Beckman Coulter Signs Agreement With Bio-Rad
Beckman Coulter Inc has signed an agreement with Bio-Rad Laboratories Inc for the development, manufacture, and distribution of infectious disease and blood virus assays. The agreement will enable Beckman Coulter to expand its portfolio of infectious disease and blood virus assays.

The assays will be available on all Beckman Coulter immunoassay systems, including the new UniCel™ DxI 800 Access® immunoassay system, which can perform up to 400 tests per hour.

“We want to continue to drive double-digit growth in the area of immunodiagnostics,” says Mike Whelan, vice president of immunoassay and nucleic acid testing for Beckman Coulter. “To achieve our goal, we are accelerating menu development through the establishment of relationships like this one with Bio-Rad. Consistent with our strategy, this particular agreement is significant because it facilitates our entry into the US infectious disease/blood virus market and enables us to complete our global coverage. Consequently, we will be able to offer to our customers in the United States the immunodiagnostic assays that we currently sell to international markets.”

Parkland and TREK Diagnostics Announce Blood Culture Equipment Agreement
Parkland Health & Hospital System has awarded a 5-year agreement to TREK Diagnostic Systems for the new VersaTREK™ Automated Microbial Detection System.

The VersaTREK System features the latest technology in automated microbial detection systems and allows technicians to conduct four tests on a single platform: blood culture, sterile body fluid culture, Mycobacterium detection, and M. tuberculosis susceptibility testing. The system offers enhanced ergonomics, uses TREK’s “Any Bottle anywhere Concept” (as easy as ABC) for maximum benefit, and features Microsoft® Windows-based software with one-touch access to all patient information and reports.

Says Nancy Lee, assistant manager, Microbiology Laboratory, Parkland Health & Hospital System, “When the Microbiology Committee members first began the search for new blood culture instrumentation, TREK emerged as the winning vendor based on technology and performance issues, and the overall cost-effectiveness of their product.”

“The VersaTREK platform will have a positive impact on detection and recovery, results reporting, logistics, instrument ease of use, and eliminating unnecessary costs,” says Tim Seekely, vice president, US Sales, for TREK.

Parkland Health & Hospital System, located in Dallas, Tex, has been recognized as one of the nation’s top hospitals for the 10th consecutive year by US News and World Report in its annual pick of the Top 100 Hospitals in the United States.

AACC Members Promote Telehealth in Meeting
With Presidential Advisor

A group of researchers that includes two AACC (American Association for Clinical Chemistry) members will meet with a representative of the President’s Council of Advisors on Science and Technology (PCAST) to address issues associated with home-based telehealth and advanced medical technologies. The group will meet with John Marburger, PhD, director, Office of Science and Technology Policy, and cochair of PCAST.

“Our goal is to make sure that the president and the Executive Branch are aware of the current status of medical technology and how home health care can meet the needs of an increasingly older US population and help address the rising expenditures on health care,” says AACC member Craig Lehman, PhD, professor and dean of the School of Health Technology and Management at Stony Brook University/SUNY and chair of the presentation group.

Many health care professionals agree that to keep costs down, the health care system must decrease use of costly services such as nonessential emergency room visits, hospital admissions, and extended nursing care services while increasing the use of telehealth technology. Craig Lehmann and his group will focus on a number of disease states most suited for telehealth applications, including diabetes, cardiovascular disease, and heart failure.

“In studies, telehealth technology significantly improves patient compliance when reporting vital signs and diagnostic tests versus traditional monitoring such as laboratory, office, or home visits,” says Lehmann. “Consistent and timely reporting improves disease management, affording health care providers constant access to patients and vice versa. For example, if patients transmit alarming vital signs and are instructed to proceed to the nearest hospital, practitioners are already in possession of their results and can begin lifesaving treatments as they save valuable time and avoid nonessential testing,” he explains.

Gen-Probe Files Premarket Notification Submission for the TIGRIS™ System
Gen-Probe Incorporated announced the filing of its Food and Drug Administration (FDA) Premarket Notification (510(k) application) for US marketing clearance for its fully automated, high-throughput molecular diagnostic instrument, the TIGRIS DTS™ System. In the clinical trial, equivalency between the TIGRIS System and existing semiautomated systems was shown using the APTIMA® Combo2™ Assay, Gen-Probe’s FDA–approved amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhoeae.

“Successfully completing the clinical trial for the TIGRIS System with the APTIMA Combo 2 Assay represents another first for Gen-Probe that will significantly improve the efficiency of testing for sexually transmitted diseases,” says Henry L. Nordhoff, chairman, president, and CEO of Gen-Probe. “Our goal now is to expand the menu of tests that can be performed on the TIGRIS System, including our blood screening and clinical diagnostics product lines.”

The TIGRIS System, which will ultimately be used in both the clinical diagnostics and blood screening laboratories, is the first diagnostic instrument to fully automate NAT testing. It has the ability to process up to 500 samples in an 8-hour shift and up to 1,000 samples in approximately 13 hours. The TIGRIS System is also expected to significantly reduce labor, maximize laboratory efficiencies, improve operator ergonomics, and reduce the risk of contamination associated with performing NAT assays. To accomplish these goals, the TIGRIS System is designed to integrate and automate all the steps associated with Gen-Probe’s latest amplified NAT assays, including sample processing, amplification, detection, and results processing.

