| ARUP Labs Becomes Vein-to-Vein Client ARUP Laboratories has signed a distribution contract for Wyndgate Technologies’ SafeTrace® donor-management system and SafeTrace Tx® advanced transfusion-management system. ARUP will use SafeTrace and SafeTrace Tx to manage its blood-donor center and centralized transfusion service. Terms of the contract were not disclosed. “We were in need of a software management system that could handle our current volume, as well as grow with us to meet projected needs to process more than 40,000 blood donations and more than 130,000 blood transfusion-related tests per year,” says Gloria Pitt, assistant vice president and IT manager for ARUP. “We were comfortable that SafeTrace and SafeTrace Tx could handle our needs both now and in the future. In addition, the centralized transfusion service functionality and proven HL7 interfaces in SafeTrace Tx, as well as the Vein-to-Vein® link to SafeTrace, were important features which helped drive our decision to move forward with Wyndgate Technologies.” Wm. Scott Dustin, vice president of sales and marketing for Wyndgate, says, “Robust functionality, interfaces to information systems, as well as analyzers and stable software functions are critical for large and complex organizations such as ARUP Laboratories. Our SafeTrace and SafeTrace Tx products are recognized leaders in these areas. We are proud to add ARUP Laboratories to our growing customer base.” Contact: ARUP Laboratories (800) 242-2787; www.aruplab.com |
 HCA Awards 7-Year Sole-Source Blood-Glucose Contract to RocheRoche Diagnostics has signed a new 7-year contract with HCA Inc to provide bedside blood-glucose-testing systems to all of the 180 HCA acute-care hospitals in the United States. The agreement is expected to have an overall value in excess of $50 million. The contract includes the ACCU-CHEK® Inform hospital blood-glucose meters, the ACCU-CHEK Comfort Curve® hospital test strips, the ACCU-CHEK Safe-T-Pro® lancet device, and ancillary information technology products. “This agreement is representative of a strong, long-standing relationship with HCA and HealthTrust Purchasing Group, and brings our full portfolio of hospital blood-glucose products to their customers,” says Rod Cotton, senior vice president of US point-of-care diagnostics for Roche. “It underscores our commitment to provide health care professionals with best-in-class products and innovative patient-management tools that deliver proven value and better patient care.” Contact: Roche Diagnostics (800) 428-5030; www.roche-diagnostics.com |
Spectrum Offers Roche Amplichip CYP450 Test
Spectrum Laboratory Network has announced it will offer the Roche Diagnostic AmpliChip CYP450 Test. The test is the first of its kind to be cleared by the US Food and Drug Administration (FDA) for the diagnostic analysis of two key drug-metabolism genes.
“Physicians can use the genetic information from this test to prevent harmful drug interactions and to assure drugs are used optimally, which in some cases will enable patients to avoid less effective or potentially harmful treatment choices,” according to an FDA press release.
“We are very pleased to be a leader in offering this valuable technology to our physicians and their patients,” says Karen Yoemans, Spectrum’s vice president of sales and marketing. “We view this as a giant step in the area of predictive modeling for effective therapy.”
Contact: Spectrum Laboratory Network (336) 664-6100; www.spectrumlab.org
Test for Evaluating Male Infertility Under Development
Repromedix has signed an exclusive licensing agreement with Whitehead Institute for Biomedical Research to develop the next generation of the
Y-Chromosome Microdeletion (YCMD) test for evaluating male infertility.
The original YCMD tests were developed by David Page, MD, and other researchers beginning in 1995 and led to the publication of the deleted in azoospermia (DAZ) gene. The new test by Repromedix will be able to detect several newly discovered deletions in the male Y chromosome, as well as offer improved localization of sites to better identify previously known deletions. Whitehead Institute has filed for patent protection of the new technology.
The new version of the YCMD test, when combined in a genetic male factor panel with the SDD™ and SDFA™ tests for assessing the level of DNA damage to a patient’s sperm, will provide a highly comprehensive and advanced evaluation of male fertility.
Page’s group pioneered the study of Y-chromosome deletions in infertile men and published the Y-chromosome DNA sequence. “We have made significant progress in refining and enhancing the YCMD tests,” he says. “We have done additional work on understanding the sequence and the mechanisms that generate specific structural deletions and other defects in the Y chromosome that affect male fertility that were not previously identified.”
Whitehead Institute has licensed the technology to Repromedix for both reference-lab testing and product-development applications.
Benjamin Rivnay, PhD, vice president of R&D for Repromedix, says his firm’s test would provide infertility specialists with more diagnostic information about the status of the male patient’s Y-chromosome abnormality. “The new YCMD test will also have a greater prognostic value with regard to infertility or subfertility because some deletions have been associated with complete failure to find sperm even in testicular biopsies,” he says. “The new test offers the potential to save patients both the emotional and financial costs of an unnecessary medical procedure. This test is a natural complement to other advanced male-fertility tests already provided by Repromedix.”
