Magellan Biosciences Companies to Feature Diagnostic Products Designed to Improve Health Outcomes at the Clinical Lab Expo

Visitors to Booth 3210 at the 2008 AACC/ASCLS Clinical Lab Expo will see Magellan Biosciences’ continued emergence as a new leader in clinical-diagnostics markets worldwide. The Chelmsford, Massachusetts-based company and its subsidiaries, ESA Biosciences, Dynex Technologies, and TREK Diagnostic Systems, will feature products designed to help doctors make better, faster, more-informed treatment decisions with diagnostic assays and automated systems for the busy clinical lab, as well as a point-of-care system for the clinician’s office.

“Diagnostic testing accounts for less than five percent of healthcare spending, yet it influences some 80 percent of healthcare decisions, so a test’s accuracy, reproducibility, and consistency of results – regardless of who is performing it or where – is of paramount importance,” said Magellan President and Chief Executive Officer, Robert J. Rosenthal, Ph.D. “And while test volumes are growing dramatically, particularly in hospital-based labs, so too is the critical shortage of qualified laboratory personnel. Whether it’s measuring vitamin D sufficiency, which is vital to human health, performing susceptibility testing to help fight against MRSA and antibiotics resistance, automating ELISA assays to increase accuracy and reproducibility, or screening children to identify those at risk for lead poisoning – Magellan’s goal is always to develop a better, more cost-effective, and staff-efficient way to address a critical unmet need in the clinical marketplace and improve health outcomes.”

ESA Biosciences is launching a new FDA-cleared test to assess vitamin D sufficiency. Vitamin D deficiency is at epidemic proportions in the general population, yet recent studies link it to conditions ranging from cardiovascular disease, diabetes, and autoimmune disorders – to depression, stroke, and several forms of cancer. Consequently, physicians are ordering vitamin D tests in record numbers, straining the send-out budgets of many labs. Finally, there’s a practical, cost-effective alternative for clinical labs that offers significant improvements over other methodologies: the ESA Biosciences Vitamin D HPLC Test for the determination of 25-hydroxyvitamin D in serum or plasma. The ESA test, comprising reagent kit and test system, detects each form of vitamin D individually and automatically reports total 25(OH)D, with none of the antibody or protein-binding specificity issues associated with existing assays. The ESA Vitamin D HPLC Test provides accurate and specific results as demonstrated through comparison with other methods (HPLC-UV and LC-MS), but offers simplified extraction and lower samplevolume requirements. The ESA assay is reimbursable (CPT code 82306).

ESA will also feature its CLIA-waived LeadCare® II system, which makes blood-lead testing easy. Far simpler to administer than traditional blood-lead tests, the device can be used with a capillary or venous sample, can be combined with other routine waived blood tests, and saves administrative time spent on paperwork, tracking, and follow-up. Most important, it improves health outcomes – children with elevated blood-lead levels can receive immediate intervention, rather than waiting days or weeks for results and follow-up treatment from medical providers. LeadCare II tests are reimbursable (CPT code 83655) and cost-effective – allowing health systems to focus resources on those truly at risk.

TREK will demonstrate automated systems and assays that address the growing problem of antimicrobial-resistant organisms. The over-prescription of anti-microbial drugs (choosing a drug that won’t stop the bug) and inappropriate dosing both contribute to expanding resistance. As a consequence, today’s infectious-disease doctors are insisting on susceptibility testing to determine the lowest concentration of drug that will completely inhibit microbial growth (MIC value). TREK’s Sensititre® Automated Susceptibility and Identification Testing System delivers MIC values on the toughest bugs, and labs can test – on a single cost-effective, LIS-compatible system – more FDA-cleared antimicrobial therapies than any other platform (240+) against the widest range of non-fastidious and fastidious bacteria and yeasts. Sensititre can accurately detect and report MRSA (methicillin-resistant Staphylococcus aureus), VISA (vancomycin intermediate Staphylococcus aureus), VRE (vancomycinresistant Enterococci), ESBL (extended-spectrum β-lactamase), and KPC (Klebsiella pneumoniae carbapenemase) isolates.

The new VizionTM System* adds easy-to-read digital imaging capability. Sensititre’s advanced automation takes the guesswork out of reading susceptibility results. More accurate than manual processes, it saves labs time and money, eliminating the need for multiple off-line test procedures. Since Sensititre is the susceptibility platform that pharmaceutical companies use in their drug-development process, TREK has early access to the latest antimicrobial therapies. And Sensititre is also the system-of-choice for global surveillance programs, including NARMS (National Antimicrobial Resistance Monitoring System). TREK’s award-winning VersaTREK® Automated Microbial Detection System will also be on view.

Dynex is introducing several enhancements to its well-known DSX® automated ELISA processing
system:
• A new dual-wash mode capability allows users to run simultaneously, in any combination, up to four microplates of the latest bead-based molecular assays using filter plates, or traditional ELISA assays using solid-bottom plates. For bead-based assays, an adjustable vacuum manifold provides optimal bottom aspiration of a variety of plate designs and filter pore sizes to assure critical levels of accuracy, reproducibility, and throughput.
• Dynex’s new DSX reagent barcode scanning feature helps save time, effort, and reduce reagent identification error rates.
• Cost-saving deep-well strips for sample dilution let labs use only what they need for their assay run, eliminating waste from discarding partially used deep-well blocks.

Dynex is also launching new custom design and engineering services for assay/kit manufacturers. The automation experts behind the celebrated DSX and DS2® systems can develop custom components, or a complete automated system tailored for the specific application, and partner with the kit manufacturer to take the resulting product from initial concept through successful commercial launch. Visitors to the Clinical Lab Expo can also see demonstrations of the DS2 two-plate ELISA processing system.