Dynex Partners With The Binding Site
In an effort to expand its presence in clinical diagnostics markets, Dynex Technologies, a Magellan Biosciences company and developer of advanced microplate instrumentation, has expanded its relationship with The Binding Site Inc to market Dynex’s automated DSXTM walk-away workstation. The Binding Site Inc will combine its full range of ELISA kits and reagents along with exclusive 24/7 service and support as part of a complete laboratory solution for automation of autoimmune and infectious-disease assays.

“We are working hard to expand our presence in the clinical diagnostics market, and this marketing-partnership agreement between Dynex and solutions partner, The Binding Site, is an important example,” says Magellan CEO and President Robert J. Rosenthal, PhD. “We are also pursuing technology-licensing agreements, acquisitions, and building on our existing technology platforms to develop novel clinical laboratory and point-of-care products.”

“We’re very pleased to continue our long-term relationship with The Binding Site as part of our strategy to partner with premier providers to expand the reach of our technologies and serve clinical customers better,” says Dynex President Henry O’Connell. “We designed the DSX to be an open system so clinical laboratories can have the flexibility they need to run virtually any ELISA assay.”

“Dynex’s products have been an important part of our offerings to customers for the past 5 years,” says Anne Grainger, The Binding Site’s vice president of sales and technical services. “Now, through this expanded agreement, we can better serve our customers with our entire range of autoimmune and infectious-disease ELISA kits, and by providing the technical expertise to fully realize the potential of the DSX as an open-system platform. In addition, customers will receive exclusive 24/7 technical support through service partner Excalibur Lab Specialists.”

Contact: Dynex Technologies Inc (800) 288-2354; www.dynextechnologies.com

 ESA Corona CAD Wins Award
The Corona™ CAD (charged aerosol detector) from ESA Biosciences has won R&D Magazine’s 2005 R&D 100 Award. The Corona is a breakthrough, universal detector technology for high performance liquid chromatography (HPLC).

The winning of an R&D 100 Award “provides a mark of excellence known to industry, government, and academia as proof that the product is one of the most innovative ideas of the year,” says Tim Studt, editor in chief of R&D Magazine. This is the second time since its introduction in October 2004 that the Corona has received high honors. In March, the Corona won the 2005 Silver Pittcon Editors’ Award for best new product.

“I would like to thank all those who worked on this important project—and that includes our customers who provided valuable input throughout its development, first outlining what their ideal instrument would comprise, and then testing to ensure that the Corona met their rigorous demand,” says ESA President Walter DiGiusto.

The Corona CAD simultaneously offers excellent sensitivity, wide dynamic range, superior reproducibility, more consistent response, broad applicability, and intuitive operation in one, rugged, cost-efficient, easy-to-use instrument.

Contact: ESA Biosciences (978) 250-7000; www.esainc.com

 Salicylate-SL Assay Approved for Testing With Human Plasma
Diagnostic Chemicals Ltd (DCL)’s liquid-stable, ready-to-use Salicylate-SL assay has received 510(k) clearance from the US Food and Drug Administration for use with human plasma. The assay now offers clinical laboratories a rapid, highly specific enzymatic method for the determination of salicylate levels in both serum and plasma. While many methods use the classic “Trinder Chemistry Reaction,” which relies on the nonspecific interaction between salicylate and ferric ions, DCL’s Salicylate-SL assay incorporates salicylate hydroxylase to provide a cost-efficient, specific, and easy method for salicylate determinations.

DCL’s Salicylate-SL assay offers an 18-month shelf-life stability, and is available in two distinct packaging configurations, which include a liquid-stable standard material. Additional quality-control materials are also available to fully support the assay. DCL’s Salicylate-SL assay is ideally suited for use with fully automated testing procedures, and an extensive listing of instrument applications is readily available for a number of chemistry analyzers.

