Wampole Laboratories Signs Agreement to Acquire Exclusive US Distribution Rights for HIV Test
Wampole Laboratories, a division of Inverness Medical Inc, has entered into an agreement with Efoora Inc of Buffalo Grove, Ill, for exclusive US distribution rights to the Efoora Rapid HIV test. Wampole Laboratories of Princeton, NJ, provides diagnostic tests for a broad range of infectious diseases and markets products to both the laboratory and point-of-care markets. Efoora is a developer and manufacturer of diagnostic products, encompassing both lateral flow and biosensor diagnostics.
Clinical trials for the Efoora Rapid HIV test were completed in March 2003, and the test is now pending FDA clearance with the intent to also gain a CLIA waiver for whole blood. A CLIA waiver will allow on-site testing in doctors’ offices and point-of-care settings such as emergency rooms.
The test uses a three-step format that provides readable, color results using either serum, plasma, whole blood, or fingertip whole blood. Total hands-on time is approximately 1 minute, and test results are available in 20 minutes or less. On-site test results in only 20 minutes allow for crucial medical decisions to be made and, if necessary, counseling and treatment to be started without delay. The Efoora Rapid HIV test is based on immunochromatography using Inverness’s patented rapid test technology, resulting in exceptional performance claims for both sensitivity (99.8%) and specificity (99%).
Under the terms of the agreement, Wampole Laboratories will have exclusive distribution rights to the test in the United States, with the possibility of extending its rights to other markets.
Doctors Laboratory to Offer Atherotech’s VAP Expanded Cholesterol Test
Doctors Laboratory Inc will offer the VAP™ (Vertical Auto Profile) cholesterol test as part of its expansive menu of diagnostic services. The test, developed by Birmingham, Ala–based Atherotech, will be available to customers of Doctors Laboratory’s 23 testing facilities in Georgia, Florida, and Alabama.
The VAP test goes beyond measuring total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides. It provides detailed measurements of cholesterol subclasses that play important roles in the development of heart disease. Studies have shown that patients with elevated Lp(a), for example, are at 70% greater risk of developing premature heart disease. The test also provides a direct measurement of LDL cholesterol and identifies more than 90% of patients at risk for heart disease.
|Dade Behring Releases Survey on the Perception of the Diagnostic Industry|
|Dade Behring has released the findings of its benchmark survey on the diagnostic industry’s reputation among US consumers, health care professionals, and others. The intent of the survey, which was conducted by an independent research firm, was to develop further understanding of the expectations of consumers and health care and industry professionals so that they can be addressed by the industry.
Overall, the data demonstrate that despite a level of understanding that currently exists, there is ample opportunity to build on increasing appreciation for the critical role that diagnostics can play in improving the quality of health care delivery.
The survey indicated that half of the consumers interviewed believe that the diagnostics industry has a strong impact on the quality of their health care. More than half believe that laboratory testing professionals have a “strong impact” on the quality of health care they receive, while more than four out of five (84%) say that early-stage testing to assess one’s risk of developing a disease is important.
“It is our hope that these survey results will start a dialogue to further educate both consumers and health care professionals about the value of diagnostics and the importance of utilizing valuable tests to predict, prevent, and help treat disease,” says Jim Reid-Anderson, chairman, president, and CEO,
|Data Innovations Adds Global Business Partners|
|Lab management firm Data Innovations, through its international subsidiaries, has signed three new business-partner agreements. The new business partners are LabExpert GmbH, which develops, sells, installs, and supports a number of medical information systems in Germany; Velez Lab y Cia of Colombia, a provider of immunology diagnostic products and biochemical, coagulation, plasma protein, connectivity, and quality control solutions; and Marcelo Botelho & Associados, a 13-year-old Brazilian software company.|
Focus Technologies to License ViroNovative’s Human Metapneumovirus
Focus Technologies of Herndon, Va, has entered into a semi-exclusive agreement with ViroNovative BV to become the first laboratory in the United States to license ViroNovative’s rights to nucleic acid diagnostic testing for human metapneumovirus (hMPV). Human metapneumovirus is a newly discovered human viral respiratory pathogen that causes a spectrum of respiratory problems ranging from asymptomatic infection to severe bronchitis. Preliminary studies in the United States indicate that the incidence of hMPV among hospitalized patients with respiratory symptoms varies between 7% and 11%.
