New Study Reports on ThinPrep’s Improved Disease Detection
Cytyc Corp has announced that a study published in the May–June issue of Acta Cytologica reports that implementation of the ThinPrep® imaging system significantly increased detection of cervical squamous intraepithelial lesions compared to manually screened ThinPrep Pap Tests. Acta Cytologica is the official periodical of the International Academy of Cytology.
The study, conducted at Mercy Medical Center (Springfield, Mass), compared more than 27,000 manually screened ThinPrep pap tests with a similar number of ThinPrep pap tests screened using the ThinPrep imaging system. The authors report a statistically significant increase in the detection of all cytologic categories in the ThinPrep imaging system group. This includes a 30.7% increase in the detection of low-grade squamous intraepithelial lesions, and a 20% increase in the detection of high-grade squamous intraepithelial lesions (HSIL). The study also confirmed through biopsy results that increased detection of HSIL in the imaging system group was true disease rather than false-positive cytologic diagnoses. The authors conclude, “In this study, the ThinPrep Imaging System proved superior to manual screening in the detection of cervical SIL.”
“The results of this study continue to demonstrate the clinical effectiveness of our state-of-the-art technology,” says Ellen Sheets, MD, Cytyc’s chief medical officer. “We believe the ThinPrep Imaging System provides laboratories, clinicians, and patients the best technology available for cervical cancer screening.”
Contact: Cytyc Corp (800) 442-9892; www.cytyc.com
Invitrogen Announces the Availability of Fluorescent Proteins
Invitrogen Corp has released advanced vectors for Vivid ColorsÔ Fluorescent Proteins, which represent the next generation of enhanced green fluorescent proteins (EGFP) for use in fluorescence microscopy or flow cytometry. Improving upon EGFP, Invitrogen’s Vivid ColorsÔ, derived from the Aequorea victoris jellyfish, are not prone to aggregation, are enhanced for extreme fluorescence, and are humanized for optimal mammalian expression. Benefits of Vivid ColorsÔ vectors and associated products include extended reporter-protein fluorescence—up to 24 hours—and multiple colors for covisualization applications.
Contact: Invitrogen Corp (760) 603-7200; www.invitrogen.com
Sysmex Receives FDA Clearance for Analyzer
Sysmex America Inc has announced that the Sysmex XS-1000i Í Automated Hematology Analyzer has been cleared by the US Food and Drug Administration (FDA) for use in clinical laboratories and physician’s offices. The new analyzer, available both with and without an auto sampler, uses fluorescent flow cytometry and advanced cell-counting methods to deliver rapid, reliable test results, which are essential in advanced patient diagnosis and therapeutic monitoring. This analyzer represents the completion of the Sysmex X-Series family of hematology instruments.
The Sysmex XS-1000i provides medical laboratory personnel with discrete hematology testing options for CBC and CBC with five-part differential, using fluorescent flow cytometry for WBC analysis and hydrodynamic sheath flow technology for the measurement of red cell and platelet cell counting. Sampling is done in a “closed-tube” environment, ensuring operator safety. The XS-1000i offers 21 testing parameters. As with all Sysmex analyzers, the system uses only nonhazardous reagent systems.
“With FDA’s clearance of the XS-1000i, Sysmex is truly in a unique position of being able to offer the same state-of-the-art technology platform to any size laboratory. Whether it is a small laboratory or a larger institution, we are the only vendor that can offer them access to the same powerful diagnostic capabilities,” says John Kershaw, president, Sysmex America Inc.
Contact: Sysmex America Inc (847) 996-4500; www.sysmex.com/usa
Biotest AG Receives Approval to Market Line of Transfusion Reagents in Canada
Biotest AG has been cleared by Health Canada to market a comprehensive line of transfusion diagnostic reagents for blood-compatibility testing. The Biotest reagents, available through RWR Scientific in Ottawa, ON, include Seraclone® typing and rare antisera reagents, antihuman globulin, and red-cell reagents for typing, antibody detection, and identification.