Contact: DCL (800) 325-2436; www.dclchem.com

 Nanogen Awarded $2.5 Million NIH Grant
The National Institutes of Allergy and Infectious Diseases (NIAID), a division of the US National Institutes of Health (NIH), has awarded Nanogen Inc, developer of advanced diagnostic products, a $2.5 million grant over the next 5 years for a research project to develop a prototype fully integrated diagnostic system for clinical labs to identify infectious agents that cause sepsis and community-acquired pneumonia (CAP). The grant will enable Nanogen to develop improved molecular biological methods, miniaturize those methods, and demonstrate the performance of this new molecular diagnostic approach to diagnosing sepsis and CAP in a hospital laboratory setting.

Full laboratory workups to specifically determine the cause of sepsis or pneumonia from the large number of possible disease-causing bacterial and viral agents is time-consuming and expensive. In addition, broad-spectrum antibiotics, which may not effectively treat patients, are often administered while awaiting test results. Nanogen will use its proprietary chemistry and multiplex detection technologies, and will employ the Medical College of Wisconsin’s technologies and clinical and microbiological expertise. The goal of this partnership is to develop an automated diagnostic system that would rapidly detect a number of bacteria and viruses that cause sepsis and pneumonia in patients.

“In previous government grant programs, Nanogen greatly reduced the size of its instrument and integrated essential biological sample preparation, amplification, and detection technologies to design a sample-to-answer diagnostic system,” says Howard C. Birndoff, Nanogen’s chairman of the board and CEO. “This NIAID/NIH research program will further the design of a sophisticated prototype assay and instrument system, and sepsis- and pneumonia-detection panels, to help physicians expedite test results in the hospital lab and make better treatment decisions.”

Mortality from sepsis can range from 28% to 50%. In addition, pneumonia remains the seventh leading cause of death in the United States. Estimates of the incidence of CAP range from 4 to 5 million cases per year. Early identification and appropriate treatment of the underlying cause of sepsis and pneumonia will improve patient outcomes.

Contact: Nanogen Inc (877) 626-6436; www.nanogen.com

 PDI Launches School Health-Awareness Initiative
Professional Disposables International (PDI), producer of Sani-Dex ALC alcohol gel hand wipes, has developed a program to educate students about hand hygiene. As part of this ongoing school health-awareness initiative, Beth Newman, senior product manager for PDI, recently spent a day at a New York elementary school teaching students how to properly and effectively wipe their hands clean. After the demonstration, Newman tested the students’ skills by using a special germ-detecting lamp to show the multitude of germs that accumulate on their hands.

Contact: Professional Disposables International (845) 365-1700; www.pdipdi.com

 Acetaminophen-SL Assay Receives FDA Clearance for Plasma Testing
The enzymatic, liquid-stable, ready-to-use Acetaminophen-SL assay from Diagnostic Chemicals Ltd (DCL) has received 510(k) clearance from the US Food and Drug Administration for the quantitative determination of the drug in human plasma. The assay’s ability to now test both serum and plasma clinical specimens will benefit clinical laboratories.

Optimized for use on a variety of different instrument platforms, DCL’s Acetaminophen-SL assay is perfectly suited for use with fully automated testing procedures, with an extensive listing of applications readily available. Configured in three separate and distinct packaging formats, the assay provides clinical laboratories with a test kit that best fits their existing instrumentation and testing volume.

DCL’s Acetaminophen-SL assay also features 15-month shelf-life stability and offers superior performance characteristics with regard to accuracy, precision, and linearity. Separate quality-control and calibration materials are also available to fully support the assay.

Contact: Diagnostic Chemicals Ltd (800) 325-2436; www.dclchem.com

Ortho-Clinical Diagnostics Expands Its Testing Capabilities
Ortho-Clinical Diagnostics, a Johnson & Johnson company, has added user-defined assay software to its VITROS 5, 1 FS chemistry system. This expands the system’s testing capabilities, allowing laboratories to expand their test menus by developing their own test-method applications to complement the assays currently available on the system. This software feature further enhances the onboard testing capability and provides better work flow and workstation consolidation.

The software allows laboratories to program assay protocols using pre-formatted templates and to define their own protocols. Reagent packs for use with the user-defined assays are available for order. The software supports enzymatic colorimetric and turbidimetric assay methodologies on serum, plasma, urine, cerebrospinal fluid, and whole blood hemolysate samples. Multiple-calibration models are available, including linear regression, cubic spline, Logit/Log4, and Logit/Log5.