New Research Identifies Chemicals That Could Cause Male Reproductive Disorders
Over the last 10 years, US researchers have observed a marked increase in some male reproductive disorders, including undescended testicles, increased instances of testicular cancer, and decreased sperm count. In the last 20 years the rates for testicular cancer have grown almost fivefold in Denmark, yet neighboring Finland has not experienced such a dramatic increase. In an effort to explain this phenomenon, scientists have hypothesized that these human male reproductive deficits may have a common origin: a disturbance in the level of androgen and other critical hormones during fetal development. The results from tests with laboratory animals may help scientists better understand the effect of fetal exposure to certain chemicals on male reproduction abilities later In life.

Paul M.D. Foster, PhD, of the National Institutes of Environmental Sciences, Research Triangle Park, NC, and his colleagues have coauthored a series of journal articles examining how fetal exposure to two common environmental agents affects the reproductive capabilities of some laboratory animals. Di-n-butyl phthalate (DBP) and linuron (L) can produce a range of reproductive effects in rats that are similar to the effects found in humans. Both agents have been related to the incidence of male birth defects and adverse development of male reproduction later in life in rats. The fact that they do so, albeit by differing mechanisms, is likely to help scientists better understand the nature of normal reproductive development.

In the studies undertaken by Foster and his colleagues, they discovered major malformations following the administration of the aforementioned antiandrogen chemicals during critical windows of in utero development (gestation days 12–21). The epididymal malformations were seen only in males after birth.

Foster believes that this research and similar efforts at other institutions will expand the attempts to determine how environmental and pharmaceutical antiandrogens may impact human development. The effects of antiandrogen exposure may not be uniform for a given population group. This suggests that research in this field should be linked to the ongoing effort to map critical developmental signaling pathways that determine why only some react to these selected agents.

Sysmex Awarded New Hematology Contract
Sysmex America Inc (SAI) has signed a 36-month contract, effective August 1, with Health Trust Purchasing Group (HPG) for the Sysmex hematology analyzers and supplies. Under the new agreement, Sysmex will sell and service the Sysmex analyzers and reagents to Health Trust members and affiliates. Health Trust is a national alliance of not-for-profit and for-profit hospitals. Sysmex will provide sales, marketing, training, and technical support from its offices in Mundelein, Ill.

    “We are very pleased that the Sysmex hematology products have been added to Health Trust’s portfolio,” says Kayuza Obe, president of SAI. “This agreement demonstrates the acceptance that Sysmex is gaining in clinical labs throughout the country. We now have the opportunity to offer the hematology products to many more clinical laboratories who value the reliability, efficiency, and exceptional quality that these products bring to hematology.”

Cable News Networks to Highlight Lipoprint Cholesterol Test
As part of National Cholesterol Awareness Month (September), Quantimetrix Corporation’s Lipoprint® Advanced Cholesterol Test will be highlighted on various cable news networks. Lipoprint, the only FDA–cleared test to analyze LDL size distribution, gives physicians a valuable tool to assess, treat, and monitor patients with the hidden risk of small, dense LDL particles. Recent evidence suggests that the risk for heart disease is strongly associated with the size and distribution of LDL particles. The small, dense LDL particles present a three-times-greater risk for heart disease.

Popularity of ASRs Increases, According to New Survey
Enterprise Analysis Corporation (EAC) of Stamford, Conn recently conducted a survey of molecular diagnostic laboratories to assess current testing practices and trends. A total of 51 laboratories were surveyed by telephone to explore issues such as types of tests performed, annual test volume and growth rates, use of FDA and non-FDA approved tests, ASRs (Analyte Specific Reagents) and home brew methods, test methods used, manufacturer market share, instrumentation used, recent assay additions, planned new assays, and interest in ASRs.

    Survey results indicated strong growth in the utilization of molecular diagnostic testing. In fact, 80% of those surveyed said they would add new molecular tests in the next 12 months. While home brew methods are widely used where FDA-approved kits or ASRs are not yet available, aboratories surveyed expressed considerable interest in using ASRs to replace home brew methods.

    Many laboratories reported double-digit increases in test volume for tests such as HPV, HIV genotyping, and HCV genotyping. Survey respondents also expressed a need for more automation to address growing test volumes, menu expansion, and the relative lack of laboratory personnel trained in molecular diagnostic methods.
New E-Learning Course on Cyclosporine
Beckman Coulter Inc’s latest Webinar for clinical laboratorians focuses on the therapeutic management of transplant patients. The 47-minute course, entitled “TDM of Cyclosporine: New Analytical Methods for New Clinical Concepts,” explores the basics of therapeutic drug management and explains in detail immunosuppressant therapy for organ transplant patients.

Hosted by Bernard C. Cook, PhD, DABCC, Beckman Coulter medical information scientist, the Webinar highlights the fundamentals of TDM, including its history and special aspects. In addition, the course describes the pharmacokinetics of immunosuppressive drugs and commonly applied monitoring protocols, such as trough, area under the curve, and C2 monitoring.

Viewers also will learn about available assay methods for immunosuppressive drugs, including chromatographic and immunoassay methods.

The Webinar is available at www.beckmancoulter.com/labquality under Personnel. It is accredited by the American Society for Clinical Laboratory Science Professional Acknowledgment for Continuing Education program. Participants will receive one unit for course viewing. Continuing education credits are offered at $20 per unit, while individual course viewing is free.