PerkinElmer and Luminex Join To Develop Solutions For High-Volume Disease Screening
PerkinElmer Inc and Luminex® Corp, a multiplex-solution developer, have announced a long-term licensing agreement to provide PerkinElmer access to Luminex’s xMAP® technology and the assay-development capabilities of the company’s bioscience group.

Under the terms of the agreement, PerkinElmer will use Luminex’s xMAP technology in several areas of life-science research and in vitro diagnostics. Focus areas are expected to include biomarker panels for pharmaceutical development and ADME/Tox, as well as development for in vitro diagnostics in maternal, neonatal, and prenatal health. PerkinElmer also plans to standardize its multiplex-assay development on the Luminex xMAP platform.

“Providing our customers with access to a proven multiplexing solution is essential to assist their specific research and development needs and long-term growth,” says Peter Coggins, PhD, president of PerkinElmer Life and Analytical Sciences. “We have selected Luminex’s xMAP technology as a recognized industry benchmark in multiplexed life science research and diagnostics applications. We look forward to working closely and collaboratively to benefit our respective customers.”

 Patrick Balthrop, Luminex’s president and CEO, comments, “This agreement with PerkinElmer is a prime example of our company’s growing emphasis on establishing long-term partnerships with market leaders in segments of strategic significance to Luminex. In this relationship with PerkinElmer we are not only providing new markets and customers with access to the Luminex xMAP technology, we are also partnering with a premier company with significant market presence. We are excited to have PerkinElmer on board and look forward to pursuing additional collaborative opportunities with them in the future.”

Contact: PerkinElmer Inc (781) 237-5100;

HemoSense Signs Agreement with ZyCare to Integrate Systems
HemoSense Inc has signed a marketing and distribution agreement with ZyCare Inc to integrate the use of its INRatio® PT/INR Monitoring system with ZyCare’s Web-based CoagCare® system for patient self-testing through physician practices and hospital clinics. INRatio is a portable Prothrombin Time/INR testing monitor, and CoagCare is the only remote INR test-reporting and dosage-management system for patients on oral anticoagulant therapy that has been cleared by the US Food and Drug Administration and is compatible with the Health Insurance Portability and Accountability Act of 1996.

 CoagCare helps health care professionals safely and cost-efficiently monitor patients who use INRatio remotely at home. After performing a PT/INR test with INRatio, patients use a standard Internet browser to input INR test results into the CoagCare system. CoagCare then provides automated, patient-specific warfarin dosage adjustments based on physician-prescribed algorithms. Test results are immediately available to health care providers. Patients who report out-of-range INR values or hemorrhagic or thromboembolic symptoms are prioritized for physician review.

“As a new distributor, ZyCare offers a unique benefit for our customers,” says Timothy Still, executive vice president of sales and marketing for HemoSense. “CoagCare automates much of the reporting and data analysis required for dosing adjustments that are typically handled by a physician, thus enhancing the physician’s ability to efficiently supervise patients using INRatio at home while freeing their staff to focus on the patients who need the most attention.”

Steve Holdaway, ZyCare’s CEO, adds, “We believe that the combination of INRatio and CoagCare will provide a powerful solution to increase physician confidence both to prescribe and manage warfarin patients, while offering a high level of convenience for patients, who are free to travel and report their results from any location with Internet access.”

Contact: HemoSense Inc (877) 436-6444;

Harvard Medical School and Lumera to Collaborate on New Protein Biochip
Lumera Corp has announced that is has entered into a collaborative agreement with Harvard Medical School (HMS) and the Harvard Institute of Proteomics, a division of HMS. Under the terms of the agreement, Lumera and HMS will develop a next-generation silicon chip substrate that combines Lumera’s NanoCapture™ technology with HMS’s nucleic acid programmable protein arrays (NAPPA™) methodology. The resultant 10,000-spot very-high-density protein arrays are expected to significantly increase the speed of drug-discovery and life-science research.

“The 10,000-spot biochip is a very important step toward our ultimate goal of producing a whole proteome biochip,” says Joshua LaBaer, director of the Harvard Institute of Proteomics. “As we increase spot density, we are able to gather more data about proteins from a single experiment.” The new Lumera protein arrays are critical to the bioscience and pharmaceutical markets that need faster methods for drug discovery, biomarker discovery, and solving complex problems in systems biology. Using current research methods and materials, array densities of up to about 800 spots are possible. However, with the new proprietary Lumera array, researchers will be able to analyze high-throughput expression of much more than 10,000 discrete proteins in biologically active arrays built from available cDNA libraries.

“Professor LaBaer’s work on protein arrays at the Harvard Institute of Proteomics has been substantial, and we believe it is revolutionizing proteomics,” says Lumera CEO Tom Mino. “They have shown the NAPPA platform as an extremely useful tool for biomarker discovery in cancer and diabetes, as well as for cutting-edge homeland bio-defense applications. We are very excited to be working with LaBaer and his team, as this represents a major milestone for Lumera’s bioscience technology.”

HMS’s NAPPA methods provide a simple, cost-efficient way to produce, as a single element of a microarray, freshly synthesized protein corresponding to any gene of known sequence. Combined with Lumera’s expertise in surface chemistry, the new biochip is expected to increase the NAPPA technology’s sensitivity and throughput by increasing the number of features on the array without sacrificing the amount of protein produced per feature. This avoids the cost and major technical difficulties involved in printing protein arrays one protein at a time.