User-defined assay software is supported by all of the current features of the VITROS 5, 1 FS chemistry system, including MicroSlide technology for the highest reportable result efficiency; Intellicheck® technology for system monitoring, advanced clot and bubble detection management, and intelligent error reduction; and MicroSensor™ sample integrity assessment. User-defined assay software also uses MicroTip technology featuring disposable tips and cuvettes, which eliminates the maintenance, cost, and risk of sample and reagent carryover, and cross-contamination associated with traditional chemistry systems.

“Thousands of VITROS customers around the world have benefited from the convenience and accuracy of our MicroSlide™ dry slide technology over the past 20 years. The unique design of the VITROS 5, 1 FS has enabled us to offer both the advantages of our MicroSlide technology and the new MicroTip™ technology, which offers a convenient alternative approach to traditional wet chemistry—on the same platform,” says Stephanie Wells, vice president, worldwide marketing, clinical laboratory business for Ortho-Clinical Diagnostics. “Now, we are also able to provide even greater efficiency and flexibility by offering the user-defined assay capability so that customers themselves can add to the test menu. These continued enhancements reflect our significant investment in our VITROS product line and our ongoing commitment to our customers worldwide.”

Contact: Ortho-Clinical Diagnostics (908) 218-8667; www.orthoclinical.com

US and Canada to Link Health Databases
The Centers for Disease Control and Prevention (CDC) and the Public Health Agency of Canada recently signed an agreement to formally link their electronic databases in an effort to more quickly and efficiently halt outbreaks of food-borne illnesses. The CDC says the agreement was logical because of the links between the two countries and their food supplies.

Under the agreement, laboratories will be able to share genetic fingerprints of pathogens responsible for food-borne illnesses in real time, which should result in faster identification of problems and a faster recall of infected food.

Contact: Centers for Disease Control and Prevention (800) 311-3435; www.cdc.gov

 LifeScan Unites Entire Blood Glucose Offering Under OneTouch Brand
LifeScan Inc, a Johnson & Johnson company, has announced a significant name change for its blood-glucose monitors, data-management system, and accessories used in hospitals and institutional settings. This change is part of the company’s new vision for the Advanced Care Group, which provides innovative blood-glucose-monitoring technology to the diagnostic industry.

This new vision will focus on helping health care professionals advance care across the continuum for their patients with diabetes. As part of the new vision, all Advanced Care Group diagnostic products will now carry the OneTouch® name, which is currently used for LifeScan’s consumer products.

“The OneTouch name is one of the most trusted names in diabetes management,” says Glenn Johnson, vice president, Strategic Accounts and Advanced Care Group. “By unifying our hospital products under the OneTouch brand, we’re strengthening our role across the continuum of diabetes care.”

As part of its guiding vision, all of the Advanced Care Group’s products will be united under the new message: “OneTouch® Advances Care.™”

“We are constantly striving to make our products the most accurate, reliable, and easy-to-use diabetes-management solutions for professionals,” says Johnson. “From developing new data-management technology to exploring and redefining best practices, OneTouch Advances Care is the Advanced Care Group’s guiding message, and we reflect it in everything we do.”

Contact: LifeScan Inc (408) 263-9789; www.LifeScan.com

ASCP Annual Meeting Scheduled for Next Month
The 2005 American Society for Clinical Pathology (ASCP) Annual Meeting: Pathology Today will be held October 8–11 in Seattle. The program will include presentations in a wide variety of educational formats, many networking opportunities and social events, and exhibits. Former NASA astronaut Bernard Harris, PhD, will give the keynote address, “Space Exploration: The Human Equation.”

Another keynote presentation will be “The Genomic Revolution: Bringing Genes to Life,” by Eric D. Green, MD, PhD, director of the National Human Genome Research Institute at the National Institutes of Health. In the Arthur Purdy Stout Society keynote, Saul Suster, MD, FASCP, will address primary thymic epithelial neoplasms. The Anatomic Pathology Slide Seminar on urologic surgical pathology will be delivered by John N. Eble, MD, FRCPA, FASCP, and David Grignon, MD.

