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Sep 1, 2009 (Vol. 29, No. 15)

Changing the Face of Clinical Medicine

Novel Technologies Take Aim at the Astronomical Cost of Healthcare

  • Immune Response

    Invitrogen, a division of Life Technologies, announced the global availability of the PlexMark™ 3 renal biomarker panel assay, a new biomarker tool for use in preclinical kidney function research. It is expected to assist in the development of more effective methods to monitor kidney health in transplantation protocols.

    This new assay provides researchers with an alternative to the invasive and expensive biopsy procedure by measuring levels of cytokines, chemokines, and receptor levels in urine as proxies for monitoring immune function and response.

    The PlexMark assay uses Luminex xMAP® multiplexing technology for bioassay analysis, while the biomarkers in the panel are licensed from Renovar.

    Globally, more than 30,000 persons receive kidney transplants each year. These recipients must contend with the intrinsic rejection mechanism triggered by the graft and the cumulative cell and tissue damage caused by the immunosuppressive drugs. Given that kidney damage may already be advanced by the time a biopsy is performed, utilizing urine biomarkers and tracking therapies early in the course of rejection are essential for improving care for transplant patients.

    Invitrogen also offers Dynabeads for in vitro diagnostic assays. These uniform magnetic beads are employed for a range of applications and are manufactured according to relevant regulatory requirements. The monodispersity and superparamagnetism of the Dynabeads allows optimal behavior in automated systems, according to Traci Moritz, senior manager for business development at Life Technologies. “Our experience with this technology has enabled us to build in lot-to-lot consistency in the broad range of the Dynabead product line,” she said.

    New product introductions include the MyOne product line, which employs a one-micron bead providing increased surface area, as well as Dynabeads Silane for use in molecular diagnostics. The scalability of the beads lends them to automation, noted Moritz. 

  • New Kits Speed Mass Spec

    Click Image To Enlarge +
    Water’s Acquity UPLC (left) and TQD mass detector (right) are used to perform immuno-suppressant drug analyses with the firm’s new Mass-Trak Immunosuppressants XE RUO Kit.

    Waters has addressed the demand for measuring levels of a whole family of immunosuppressive drugs, whose use has greatly expanded in recent years. According to Mark Bruns, Ph.D., senior director for the clinical business operation, the company has introduced a new product for quantitative measurement of tacrolimus, sirolimus, everolimus, and Cyclosporin A. Known as the Waters® MassTrak™ Immunosuppressants XE RUO (Research Use Only) Kit, it provides laboratories an alternative to immunoassay test kits for research laboratory analyses. Included in the kit are reagents, internal standards, and an analytical column for performing up to 500 determinations per kit.

    Dr. Bruns stated that the kit performs well in the presence of drug metabolites and addresses some of the analytical weaknesses of immunoassay technology. Currently, FDA-approved clinical tests include a kit to quantify the immunosuppressant tacrolimus in kidney and liver transplant patients by liquid chromatography-mass spectrometry (LC/MS/MS).

    Vitamin D deficiency has received much attention in the scientific and lay press in recent years. Associations with an increased risk of osteoporosis, heart disease, diabetes, and other maladies have driven a 90% increase in testing for this condition since 2007. Whereas the mechanisms of the vitamin D protective effects are complex and not completely understood, one overriding explanation resides in the fact that it is a potent inhibitor of the proinflammatory response and slows the turnover of leukocytes.

    A National Health and Nutrition Examination Survey caused researchers to conclude that low levels of vitamin D were associated with a generalized increase in mortality. Among many factors that may be responsible for vitamin D’s apparent beneficial effect on all-cause mortality is its effect on telomeres and its potential effect on slowing aging.

    Waters offers a new MassTrak system platform optimized for 25-Hydroxyvitamin D analysis for clinical research laboratories featuring a robotic liquid-handling system and Waters’ Acquity TQD System for high-throughput measurement of total 25-Hydroxyvitamin, as well as 25-Hydroxyvitamin D2 and D3. The platform is streamlined by a solid-phase extraction sample preparation step that minimizes solvent usage.

    Another MassTrak product, the Amino Acid Analysis Solution, is offered as a comprehensive research tool for the analysis of physiological amino acids in urine and plasma. This product incorporates a Waters’ Acquity UPLC system with pre-packaged reagents and consumables, for application in the clinical research laboratory. The platform permits the analysis of amino acids in approximately one-third the time of traditional amino-acid analysis, Dr. Bruns said.

    Finally, in the realm of clinical toxicology, LC/MS/MS is now widely used in confirmation analysis, due to its greatly simplified pretreatment requirements. At the meeting, Waters exhibited the Acquity UPLC system and tandem mass spectrometry products for the research and clinical laboratory, with many facilities using the technique for a variety of applications including toxicology, therapeutic drug monitoring, and endocrinology.

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