Robert D. Oates, MD, professor of urology at Boston University School of Medicine, was a participant in the clinical study. “Before any operative intervention or use of sperm for ICSI, a Y-chromosome microdeletion assay and karyotype should be performed in any male with severe oligospermia or nonobstructive azoospermia,” he says. “This new testing promises to provide urologists who specialize in male reproductive medicine and surgery with more complete data about the genetic basis for their patients’ reproductive failure, enabling the patient to make a more informed decision about whether or not assisted reproductive technology (ART) is appropriate for him and his partner.”
Howard Hughes Medical Institute investigator David Page, MD, and Steve Rozen, MD, and Helen Skaletsky, MD, of Whitehead Institute, developed the technology.
Contact: Repromedix (800) 667-8893; www.repromedix.com
| JCAHO Forms Health IT Advisory Panel The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has launched a Healthcare Information Technology Advisory Panel to help improve patient safety and clinical processes during the implementation of new health information systems. The panel will recommend ways the accreditation process and technology could be used to improve health care safety, quality, and efficiency. Additionally, the group will look at issues including the overall impact of electronic health records on performance benchmarking and public-reporting capabilities. The panel includes members from the Office of the National Coordinator for Health IT, the American Health Information Management Association, the Agency for Healthcare Research and Quality, the Veterans Health Administration, and the Healthcare Information and Management Systems Society. The panel also consists of researchers, physicians, nurses, CIOs, educators, and health care-organization leaders. Contact: JCAHO (630) 792-5000; www.jcaho.org |
Free Trial Allows Lab Techs to Test Pump
Lab technicians have been invited by Flexicon America Inc to try out its PF6 peristaltic dispensing pumps. The company believes this will allow users to experience consistent accuracy, ease of use, and validation simplification for a broad array of sterile dispensing needs.
The PF6 is a flexible liquid dispenser that can fill volumes from 0.5 mL to more than 250 mL with accuracy better than +/- 0.5%. The peristaltic pump uses medically approved sterile silicone tubing and a stainless-steel filling needle, the only parts of the pump that come in direct contact with the liquid.
Replacement of the tubing and needle is all that is required for product changeover. The PF6 pump accommodates tubing with diameters from 0.5 mm to 8.0 mm to provide flexibility for handling a wide range of fill volumes.
Contact: Flexicon America Inc (802) 657-3232; www.flexiconamerica.com
 COLA Partners with AAFPThe Commission on Office Laboratory Accreditation (COLA) and the American Academy of Family Physicians (AAFP) have formed “AAFP Lab Partners,” a partnership to service AAFP members and COLA labs. The new pairing will reduce costs for AAFP’s 120,000 members and COLA’s labs through discounts on lab accreditation programs, symposiums, e-learning courses, laboratory-director programs, and proficiency-testing programs. COLA will offer AAFP members its laboratory-accreditation program at a discounted rate and offer new AAFP members its e-learning courses free of charge. AAFP members will also receive a discount on additional COLA Lab University e-learning courses. All COLA laboratory accreditation and education activities are now approved by AAFP for its members. “The collaboration between COLA and AAFP will provide AAFP members and COLA participants with many cost-saving benefits neither previously had access to,” says Doug Beigel, CEO of COLA. “We look forward to the partnership and the expanding opportunities that may lie ahead.” COLA will ensure that its Laboratory Director Program meets and maintains Clinical Laboratories Improvement Act training requirements for moderate-complexity laboratory physician-directors. The new agreement also benefits COLA participants who are interested in AAFP’s proficiency-testing program. COLA labs will be offered the AAFP-PT program at a discounted price through the partnership. Contact: COLA (800) 981-9883; www.cola.org |
| New Oxycodone Assay Can Be Used On Olympus Analyzers Olympus has developed applications for the new DRI® Oxycodone assay on its chemistry-immuno analyzers, in conjunction with the assay’s recent introduction by Microgenics Corp. The assay has applications for the Olympus AU® chemistry-immuno analyzer system platform, including the AU400/400e, AU600, AU640/640e, AU2700, and AU5400 chemistry-immuno analyzers. The Oxycodone assay is NAD-G6PDH-based and can be read bichromatically at 340/410 nm. Results can be determined as qualitative (pass/fail) at cutoffs of 100 ng/mL or 300 ng/mL. They can also be determined semiquantitatively up to 1,000 ng/mL. The DRI Oxycodone assay is used to measure oxycodone in urine. Oxycodone is a potent pain medication and a nervous-system depressant sold under the trade names OxyContin®, Percodan®, and Percocet®, among others. Contact: Olympus Diagnostic Systems Group (800) 223-0125; www.olympusamerica.com |
UCSD Plans New Nanotechnology Center
The National Cancer Institute (NCI) has awarded the University of California, San Diego (UCSD) a multimillion-dollar grant to establish a Center for Cancer Nanotechnology Excellence (CCNE) as part of a new national effort to fight cancer with “nanoscale” devices that find and destroy tumor cells while leaving healthy cells unharmed.