“We are pleased with the opportunity to expand our transfusion business in Canada with a full line of quality traditional transfusion reagents,” says Bill Weiss, president of Biotest USA.
In addition to the traditional transfusion reagents, Biotest’s fully automated instrument for transfusion diagnostics, Tango, was introduced last year in Canada and is currently marketed by Olympus Corp.
“The line of Biotest reagents creates another viable option for health care providers to choose from,” says Joy Thomson, manager of Transfusion Technical Services.
Contact: Biotest (800) 522-0090; www.biotestusa.com
Nanogen Announces Type 2 Diabetes Research Collaboration
Nanogen Inc, developer of advanced diagnostic products, has announced an agreement with Oy Jurilab Ltd, the Finnish genomics company. The collaboration is designed to identify and validate new prognostic markers for type 2 diabetes, one of the leading causes of death in the United States.
“There are 20 million children and adults living with diabetes in the US, and many of them are undiagnosed until they develop complications,” says Howard C. Birndorf, Nanogen chairman and CEO. “Combining genetic data about risk with early intervention strategies can have a significant impact on reducing disease incidence and severity, and we expect to see extensive demand for prognostic and diagnostic tests, as well as for new effective drugs.”
Complications arising from diabetes include heart disease, stroke, blindness, kidney disease, and nervous-system damage, constituting a tremendous economic burden on health care systems. The global incidence of diabetes has been on the rise, in both developed and developing countries, and is projected to reach 220 million by 2010.
Jurilab has access to genetic screening of an isolated population in East Finland, which is derived from one of the most genetically homogeneous populations available. Estimated at approximately 20 generations old, it is about half the age of other populations employed in screening programs. Fewer generations result in less genetic variation, and statistically significant data can be derived from relatively small sample groups, reducing research time and costs.
Through the current agreement, Nanogen will gain access to markers identified by Jurilab in genomewide screens. Certain markers seem to be associated with predisposition to diabetes; others appear to protect against developing the disease. Both Jurilab and Nanogen plan to validate the diabetes associations of these markers in populations outside Finland, including case controls in Catalonia, England, and Germany, and from Ashkenazi Jews. Subsequent to validation, Nanogen intends to develop diagnostic tests for panels of confirmed markers, and the companies will jointly seek licensing opportunities with pharmaceutical companies to develop therapeutics based on genes determined to play a causative role in the disease.
“The collaboration with Jurilab offers an opportunity for us to expand our presence in the pharmacogenetics arena,” says David Ludvigson, president and COO of Nanogen. “The program has potential to lead to the development of new prognostic and diagnostic reagents and also to provide licensing opportunities for new drug targets.”
Contact: Nanogen Inc (877) 626-6436; www.nanogen.com
Lawmakers to Introduce Legislation to Protect Patient Access to Lab Tests
A bipartisan group of lawmakers held a Capitol Hill press conference last month to introduce legislation that would ensure that the 43 million Americans on Medicare would have access to the latest advances in diagnostic laboratory testing.
The bipartisan Advanced Laboratory Diagnostics Act of 2006 was sponsored by Rep Michael Ferguson (R-NJ), Rep Phil English (R-PA), Rep Mike Thompson (D-IL), and Rep Bobby Rush (D-IL).
“This important legislation will begin to bring the 22-year-old Medicare payment system in line with 21st century medical science,” says AdvaMed President and CEO Stephen J. Ubl. “With breakthroughs in molecular diagnostic testing increasing our ability to pre-empt and more precisely treat disease, our society cannot afford to have outdated Medicare payment policies standing in the way of these advances.”
According to Ubl, the time is right for Congress to consider and pass this legislation. The Institute of Medicine, The Lewin Group, and the HHS Secretary’s Advisory Committee on Genetics, Health, and Society have all concluded that the current system is flawed, complex, and does not efficiently incorporate new technologies.