Contact: American Society for Clinical Pathology

(312) 738-1336; www.ascp.org

Mayo Medical Laboratories Awarded Contract for Testing Services
Mayo Medical Laboratories (MML), the reference medical laboratory for the Mayo Clinic, has signed an agreement with MedAssets, one of the nation’s largest supply chain-management companies.

The agreement identifies MML as an authorized provider of laboratory services to MedAssets’ member base from September 1, 2005, through August 31, 2008. MML specializes in esoteric laboratory testing for health care organizations throughout the United States and around the world. MML provides esoteric laboratory testing to local health care providers while supporting the community practice of medicine. It provides the professional consultation necessary to direct and interpret complex test results. Additionally, MML provides only those tests not available in local hospitals and clinics.

“Physicians and their patients in the MedAssets membership have the option to use community-based laboratory services, optimize costs, and improve the quality of patient care,” says Robert Kisabeth, MD, senior vice president of medical affairs for Mayo Collaborative Services Inc. “MML works with providers to lower the costs of episodic care and keep revenue in the community. This is accomplished through outreach support, improved turnaround time, and consultative support on difficult cases. MML helps capture and retain local services through its proven, repeatable, predictable service offerings. We are grateful for this opportunity to complement MedAssets’ efforts in maintaining health and caring for the sick.”

“The addition of Mayo Medical Laboratories to our contract portfolio is consistent with our efforts to increase our members’ cash flow by enhancing revenue. MML provides tools that help ensure viable hospital outreach laboratory services programs,” says Mark Miriani, senior vice president, Supply Chain Contracting Services, MedAssets Supply Chain Systems.

Contact: Mayo Clinic (800) 533-1710; www.mayoreferenceservices.org

Olympus TANGO Blood Bank System Is Now Available for Use in the United States
The US Food and Drug Administration (FDA) has cleared the TANGO® automated blood bank system from Olympus America Inc for use in the United States. The FDA has also licensed blood grouping and antihuman globulin reagents specifically formulated and manufactured exclusively for use on the TANGO instrument. The TANGO system is designed for transfusion services, donor centers, and reference laboratories performing blood group serology testing. It is capable of performing a host of functions, including blood group determinations, antibody screening, and donor ABO/Rh confirmation testing. The TANGO system, manufactured by Biotest AG in Germany, is already widely used in Europe.

“This is an extraordinary development, not only for Olympus, but for the entire blood-banking arena,” says Stephen Wasserman, group vice president for the Olympus America Inc Diagnostic Systems Group. “TANGO offers outstanding flexibility, value, performance, accuracy, and ease of use to transfusion services, with enhanced specificity and sensitivity. There is already substantial pent-up demand for the system.”

With a throughput of approximately 190 wells per hour, depending on the test configuration, TANGO provides laboratorians with a more efficient tool in areas where real estate is tight and functionality is key. The benchtop analyzer measures 4.2 x 2.2 x 2.4 feet and weighs 286 pounds. The TANGO automates positive sample identification; recording of reagents (lot numbers, expiration dates); sample dilutions; reagent addition and mixing; incubation; washing; centrifugation; and result interpretation.

The system uses eight-well strips for flexibility and value. ABO/Rh testing is performed using strips containing dried antisera in the wells. Antibody screening is performed using a new solid-phase methodology that eliminates the need for indicator red cells as found in other solid-phase systems. Multiple configurations are available for the antibody screen testing (pooled, two-cell, and three-cell screens). In field trials, this methodology showed superior or equivalent specificity and sensitivity when compared to all reference methods.

For greater flexibility, TANGO systems also feature batch and random access operating modes and STAT sample interrupt. For easy use and maximum efficiency, it will use a Windows® 2000 operating system, Pentium® processor, touch screen interface, and image-analysis software.

Olympus will offer a variety of acquisition options, including leases, cost-per-test programs, and outright instrument purchase.