Sadik Esener, principal investigator of the Center for Cancer Nanotechnology at UCSD.
The agreement began with an initial first-year donation of $3.9 million; the initiative is for 5 years with a total sum of $20 million. At the UCSD center, nanotechnology will be used to develop anti-cancer therapies that directly target tumor cells, more accurate and faster diagnostics, and ways to track down cancer cells that survive therapy.
The NCI named a total of seven university centers to develop clinically useful nanotechnology platforms to treat, understand, and monitor cancer. The UCSD team includes engineers, chemists, and biologists who will collaborate with physicians at the Rebecca and John Moores UCSD Cancer Center and colleagues at the Burnham Institute for Medical Research, as well as at UC campuses at Irvine, Riverside, and Santa Barbara, to develop nanotechnology devices so small they are measured on a molecular scale.
“This Center for Excellence will bring the best minds in engineering, basic and translational research, and clinical care together to apply the power of nanotechnology to the improved treatment of cancer,” says UCSD Chancellor Marye Anne Fox. “Such an effort represents the tremendous value of collaboration, not only across disciplines, but also among institutions, resulting in important innovations that benefit our society.”
UCSD’s team will focus on “mother ships,” or smart nanoplatforms capable of homing in on tumors and delivering payloads of smaller particles to perform various tests in the tumors. The micron-sized nanoporous mother ships, about the size of a red blood cell, will move through the body and target specific tumor cells or the blood vessels that feed them. Upon arriving at their destinations, the mother ships will release their payload nanoparticles, which could be designed to help image tumors, enter cells, perform measurements, and deliver therapies. Chemists at UCSD, with materials scientists from University of California at Santa Barbara’s nanofabrication facility, will synthesize nanoparticles that will be coated with “biolinkers”—molecules developed at the Burnham Institute to make the particles attach to specific types of tumor cells.
“Nanotechnology allows us to much more specifically and accurately deliver an array of promising new treatments to the exact positions in the body where they are needed,” says Sadik Esener, professor of electrical and computer engineering at the UCSD Jacobs School of Engineering and the principal investigator at the UCSD center. “Nanotechnology will also enable doctors to get more rapid noninvasive feedback on the effectiveness of treatment. When biopsies are needed, these approaches will require much smaller tissue samples for analysis in the laboratory.”
The UCSD Center for Excellence will focus on noninvasive treatments for leukemia and breast cancer to take advantage of the expertise in studying those diseases by scientists at the Moores UCSD Cancer Center. “Cancer nanotechnology is one of the most exciting and promising areas of cancer research today,” says Dennis Carson, MD, director of the Moores UCSD Cancer Center. “This science of the very small may translate to very big changes for cancer patients. We are developing powerful drugs and other chemotherapeutic agents that are more and more effective when they reach their target. But we need engineers and materials scientists to build the nanodevices that can deliver these agents to the target. At the cancer center, we are embracing nanotechnology as part of our focus on translating scientific advances into new options for patients.”
Additionally, the center plans to focus on six projects, each developing new technologies that will create platforms for more powerful and selective cancer therapy, when integrated with one another. The technologies will be evaluated in animal models. To help identify inventions with commercial potential, representatives from General Electric, Honeywell, Irvine Sensors Corporation, Nanogen, and Enterprise Partners Venture Capital will serve on a committee to regularly evaluate the progress of UCSD’s research.
Contact: Rebecca and John Moores UCSD Cancer Center (858) 534-7600; cancer.ucsd.edu
Nikon Appoints Bacus Labs as Reseller of Coolscope VS
Nikon Instruments Inc has announced that Bacus Labs Inc will become an authorized reseller of Nikon’s COOLSCOPE VS. Bacus Labs gains rights to distribute a new turnkey software solution that allows pathologists to conduct analysis and share results over global public or private networks at any given point during the day, anywhere.
“Our goal is to continue to grow functionality to transform the software suite into the world’s leading platform for sophisticated pathology analysis for use by pathologists, clinical specialists, and university instructors,” says James Bacus, MD, president of Bacus Labs.
The Nikon COOLSCOPE VS pathology software suite is a virtual slide pathology-analysis solution that can be used locally to capture and analyze high-resolution specimen images. The COOLSCOPE VS can be used for remote pathology consultation with its unique Internet-enabled technology.
The software suite for the COOLSCOPE VS consists of the following applications: DNA Ploidy, where pathologists can measure the DNA content of individual cell nuclei and create a DNA histogram that estimates the population distribution for the specimen under observation; Nuclear Grade, where morphometric measurements from ILM nuclear images can generate a continuous grade related to cancer development; and Cell View, where pathologists can view the ILM nuclear image files extracted by the DNA Ploidy program and enable various morphometric parameters to be viewed in the context of each nucleus.