By failing to recognize that new tests may offer greater benefits to patients and physicians, the current Medicare Clinical Laboratory Fee Schedule provides few incentives for laboratories and health care providers to adopt new tests, according to Ubl.
Medicare reimbursement for an advanced viral load test for Hepatitis C illustrates the problem with this flawed system, according to Ubl. Medicare reimburses laboratories that offer the Hepatitis C viral load test less than the cost of performing the test and only half the amount of performing an HIV viral load test, which requires an identical series of complex steps and resources. Hepatitis C viral load testing measures the amount of virus in the patient’s blood and helps the physician determine the effectiveness of drugs used to treat the disease, which affects nearly 4 million people in the United States.
Ubl says that Medicare’s outdated system does not consider the technological sophistication of a new test, the resources required to run it, and the value of the test to patient care. Current policies also do not allow for the correction of payment errors.
The bill will reform Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests. It aims to:
• Establish a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests that would: reflect the value of these important technologies to patient care management, reduce long-term health care costs, and improve overall health care efficiencies;
• Improve current processes for obtaining adequate reimbursement for new clinical diagnostic lab tests;
• Provide more transparency with respect to Medicare reimbursement decisions; and
• Afford timely correction of historic payment errors that often lead to inadequate payment.
Contact: AdvaMed (202) 783-8700; www.advamed.org
IntellePro Releases Programmable Multi-Probe Head For Lab Automation
IntellePro Inc has expanded its product offering to include an ultracompact, programmable displacement head featuring 9-mm probe centers and strokes up to 125 mm. The pipette automation system includes Maxon motors with planetary gear-reduction driving helical racks, encoders, and encoder feedback to ensure smooth servo controlled displacement motion plus recirculating linear bearings for precision and repeatability.
IntellePro technology employs a helical rack and pinion with the drive motor parallel to the rack’s major axis. This design reduces head size and part count to extend the reliability and life of the pipette automation system. A typical linear pipette head contains eight probes on 9-mm centers with other configurations, such as probe adapters, custom built as requested. In addition, the system’s resolution is governed by reduction gear ratio and rotary encoder line count to easily adjust for unmatched performance in speed, smoothness, and resolution.
A leader in pick-and-place technology, IntellePro integrates customer specifications to develop optimized and cost-efficient solutions. Engineers either use off-the-shelf products or create innovative equipment designs based on customer need.
Contact: IntellePro Inc (908) 735-0537; www.intellepro.com
Brockville General Implements Misys CPR
Brockville General Hospital (BGH), a 103-bed acute-care facility located in Brockville, ON, Canada, has deployed Misys CPR™, a computer-based patient-record system, only 4 months after signing the contract to purchase it. The implementation of Misys CPR will give BGH’s staff of 600 the ability to access patients’ comprehensive medical records across departments, which will enable them to make more informed clinical decisions.
“Bringing an enterprisewide system live is a monumental undertaking and one that seems a bit overwhelming as you begin it,” says Alasdair Smith, CIO/CFO, BGH. “The implementation of Misys CPR within Brockville General Hospital was successful because of the exemplary commitment from both Misys and the hospital’s dedicated and very motivated project team.”
The rapid, phased implementation to replace BGH’s 15-year-old legacy system began in December 2005. Today, Misys CPR functionality is being used live in the laboratory, radiology, and patient-registration departments, as well as in parts of the hospital’s pharmacy and across the medical-records system.
After the second phase is completed, which is expected by this fall, BGH’s administrators aim to have its physicians using the computerized physician order entry feature within Misys CPR to efficiently place orders, track medication administration, and improve clinical and business-reporting capabilities.
Misys CPR is one of several products within the Misys Optimum™ family, a line of products designed to achieve interoperability through the sharing of patient information across organizations, health care settings, and technical solutions. Using Misys CPR or other Misys Optimum solutions, physicians and staff work in a connected health care environment, leading to improved efficiency and patient care.
Contact: Misys (800) 877-5678; www.misyshealthcare.com
