiring less hands-on labor and reducing human error associated with manual testing.
Roche Diagnostics Launches Consulting Suite
To provide innovative technical and consultative solutions to health care providers and consumers, Roche Diagnostics, Indianapolis, has developed Healthcare Solutions, a group of technological and professional services. With Healthcare Solutions, hospitals, laboratories, and physicians have access to actionable solutions to the challenges of cost management, business growth, information technology, and large-scale program management.
For its Cost Management Value Improvement Program, Healthcare Solutions formed an exclusive alliance with TISMO® Inc, a provider of activity-based costing solutions to the health care industry. Through this agreement, Roche’s Healthcare Solutions personnel will have exclusive use of the CostXplorer™ Activity Based Costing tool to help customers improve efficiencies and productivity throughout their organization. Other cost-management solutions will focus on areas such as optimal facility configuration and design, performance metric targeting, and Six Sigma principles for leadership and education.
Business Growth Value Improvement Programs will focus on expanding business opportunities through strategic planning, outreach marketing, and a laboratory-to-physician Web portal, CareEvolve™. Information Technology Value Improvement Programs will assist in assessing, selecting, integrating, and connecting information technology solutions across the hospital, laboratory, and physician settings. In addition to these programs, Healthcare Solutions will provide large-scale project management support from certified project-management professionals.
“By leveraging our existing expertise in diagnostics, recruiting top consulting talent from the health care industry, and forming strategic relationships with TISMO, CareEvolve, and others, we have created a powerful, innovative set of solutions for our customers,” says Raymond Young, vice president, Services, Roche Centralized Diagnostics. “This new approach provides diagnostic laboratories with a better alternative to large-scale consulting firms, niche health care consulting organizations, and independent industry consultants.”
ABMC Receives FDA 510(k) Clearance for New Rapid Tec Tests
American Bio Medica Corporation has received 510(k) clearance from the US Food and Drug Administration for new tests in its Rapid Tec product series that includes assays for methamphetamines and opiates at a 300 ng cutoff level. The company also launched Rapid Tec 5, which tests for THC, cocaine, amphetamines, benzodiazepines, and opiates (300 ng) for forensic use. Rapid Tec offers the chemistry to detect more than one class of drug on a single drug-testing strip.
“We saw a specific market need for an expanded menu of drug tests to include methamphetamines and opiate detection at 300 ng cutoff levels, and we have the in-house ability to develop products to meet these needs," says Gerald A. Moore, chairman and chief executive officer of ABMC. “ABMC is carving out a leading market position by offering a wider range of tests and also offering the flexibility to combine various tests to meet the exact needs of different programs.”
|Roche Plans HCV Educational Program for Laboratories|
|Roche Diagnostics Corporation, Indianapolis, has announced plans for an educational program on hepatitis C (HCV) for laboratories and their customers. The program will include two components: 1) printed materials to help laboratories present information to health care providers, and 2)an information-sharing process to help identify physicians who are interested in HCV diagnostic and treatment options. As part of this campaign, Roche will sponsor continuing medical education-accredited courses on HCV-related topics.
HCV is the most common blood-borne infection in the United States with approximately 4 million infected individuals.
|West Nile Virus Diagnostic Kits Submitted to FDA for 510(k) Clearance|
|Focus Technologies has completed clinical trials on its West Nile Virus IgG and IgM ELISA diagnostic kits and filed a 510(k) application with the FDA. The products are based on protein antibody technology licensed from the Centers for Disease Control and Prevention (CDC).
West Nile Virus has emerged in recent years in temperate regions of Europe and North America to present a serious threat to public and animal health. The most serious manifestation of the virus infection is fatal encephalitis. The disease is transmitted by an infected mosquito, not directly from humans or animals. Overall case-fatality rates in severe cases are about 10%. Laboratory diagnosis of the infection is through detection of IgM and/or IgG antibodies to West Nile Virus in serum. Viral detection using PCR is also available.
Last April, in an effort to expand access to West Nile Virus testing throughout the United States, Focus Technologies began offering analyte specific reagent (ASR) products to public health departments, commercial laboratories, and major hospitals.
“We are eager to receive marketing clearance on our West Nile Virus ELISA kits so that more facilities in the United States will be able to conduct testing for this disease,” says Charles C. Harwood, Jr., CEO and president of Focus Technologies.
Tecan US and GE Medical Systems Form Strategic Alliance
Tecan US, Durham, NC, has announced a strategic alliance with GE Medical Systems for one of Tecan’s automation solutions—the front-end Genesis FE500 Workcell. The two companies will enhance clinical diagnostics lab output using Tecan’s robotic equipment to enhance sample flow coupled with GE Medical Systems’ customer service.
The Genesis FE500 is a modular, compact, front-end automation workcell that combines all preanalytical functions, including presorting, centrifugation, volume check and clot detection, decapping, secondary tube labeling, aliquoting, and destination sorting into analyzer racks from a variety of manufacturers.