Contact: Nikon Instruments Inc (800) 52-NIKON; www.nikon-instruments.com
| TREK’s Tigecycline Gets FDA Clearance TREK Diagnostic Systems Inc has received 510(k) clearance from the US Food and Drug Administration (FDA) for Tigecycline for Sensitre® MIC-susceptibility plates, making the company the first susceptibility test manufacturer of dry microbroth dilution plates to offer an in vitro diagnostic-use label to test Tigecycline in diagnostic laboratories. TREK received clearance to test and report Tigecycline against aerobic facultative Gram-positive and aerobic facultative Gram-negative bacterial groups using Sensititre MIC-susceptibility methods. Tigecycline is the first glycylcycline and was designed to circumvent key bacterial-resistant mechanisms. It is currently available for inclusion on custom plates, or can be tested on JustOne® for Tigecycline. Gram-negative and gram-positive MIC plates will contain Tigecycline later this year. “We are proud to announce the availability of Tigecycline on Sensitre plates for in vitro diagnostic-susceptibility methods,” says Jenny Lorbach, global product manager for Sensitre. “The immediate availability of Tigecycline for Sensitre MIC test procedures emphasizes our success with early FDA clearance on new compounds versus other test systems.” Contact: TREK Diagnostic Systems Inc (216) 351-TREK; www.trekds.com |
GE Healthcare to Acquire IDX Systems
GE Healthcare will acquire IDX Systems Corporation in a definitive merger agreement. The companies plan to create a leading health care information technology vendor and a comprehensive suite of clinical, imaging, and administrative information systems. Following the transaction, IDX shareholders will receive $44 per share payable in cash in the merger, for a total consideration of approximately $1.2 billion, net of IDX cash and equivalents.
“GE and IDX have a shared vision on how to accelerate the adoption of electronic health records across the globe,” says Joe Hogan, president and CEO of GE Healthcare. “We are extremely excited about joining with IDX and believe that our combined offerings are in line with where health care is headed and match the needs of our customers.”
“IDX has grown substantially in recent years, and we believe our opportunities for continued growth and expansion will be best realized through the additional scale and resources that a company like GE can provide,” says Jim Crook, CEO of IDX. “As part of GE Healthcare, we believe we will be able to capitalize more fully on the rapidly expanding opportunities in the health care IT industry worldwide to fulfill our mission to make a difference in health care.”
The transaction, subject to IDX shareholders, regulatory approvals, and other customary conditions, is expected to close by early 2006. In connection with the transaction, certain shareholders representing approximately 20% of the IDX shares outstanding have agreed, among other things, to vote their shares in favor of the proposed transaction. The boards of directors of GE and IDX have approved the transaction.
Contact: GE Healthcare (877) 438-4788; www.gehealthcare.com
Flu A+B Test That Detects Avian Influenza Receives 510(k) Clearance
The US Food and Drug Administration (FDA) has granted 510(k) clearance for BD Diagnostics’ Directigen™ EZ Flu A+B Test. The two-step, rapid influenza test differentiates between influenza A and influenza B in 15 minutes or less. Confirmed differential diagnosis helps guide health care providers in the selection of appropriate treatment, such as administration of antivirals to certain patient populations. Analytical studies have shown the test capable of detecting avian influenza H5N1 isolates.
The BD Directigen EZ Flu A+B test features two distinct windows on a single device to discriminate between the two strands of influenza. The test offers convenient room-temperature storage. Commonly used oral medications, including throat drops, nasal sprays, and ibuprofen, have shown no interference with test results in analytical evaluations. It is compatible with multiple transport media and has been validated for use with multiple specimen types, saving laboratories time and resources.
“Rapid diagnostics are extremely important in that they allow health care providers to rule out other respiratory infections, confirm a case of influenza, and select the appropriate treatment in a timely manner,” says Michael Towns, MD, vice president of World Wide Medical Affairs at BD Diagnostics—Diagnostic Systems. “These capabilities are particularly relevant when one considers that the window of opportunity to effectively implement antiviral therapy is only 48 hours from the onset of symptoms. Antivirals can reduce the severity of symptoms, shorten the duration of the illness, and reduce the time period when patients who are ill with influenza are infectious to others.”
A strain of avian flu has caused the death or destruction of tens of millions of birds in eastern and central Asia. Additionally, a total of 59 deaths and 115 confirmed cases in humans have been reported to the World Health Organization (WHO) since January 2004. To date, humans have only contracted bird flu after coming into contact with infected animals. Scientists are worried the disease may mutate into a highly infectious pandemic flu that is transmissible from human to human, with a high rate of morbidity and mortality worldwide.
“In the event of a human flu pandemic, diagnostic tests will be absolutely necessary to ensure proper allocation of limited supplies of antiviral therapies to those at high risk of complications from the flu,” says Elliot Rank, PhD, director of scientific affairs at BD Diagnostics—Diagnostic Systems. “Use of these [tests] can also help achieve the high levels of laboratory efficiency that would be critical in the event of the high patient influx and emergency patient care that would occur with an influenza pandemic.”