Contact: Olympus America Inc (800) 628-7152; www.olympus.com

Olympus to Build New Manufacturing Center
Olympus will double its capacity to produce clinical analyzers with a new manufacturing, research, and development facility scheduled to open in Mishima, Japan, in 2007. The new Mishima facility, at the base of Mt Fuji, will serve the growing worldwide market for Olympus analyzers.

“The newly designed and expanded manufacturing and R&D operation in Mishima will make it possible for Olympus to continue growing at a robust rate in the North American market,” says Stephen Wasserman, group vice president, Diagnostic Systems Group, Olympus America Inc. “We need the additional capacity to accommodate our current and planned rapid growth. The effects of this investment are vitally important for us, and will be beneficial for our customers in the United States.”

In addition to increasing the manufacturing levels for Olympus’ diagnostic systems, the new building, to be located at Nagaizumi, will also incorporate a new global research and development facility. R&D efforts for the company’s diagnostic instruments product line have been colocated with manufacturing since 2000.

The new three-story Mishima facility will have nearly 161,500 square feet of floor space and is expected to cost about $5.7 million to build. It will replace the current facility, which has been in operation since 1978.

Contact: Olympus (800) 645-8160; www.olympus.com

Ortho-Clinical Diagnostics Receives 510(k) Clearance for dHDL Assay
Ortho-Clinical Diagnostics, a Johnson & Johnson company, has received 510(k) premarket notification clearance from the US Food and Drug Administration for the VITROS® Chemistry Products direct high density lipoprotein (dHDL) slide. The assay, which is expected to be available on most automated VITROS chemistry systems in the fall, will be used to quantitatively measure high-density lipoprotein cholesterol (HDLC) concentration in serum and plasma.

“This new test offers all the performance advantages of dry slide technology with the added benefits of convenience,” says Stephanie Wells, Ortho-Clinical Diagnostics vice president, worldwide marketing, clinical laboratory business. “We continue to invest in our clinical laboratory business by developing and delivering new products to increase the menu available on our VITROS systems. This is the twenty-first new chemistry assay we have released in the past 9 months.”

According to the National Heart, Lung, and Blood Institute, approximately 37% of the US population is at high risk of developing coronary artery disease. HDL cholesterol tests are used along with other lipid tests to determine a patient’s risk for heart disease.

The VITROS chemistry products dHDL slide combines high-quality analytical performance with the advantage of a rapid, completely automated, random-access test, and does not require sample pretreatment. The dHDL MicroSlide selectively detects HDLC in patient samples, with test results available in 5 minutes using only 10 µL of serum or plasma. The test is performed in a single step, versus traditional dHDL assays that require multiple steps. Interferents such as triglycerides, LDL, hemoglobin, total protein, and a number of commonly prescribed medications do not affect the test’s performance. The VITROS chemistry products dHDL slide will be available for use on the VITROS 250 chemistry system, the VITROS 350 chemistry system, the VITROS 950 chemistry system, and the VITROS 5, 1 FS chemistry system.

Contact: Ortho-Clinical Diagnostics (800) 828-6316; www.orthoclinical.com

VISN 12 Awards Contract to Radiometer
The Veterans Integrated Services Network (VISN 12), Great Lakes Health Care System, has awarded a blanket purchase agreement to Radiometer America Inc. Under the 5-year agreement, VISN 12 hospitals will standardize their blood gas, whole blood oximetry, and STAT electrolyte testing using a comprehensive Radiometer solution that includes analyzers, services, and related products.

The seven hospitals within VISN 12 provide health care services to more than one million veterans residing within its four-state (Illinois, Michigan’s Upper Peninsula, Wisconsin, and Northwest Indiana) area.

“We are looking forward to offering Radiometer’s total blood-gas testing solution to the hospitals of VISN 12,” says Russell Christian, president, Radiometer America. “As their standardization partner, Radiometer will offer VISN 12 a comprehensive line of critical care testing products for both centralized and near-patient testing.”

Contact: Radiometer America Inc (800) 736-0600; www.radiometeramerica.com