“This new testing capability for hMPV fits well with our extensive menu of infectious disease assays for new or emerging pathogens,” says Charles C. Harwood, Jr, president and CEO of Focus Technologies. “Bringing a nucleic acid testing service to the market will help physicians in the United States to properly diagnose children with this serious respiratory disease.”
Seroprevalence studies revealed that 25% of all children 6 to 12 months of age who were tested in the Netherlands had detectable antibodies to hMPV; by age 5, 100% of patients showed evidence of past infection. Focus’s nucleic acid test will not only be the first that detects hMPV, but it will allow physicians and researchers to differentiate hMPV infections from those caused by human respiratory syncytial virus (hRSV), a virus that causes similar serious disease in young children as well as immunocompromised and elderly adults. While the disease syndromes caused by hMPV and hRSV are clinically indistinguishable, the two viruses are not close genetic relatives. Vaccines and other therapies to treat hMPV are currently being developed.
|CILS Creates Barcode Bureau Division for Hospitals and Labs|
|Computer Imprintable Label Systems (CILS) Ltd has created a Barcode Bureau Division in response to the growing demand for durable bar-code labels in hospitals and laboratories. The division provides expertise in all bar-code fields and symbologies, including high-density Code 128 for bar-coding of microplates. The CILS Barcode Bureau Division is capable of handling complex sample and patient ID variable data fields. CILS prints and verifies each label individually, maximizing first-time readability and eliminating waste.
Bar-coding is now available on the full range of CILS labels, which stick to difficult surfaces, including tubes, vials, slides, petri dishes, microplates, and other general labware.
GE Medical Systems Completes Acquisition of Triple G® Systems Group
GE Canada Enterprises Company (GE), a wholly owned subsidiary of General Electric Company, has completed the acquisition of Triple G, developer of medical laboratory information systems. GE acquired all of the issued and outstanding common shares of Triple G for $3.30 (Canadian) per share, payable in cash.
“With Triple G’s advanced lab information systems, GE will be able to help clinicians provide safer patient care through a paperless process that automates laboratory workflow and allows for faster, more accurate ordering and reporting of patients’ lab information,” says Dow Wilson, president and CEO of GE Medical Systems Information Technologies.
Triple G laboratory information systems are licensed by more than 110 health care facilities, representing more than 450 clinical laboratories in the United States, the United Kingdom, Canada, and the Asia Pacific.
Labconco to Host Seminar on Laboratory Design
Labconco Corporation of Kansas City, Mo, is hosting a seminar for individuals involved in laboratory planning, including lab managers, science department heads, safety officers, facilities planners and managers, architects, and laboratory equipment planners.
The seminar, “Practical Approach to Laboratory Design,” will be held at Labconco’s headquarters in Kansas City on October 28 and October 29. The agenda will include fume-hood demonstrations in Labconco’s airflow-testing laboratory where various laboratory conditions can be simulated. Guest speakers will address trends in lab planning and design, vivarium planning, Biosafety Level 3 facility planning and design, renovation versus new construction, and cost-effective approaches for new lab construction. Twelve AIA/CES learning units with Health, Safety, and Welfare credits will apply.
ECRI Launches Online Hazard and Recall Management System
ECRI has launched the ECRI Alerts Tracker, an online hazard and recall management system. The nonprofit international health services research agency developed the new system to help hospitals handle the more than 500 recalls issued by medical-device manufacturers each year, as well as hundreds of other hazard and safety notices.
The ECRI Alerts Tracker system relays hazard and recall alerts throughout the hospital via automated weekly emails containing information customized to each staff member’s clinical/professional area and individual preferences. Hospital administrators and patient-safety professionals can access online real-time usage reports and to-do lists that show individual and hospital-wide actions taken to resolve critical issues, allowing easier compliance with Joint Commission on Accreditation of Healthcare Organizations requirements for managing hazard and recall information.
The content for ECRI alerts is drawn from a variety of national and international patient-safety organizations, ECRI product evaluations, member hospital reports, and accident and forensic investigations, in addition to FDA data and manufacturer notices. ECRI verifies the recall information, clarifying complex language and product names if necessary, and then adds expert advice about the steps hospitals should take to resolve the recall or hazard alert.
ECRI Alerts Tracker is available only to members of ECRI’s Health Devices System, Health Devices Gold, and SELECTplus™ health care technology advisory services. Included in a 1-year ECRI Alerts Tracker license are two interactive training sessions to ensure that users can effectively implement the product throughout the hospital.