Contact: BD Diagnostics (800) 638-8663; www.bd.com
 Two Companies Join to Develop Visual Diagnostic SoftwareThomson Micromedex and Logical Images have entered a partnership to provide hospitals and other health care organizations with VisualDx®, a point-of-care clinical decision support software system for visual diagnosis. VisualDx minimizes the potential for medical error in conditions with visual signs and symptoms. The application is used at the point of care for accurate diagnosis to yield faster, better treatment decisions and improved clinical outcomes. “VisualDx helps clinicians in hospitals, emergency rooms, government agencies, and other organizations make better decisions, ultimately reducing costs and improving outcomes and safety—including potential bioterrorist acts,” says Jay Katzen, vice president of marketing and product development of Thomson Micromedex. Many primary care and emergency physicians lack training in visual diagnosis, dermatology, and infectious disease. It is, in most cases, necessary for clinicians to know the name of the diagnosis to access photographs, symptomology, and treatment information using textbooks and Web-based atlases. With VisualDx, clinicians simply enter a patient’s symptoms and compare what they see with the system’s images and data on each disease similar to that found in reference books and other information guides. Additionally, VisualDx is a tool for early detection and treatment of conditions caused by chemical, biological, and radiological substances. The application is a front-line diagnostic solution that enables institutions to meet bioterrorism-preparedness mandates for early detection and treatment as set by the US Department of Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention (CDC). Contact: Thomson Micromedex (303) 486-6400; www.micromedex.com |
DTSC Recertifies Scigen Technology
California’s Department of Toxic Substance Control recently approved the re-certification of Scigen Ltd’s Neutralex® technology for the safe treatment and disposal of spent formalin waste from histopathology specimen-preservation and tissue processors.
Certification is in effect until the year 2008. The recertification process involved testing by lab and hospital users who found Neutralex to be an effective treatment for their spent formalin. Neutralex, when mixed with spent formalin, achieves aldehyde neutralization with no pH adjustment in a 15-minute time frame, allowing users to safely dispose waste down the drain. Additionally, Neutralex contains no drain-clogging polymer by-products. Failure to properly dispose of formalin under current law could result in a fine of $25,000 per occurrence.
“We are proud that the state has continued to recognize our technology in this important area of waste disposal,” says Steve Wheeler, CEO of Scigen.
Scigen’s Neutralex is a cost-efficient solution when compared to waste hauling and the liabilities associated with this process. Current law holds hospitals and laboratories responsible from a liability standpoint, not in just the delivery to the waste hauler but also to the destination point. Discussion among lawmakers is under way to make those entities that create the waste responsible for any leaking delivery. “The liability as well as the potential liability for hospitals and laboratories is ever increasing with regard to waste disposal,” says Wheeler. “Scigen offers these institutions a solution to reduce their risk, cost, and liability.”
Contact: Scigen Ltd (952) 939-0882; www.scigenltd.com
New Blood-Bank System for ABO/Rh Testing, Antibody Screening
Olympus America Inc has introduced the TANGO® Automated Blood Bank System. Designed for hospital transfusion services, donor centers, and reference laboratories, TANGO is capable of performing a host of functions, including blood group determination; antibody screening and identification; phenotyping; and compatibility testing.
TANGO, with a throughput of approximately 200 wells per hour depending on test configuration, provides hospital transfusion-service laboratorians a more efficient tool in areas where space is tight and functionality is key. The benchtop analyzer measures 4.2 x 2.2 x 2.4 feet and weighs 286 pounds. It performs pipetting sequences of liquids and subsequent analysis of agglutination reactions.
The fully automated process includes positive sample identification; process control through automated recording of reagents (lot numbers, expiration dates); sample dilutions; reagent addition and mixing; incubation; washing; centrifugation; and image analysis.
For greater flexibility, TANGO systems feature batch and random-access operating modes and STAT sample interrupt. For easy use and maximum efficiency, it employs the Windows® NT operating system, a Pentium® processor, a touch-screen interface, and image-analysis software.
Olympus debuted the software at the American Association of Blood Banks (AABB) national meeting during October in Seattle.
Contact: Olympus Diagnostic Systems Group (800) 223-0125; www.olympusamerica.com
| MedAssets to Distribute Sigma-Aldrich Products Sigma-Aldrich has inked an agreement with MedAssets Supply Chain Systems for the supply group to distribute Sigma-Aldrich’s Med Basics products. The MedBasics product line, established in 2004, consists of more than 3,000 products used frequently by medical testing laboratories as routine reagents. The products include buffers, cell-culture reagents, histology stains, immunology reagents, laboratory equipment, molecular biology reagents, and solvents. “Sigma is extremely pleased to be able to meet both the specialty and routine chemistry and bioscience needs of MedAssets’ members,” says George Crowell, Sigma-Aldrich market segment manager. “This is an excellent opportunity for Sigma to demonstrate its world-class quality service and products to these customers.” Contact: Sigma-Aldrich (800) 336-9719; www.sigmaaldrich.com |
Nanogen To Release Congestive Heart Failure Test
StatusFirst™, Nanogen’s point-of-care congestive heart failure test, is currently under development. The new assay tests N-terminal atrial natriuretic peptide (NT-proBNP) cardiac biomarker from the natriuretic peptides. StatusFirst is unique in that it uses NT-proBNP, while others currently only measure BNP.
A study published in the European Journal of Heart Failure concluded that patients with severe congestive heart failure who have elevated levels of NT-proBNP have a higher risk of 1-year mortality. The study gauged N-terminal atrial natriuretic peptide (NT-proAnP), BNP, and NT-proBNP and found all to be significant individual predictors of 1-year mortality. Additionally, the study showed that the risk of mortality from congestive heart failure could be more accurately ascertained if levels of NT-proBNP are known, even after accounting for other important clinical variables, such as the severity of heart failure.
“By developing a point-of-care diagnostic utilizing this marker, Nanogen takes another step forward in its mission to bring diagnostic tools that improve accessibility and quality of information available to health care providers so that they can select the appropriate course of therapy and potentially extend the lives of patients,” says Howard C. Birndorf, Nanogen’s chairman of the board and CEO.
Contact: Nanogen (877) NANOGEN; www.nanogen.com
RTI Awarded Contract to Help Develop National Health Information Network
Research Triangle Institute (RTI) International has been awarded an $11.5 million contract from the Agency for Healthcare Research and Quality (AHRQ) to support efforts to develop a national health information network (NHIN), a system in which electronic health records would be stored and shared among health care providers nationwide.
Establishing the network represents a critical shift in the nation’s health care system aimed at increasing the “portability” of health care and the accuracy of medical diagnoses, treatments, and prescriptions, while also reducing health care costs.
The challenge in establishing the network is to develop technology and business-process standards that allow nationwide access and interoperability while keeping patient information secure, protecting individual patient privacy, and ensuring the appropriate degree of patient control over their records.
“Technical feasibility is just the beginning of achieving interoperable health records and realizing the potential of health IT,” says Carolyn M. Clancy, MD, AHRQ director. “We must also ensure the privacy and security of health records and, at the same time, address the many differing privacy and security requirements that exist state to state and business to business. The starting point is today’s contract, which will survey the varying requirements in state laws and business practices. Then, we will need to work together to build a coherent system enabling safe, secure, and legal transfer of records throughout the nation.”
Under the terms of the 18-month contract, RTI will form the Health Information Security and Privacy Collaboration (HISPC), a new partnership consisting of a multidisciplinary team of experts and the National Governors Association. This team will work with approximately 40 states or territorial governments to assess and develop plans to address variations in organization-level business policies and state laws that affect privacy and security practices that may pose challenges to interoperable health information exchange.
Regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) established baseline health care privacy requirements for protected health information and established security requirements for electronic protected health information. Many states have adopted policies that go beyond HIPAA. The manner in which hospitals, physicians, and other health care organizations implement required security and privacy policies varies and is tailored to meet their individual organizations’ needs. These variations in policies present challenges for widespread electronic health information exchange.
“We are very pleased to support this important initiative by the Agency for Healthcare Research and Quality to improve the delivery of health care for all Americans,” says Chuck Thompson, vice president of RTI’s Federal Healthcare Optimization and Strategic Solutions. “We look forward to working closely with AHRQ, representatives of state governments, the National Governors Association, and the many other stakeholders involved in this national effort.”
To support this project, RTI has assembled a team of leading experts from fields ranging from privacy and security law and health care management to information technology and business process analysis.
“The complexity of this project requires extensive collaboration among a diverse team of experts who will support the work at the state and regional level,” says Linda Dimitropoulos, a senior survey director at RTI who will coordinate efforts within each state to assess the needs, concerns, and regulations governing state health care programs. “We are excited about the opportunity to work alongside the leading professionals in their fields who are our partners in this project.”
Project team members will work closely with the AHRQ project officer, Scott Young, MD; the national coordinator of health information technology, David Brailer, MD; and up to 40 state governments to identify best practices and to develop solutions to laws and business practices that impede health-information exchange.
The contract is one of four key components of the US Department of Health and Human Services (HHS) information technology plan, which calls for coordination between four major concurrent projects. The other components include the following:
• A project to harmonize the health care and technology standards used in health information interchange (ONCHIT-1), to address gaps and conflicts in current standards;
• A project to evaluate functionality and interoperability of the many and various electronic health care record products and technologies currently available on the market (ONCHIT-2), the complexity of which currently makes adoption of any single product risky for many physicians, especially for small and rural providers; and
• A project to develop and evaluate prototypes for the network architecture (ONCHIT-3) to assess the feasibility of developing an NHIN prototype. HHS will develop and refine the business case for establishing the network, which will use work resulting from each of these projects. “These contracts are a significant milestone in a broader strategy to spur technical innovation for nationwide sharing of health information and adoption of electronic health records,” Brailer says. “This work will set the stage for an Internet-based architecture that will allow secure, timely, and accurate exchange of health information among patients, clinicians, and other authorized health care entities.”