FDA Clears New Urine Test for Detection of Kidney and Cardiovascular Diseases
AusAm Biotechnologies Inc’s Microalbumin Plus has received marketing clearance from the Food and Drug Administration. Microalbumin Plus is a significant advance in the diagnosis of kidney and cardiovascular diseases through urine testing. Urine testing can detect an excess of the protein albumin, a condition called microalbuminuria. Excess urinary protein indicates the beginning stages of kidney and cardiovascular diseases. Microalbumin Plus, an accurate and quantitative test, detects all intact urinary albumin, thereby alerting physicians to the onset of these diseases much earlier than other tests.
“Chronic kidney disease affects one in nine American adults and usually does not present symptoms until damage to the kidneys has already begun,” says Brian Pereira, president of the National Kidney Foundation. “Early identification of the disease is key to stopping or delaying disease progression and saving more lives.”
Microalbumin Plus was developed as a step-change improvement over conventional tests for urinary protein. The Microalbumin Plus test uses common laboratory equipment to separate albumin from the other compounds in urine and directly determine its true quantity. This provides the most accurate reading available.
|Bayer Diagnostics Automates Test for HIV|
|The Diagnostics Division of Bayer HealthCare LLC has announced the availability of the HIV 1/O/2 assay on its automated immunoassay platform, the ADVIA Centaur® immunoassay system. The assay, which is not available in the United States, aids physicians in the diagnosis of patients infected with the human immunodeficiency virus (HIV) types 1 and 2.
The HIV 1/O/2 assay is developed, manufactured, and sold by Bayer Diagnostics for Ortho-Clinical Diagnostics under an agreement entered into with Bayer, Ortho, and Chiron Corporation in 2001. Under the terms of the agreement, Bayer will not represent the product for blood or plasma screening.
The ADVIA Centaur HIV 1/O/2 assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to HIV in human serum and plasma. The presence of antibodies to HIV indicates that an individual may have been infected with HIV or may be capable of transmitting HIV infection. The ADVIA Centaur HIV 1/O/2 assay detects HIV types 1 and 2, including HIV-1 Group O, which is part of the worldwide health care standards for detecting all known types of HIV infection.
“The addition of the HIV assay strengthens Bayer Diagnostics’ infectious disease portfolio by expanding our ability to offer customers a comprehensive, fully automated test menu,” says Hans Hiller, PhD, senior vice president, Bayer Diagnostics. “In addition to a fully automated panel for Hepatitis B and C, the HIV test will allow laboratories to routinely provide these specialized test results to aid physicians in making treatment and management decisions.”
Labtronics BV Expands European Office
The European office of Labtronics BV has moved to a larger facility in Gouda, The Netherlands. The move is expected to allow Labtronics to provide improved support and training facilities for its growing customer base.
The growth of the company has been fueled by its success in implementing major LIMS interfacing projects using LimsLink and LimsLinkCDS and its leadership in introducing NEXXIS as an integration solution for RS232–based instruments according to Robert Pavlis, president of Labtronics Inc.
New Lab Technology Conference Planned
The Association for Laboratory Automation (ALA) will launch a new conference, ALA LabFusion 2004, June 12–16, 2004, in Boston. Coincidentally, Zymark Corporation will hold its final International Symposium on Laboratory Automation Robotics (ISLAR), October 19–22, 2003. Zymark will be the primary sponsor of ALA LabFusion 2004.
ALA LabFusion 2004 will offer more than 100 educational sessions and an exhibit area that focuses on emerging laboratory technologies in the life sciences industry. “Researchers attending ALA LabFusion 2004 will be exposed to new research and assays that can lead to new discoveries,” says Tony Beugelsdijk, PhD, MBA, of Los Alamos National Laboratory.
Zymark president and CEO Kevin Hrusovsky says, “After 21 years of unprecedented success with ISLAR, we welcome this natural transition to the ALA. LabFusion will bring together the laboratory automation community in the East and create untold synergies and collaborations. We also are excited about our new role as the primary sponsor of ALA LabFusion 2004.”
ALA currently produces a West Coast conference, LabAutomation, held annually in February in San Jose, Calif. The programs of the LabAutomation conference in the West and the ALA LabFusion conference in the East will be tailored to the interests of each region.