Contact: RTI International (919) 485-2666; www.rti.org
| Delaware Hospitals Prepare For Disasters with Diagnosis Software Delaware’s Division of Public Health has chosen the VisualDx® software by Logical Images to be installed in hospitals nationwide. The system is being funded through grants from the National Bioterrorism Hospital Preparedness Program administered by the federal Health Resources & Services Administration (HRSA). “We’re pleased that Delaware chose VisualDx as a way to increase bioterrorism preparedness,” says Micheal O’Connor, president of Logical Images. VisualDx will be installed in every acute-care hospital emergency department in the state, he says. The VisualDx software system allows clinicans to input specific information based on their examination of a patient. The system then searches its database of more than 10,000 images of 600 diseases and comes up with high-quality photos and descriptions of possible conditions that fit the information the doctor has input, enabling a rapid and more accurate diagnosis and prompt treatment. Due to its detailed information on anthrax, smallpox, and other agents that might be intentionally released by terrorists, bioterrorism-preparedness experts say VisualDx is a valuable tool in the war on terrorism. “Visual Dx was designed as a dual-purpose system so that in addition to its terrorism-related capabilities, it is used on a daily basis in hospitals, clinics, and public-health settings to quickly and accurately identify visually diagnosable conditions such as infectious diseases, sexually transmitted diseases, skin conditions, oral lesions, drug eruptions, and the like,” says Art Papier, MD, Logical Images’ chief scientific officer. “Particularly in areas with limited access to dermatologists or infectious-disease specialists, VisualDx helps emergency physicians and primary care doctors by giving them visual as well as textual information so they can make an accurate diagnosis and start the right treatment quickly.” The dual-purpose nature of VisualDx is important to emergency-preparedness officials in Delaware. “Using Visual Dx on a day-to-day basis to diagnose rashes and the like means there isn’t going to be a learning curve in an emergency,” says Gerald Watson, safety manager for Alfred I duPont Hospital in Wilmington and a member of the Delaware State Emergency Preparedness Committee. Additionally, VisualDx is now being used by the US Army; major hospitals and public health clinics throughout New York City, Washington, DC, and the state of Mississippi; regional resource centers throughout New York State; and many other emergency departments, hospitals, physician offices, and clinics in the United States and worldwide. Contact: Logical Images (800) 357-7611; www.logicalimages.com |
| Hybrid Mass Spectrometer Receives Award Shimadzu Scientific Instruments Inc’s newest mass spectrometer has received an R&D Magazine OE2005 R&D 100 award. The new hybrid Ion Trap-Time-of-Flight instrument was selected as a breakthrough technology and achieved the award in the Analytical Instruments category. Shimadzu’s LCMS-IT-TOF is designed for a wide range of uses, including biomarker studies, metabolomics, proteomics, metabolite identification, environmental analyses, forensics uses, and homeland-security functions.  The LCMS-IT-TOF instrument, developed by a research team of scientists and engineers at Shimadzu Corp, enables researchers to perform multiple levels of ion fragmentation with high mass accuracy. Specifically, the LCMS-IT-TOF was designed to deal with the stringent requirements of identification of pharmaceutical impurities, natural products, and metabolites.
Obtaining exact mass measurements with high sensitivity and multiple levels of fragmentation is critical for taking the guesswork out of compound identification and speeding up analytical processes. “This is the first ion trap-time-of-flight instrument for HPLC use that’s widely available to researchers,” notes Shigehiko Hattori, president and CEO of Shimadzu Corp. “We worked very hard to combine the best benefits of ion traps and time-of-flight mass spectrometers, and to have our rigorous research and development garner such a prestigious award is a real signal that our efforts were successful.” The Shimadzu LCMS-IT-TOF maintains its high sensitivity by improving control over the entire ion collection and ion-transfer process. Major innovations in the design include improvements to collect more ions, compress ions more rapidly into the trap with high efficiency, and efficiently transfer ions to the TOF (time-of-flight) portion of the instrument. Coupling atmospheric pressure ionization with its IT (ion trap) and TOF technologies, the LCMS-IT-TOF delivers both high mass accuracy, and high mass resolution (>10,000 at 1,000 m/z). It is designed to maximize sensitivity and selectivity, and redefines the capabilities of the quadruple ion trap, which not only supports high precursor ion selection and fragmentation of ions before ejection into the TOF, but also allows ballistic on ejection into the TOF to minimize energy spread of ions exiting the trap. Contact: Shimadzu Scientific Instruments Inc (610) 269-2100; www.ssi.shimadzu.com |
ESA System Chosen for Lead-Screening Program in Connecticut
The Public Health Foundation of Connecticut Inc has selected ESA Biosciences’ LeadCare® Blood Lead Testing System to help implement a lead-poisoning screening and prevention program for children. The ESA system will be used to increase the screening of children in preidentified high-lead-exposure/medically underserved neighborhoods of Danbury, Hartford, and Meriden for lead poisoning. The program, titled “A Healthy Neighborhood Is A Lead Safe Neighborhood,” will focus on primary prevention and screening, community education and outreach, case management, follow-up hazard remediation, and public-health surveillance.