FDA Proposes New Rule for Labeling Blood
The Food and Drug Administration (FDA) has proposed a new rule to revise the labeling and storage requirements for blood and blood components, including source plasma. The new rule would combine, simplify, and update regulations related to blood container labeling and to the storage and shipping temperatures of frozen blood components. Among changes proposed would be a labeling system using machine-readable information that would be acceptable as a replacement for the “ABC Codabar” system for labeling blood and blood components.
The FDA is taking this action as part of its “Blood Initiative” to review and, as necessary, revise its regulations, policies, guidelines, and procedures related to the licensing and regulation of blood products.The proposed rule is intended to help ensure the continued safety of the blood supply and consistency in container labeling and storage temperatures.
|FDA to Expedite Approval of Medical Devices|
|The Food and Drug Administration (FDA) has announced a new goal of reducing the amount of time that premarket approval (PMA) applications for medical devices remain under review. The goal is to reduce by 30 days the review time the FDA requires to approve expedited and regular PMAs. The FDA will work with applicants to improve the quality of applications submitted. In addition, the agency will work to improve the process for providing and reviewing evidence on the safety and effectiveness of new medical devices.|
Radiometer America Signs Second Blood Gas Agreement With Premier
Radiometer America Inc of Westlake, Ohio, has signed an agreement with the group purchasing division of San Diego–based Premier Inc to offer its blood gas instruments and related products and services to Premier member hospitals and health care organizations. The 2-year contract is the second blood gas agreement between Radiometer America and Premier.
Radiometer America will supply its ABL™ 700 Series blood gas analyzers, ABL77 point-of-care analyzer, and TINA™ transcutaneous monitors, including Radiometer’s new TCM™ monitor, to Premier member organizations. Related accessories, software, and services covered by the agreement include Radiometer’s AutoCheck™ automated quality control module, RADIANCE™ STAT Analyzer Management System, Radiometer’s safeCLINITUBES™ plastic capillary blood samplers, and a recently introduced CEU–accredited training program.
Hycor to Develop and Supply Autoimmune Tests for Beckman Coulter
Hycor Biomedical Inc and Beckman Coulter Inc have signed a multiyear, exclusive, worldwide agreement under which Hycor will develop and supply a broad menu of automated tests for certain autoimmune disease markers on Beckman Coulter’s Access® Immunoassay platforms, including the UniCel DxI™ 800 and the SYCHRON LX® i 725. The tests, developed using Beckman Coulter’s magnetic particle chemiluminescence technology and Hycor’s library of antigens and antibodies, will accelerate the aggressive immunoassay test menu expansion initiative Beckman Coulter implemented earlier this year.
“By automating and consolidating autoimmune testing on our Access system and differentiating our menu offering through this agreement with Hycor, we have the leverage we need to enter and take significant market share of the high-volume autoimmune disease segment,” says Michael Whelan, vice president of Beckman Coulter.
“Many high-volume clinical laboratories offer autoimmune testing using manual or semimanual methods,” says J. David Tholen, Hycor’s president and CEO. “By partnering with major manufacturers of automated immunoassay systems, like Beckman Coulter, we can offer our customers an extremely effective automated immunoassay solution that will eliminate their current inefficient workstations and expand both our and Beckman Coulter’s opportunity for the sale of new products.”
Panasonic Moves Into Drug-Discovery Market with Nanotechnology Startup
Panasonic is entering the drug-discovery instrument market with a first device that will be sold in partnership with a California nanotechnology startup.
Panasonic’s parent company, Osaka-based Matsushita Electric Industrial Co Ltd, will build the device–an optical scanner used to quickly read the results of laboratory drug tests. The company will market the scanner in partnership with Quantum Dot Corporation of Hayward Calif, a five-year-old private company that developed the technology behind the instrument.
The new Mosaic Optical Scanner will be marketed at first to drug researchers conducting gene analysis for pharmaceutical companies and university labs. But the partners plan eventually to pitch the high-speed scanner for other drug research uses, such as genotyping and cell analysis. Eventually, Matsushita and QDC hope to sell the scanner as a medical diagnostic device.
According to the developers the Mosaic scanner is a major breakthrough in scanner technology, reading the results of gene experiments up to 200 times faster than current PCR scanning techniques. This means pharmaceutical companies will be able to screen candidate drugs based on human genome research much more quickly and less expensively.