“Exposure to lead is associated with a range of serious health effects on children, including cognitive and behavioral developmental problems that can result in serious, long-term consequences,” says Michael J. Purcaro, executive director of the foundation.
“In Connecticut, it is estimated that more than 1,000 children under the age of 6 go undiagnosed with lead exposure per year,” Purcaro continues. “The Foundation wants to change that situation with the help of the LeadCare system. The ESA system is portable and easy to use, enabling health care providers to actively go out into their communities to test the children where they live. This is especially valuable to the children and families who live in neighborhoods with elevated lead-exposure risks with barriers to accessing the health care system.”
Three LeadCare instruments are being provided by ESA Biosciences through the Foundation for deployment to local clinics in Danbury, Hartford, and Meriden. “We are pleased to provide the use of these analyzers to such a worthy project and look forward to seeing more children at risk for lead poisoning receive a lead test,” says Bruce Weiner, director of blood lead products for ESA Biosciences.
The ESA LeadCare System is a far less invasive procedure than the traditional venipuncture method, and therefore it is less traumatic for the child because it significantly decreases the amount of blood needed for testing. Besides removing this major hurdle for getting a child tested, the LeadCare system provides results in just 3 minutes, enabling families to know immediately if further care is necessary so they can follow up with a physician right away. ESA’s LeadCare System was developed with a grant from the Centers for Disease Control and Prevention and is used by pediatricians, family physicians, public health departments, hospitals, and military laboratories around the world.
Contact: Public Health Foundation of Connecticut Inc (860) 224-2200; www.cthealth.org or ESA Biosciences Inc (800) 959-5095; www.esainic.com
Update on Regulatory Applications for Investigational Blood-Screening Products
Gen-Probe Inc has updated the status of its investigational blood-screening products, based on recent communications with the US Food and Drug Administration (FDA).
The FDA notified Gen-Probe at the close of business on October 3 that it considers the PROCLEIX® TIGRIS® system “not substantially equivalent” to the PROCLEIX enhanced semiautomated system (eSAS) for screening donated human blood with the PROCLEIX ULTRIOTM assay. The FDA made this determination in response to Gen-Probe’s 510(k) application for the TIGRIS system. Gen-Probe has discussed the determination with the FDA and is scheduling a series of meetings to resolve the outstanding issues.
Gen-Probe previously received 510(k) marketing clearance for the eSAS system used to screen donated human blood using the ULTRIO assay. Gen-Probe also expects approval of its Biologics License Application (BLA) for the ULTRIO assay this year. This approval, if granted, would enable customers in the United States to run the ULTRIO assay on the eSAS system on a commercial basis.
“While we are disappointed that marketing clearance for the ULTRIO assay on the TIGRIS system is unlikely by year-end, we are encouraged that the eSAS 510(k) has been cleared, and that the BLA for the ULTRIO assay remains on track,” says Hank Nordhoff, Gen-Probe’s chairman, president and CEO. “The combination of these two approvals would enable US blood-screening customers to begin testing with the ULTRIO assay on our semiautomated instrument system. Gen-Probe estimates that at least half of initial US customers who would adopt the ULTRIO assay in 2006 would begin testing on the eSAS system. In addition, we continue to believe that the revolutionary TIGRIS system will be an important advance for US blood-screening customers, as it is proving to be around the world.”
The ULTRIO assay, TIGRIS system, and eSAS system are all approved for commercial blood-screening use in many countries outside the United States. Most current ULTRIO customers worldwide conduct testing using the eSAS system.
Gen-Probe also confirmed that it expects approval of its BLA for the West Nile virus (WNV) assay on the eSAS system in early 2006. This year, the vast majority of investigational West Nile virus testing has been conducted on the eSAS system.
The ULTRIO assay was developed to simultaneously detect human immunodeficiency virus type 1 (HIV-1), hepatitis C virus, and hepatitis B virus in specimens from donated blood, plasma, organs, and tissue. Gen-Probe filed its BLA for the ULTRIO assay in September 2004.
The fully automated, high-throughput TIGRIS system can process 1,000 blood samples in about 14 hours, facilitating testing in smaller pool sizes and increasing assay sensitivity. Upon US regulatory clearance of the ULTRIO assay on the TIGRIS system, Gen-Probe would earn a $10 million milestone from Chiron. Chiron markets and distributes all PROCLEIX products worldwide.
In the clinical diagnostics arena, the TIGRIS system received 510(k) marketing clearance from the FDA in December 2003 for use with the APTIMA Combo 2 assay to detect Chlamydia trachomatis and Neisseria gonorrhoeae.
Contact: Gen-Probe Inc (800) 523-5001; www.gen-probe.com