NAPPA starts with a printed cDNA array and generates a self-assembled protein array using a combination of chemistries and biological methods. A cell-free expression mix produces proteins from the printed genes. The resulting expression product is immobilized on a surface-capture system providing for fresh, easily definable protein arrays made directly from cDNA libraries, and easily printed with commonly available equipment and methods. The arrays can be stored and easily handled, very much like today’s commonly used expression arrays. Protein is produced and captured only when the user is ready to use the array.

Although financial terms were not disclosed, HMS and Lumera will share the rights to jointly developed intellectual property under this agreement.

Contact: Lumera Corp (425) 415-6900;

Integrated Cytometry Solution Streamlines Lab Work Flow and Tracks Samples
Beckman Coulter Inc has introduced its integrated cytometry solution that standardizes and streamlines sample processing in flow-cytometry clinical labs. The solution manages and tracks electronic communications between the laboratory information system (LIS) and each sample-processing step, for increased efficiency, accuracy, and throughput. Walk-away process integration minimizes operator involvement, for significant time and cost savings and increased safety. The integrated cytometry solution features Beckman Coulter’s new FP 1000 Sample Processing System and FC 500 Flow Cytometer, along with LIS connectivity. The new solution simplifies work flow and tracks samples throughout the testing process—from receiving and preparing samples, to acquiring and analyzing data, to reporting results.

 With the new LIS-connectivity capability, sample ID and test requests are automatically downloaded to the FP 1000 Sample Processing System, eliminating manually prepared work lists. Barcode tracking on the daughter tubes provides paperless positive sample ID throughout the process and helps eliminate transcription errors and costly reruns. Manual pipetting of sample and reagents is also eliminated with the FP 1000’s automation features, which can process in either random access or batch mode. The system’s unique gripping arm transports carousels with daughter tubes automatically from storage to processing, and the system accesses sample tubes through cap piercing and automatically dispenses antibodies into the daughter tubes. This solution’s automation and integration advancements reduce technologist sample handling, for lower exposure to biohazards and reduced worker injury. Integration also limits individual steps for easier operation, less downtime, and reduced maintenance requirements.

After sample prep, the FC 500 flow cytometer’s CXP Acquisition Manager software can be easily populated with work list and sample ID information for acquisition and analysis of the sample. After review, results from the FC 500 are automatically uploaded to the LIS, for a complete process.

“This is the first time that the five steps of sample processing in flow cytometry have been electronically linked with automatic flow of information,” explains Bill Watkins, marketing manager for Beckman Coulter. “The linking of these steps is what makes our integrated, seamless solution a reality, transforming the complete work flow of the lab.”

Contact: Beckman Coulter Inc (800) 742-2345;

BioMérieux Exercises Second Option to License Gen-Probe’s RNA Technology
Gen-Probe Inc has announced that bioMérieux has exercised a second option to develop diagnostic products for certain undisclosed disease targets using Gen-Probe’s patented ribosomal RNA technologies.

In exchange for the right to develop products for these targets, bioMérieux will pay Gen-Probe a $2.1 million license fee. BioMérieux also retains an option to develop products for other disease targets by paying Gen-Probe up to an additional $0.9 million by the end of 2006.

 BioMérieux exercised its first option in January of this year and paid Gen-Probe a $4.5 million license fee, $1.9 million of which was recorded as license revenue in the first quarter. Based on the two option exercises, Gen-Probe will record another $1.9 million of license revenue in the fourth quarter of 2005, since accounting rules require that revenue be recognized based on the total number of targets eventually selected. This revenue recognition was expected and included in Gen-Probe’s financial guidance for 2005. The amount and timing of future license revenue that Gen-Probe records will depend on the number of additional targets, if any, selected by bioMérieux by the end of 2006.

Gen-Probe also will receive royalties on the sale of products that may be developed using the company’s intellectual property.

Contact: Gen-Probe Inc (800) 523-5001;

 Radiometer Selects HealthStream to Develop and Deliver Blood-Gas Education Programs
Radiometer America Inc has selected HealthStream Inc to develop and deliver Radiometer’s online blood-gas education program. The online education program will be delivered through a new customer-education portal, Radiometer University (, which will be built and administered by HealthStream.

Radiometer will work with HealthStream to develop a library of both accredited and product-focused online courses. The courses will cover subjects such as blood-gas-measuring principles, oxygen status, errors in the preanalytical phase of testing, and other topics related to blood-gas analysis. Initial rollout of the program is scheduled for the first quarter of 2006.

Radiometer will distribute the accredited and product-focused courses through HealthStream’s HospitalDirect, an innovative software tool set that provides a gateway to HealthStream’s 1,100 hospital network. Through HospitalDirect, Radiometer’s education program will be offered to current Radiometer customers as well as the approximately 1.23 million health care professionals contracted to train on HealthStream’s learning platform. Users will be able to purchase access to single courses or all courses as a subscription.

“Radiometer recognizes that continuing education and regular competency assessments are key to preventing errors and ensuring the highest-quality patient care,” says Anthony Colello, Radiometer’s manager of training. “The HealthStream partnership will provide our customers with an easily accessible educational portal to meet these critical training objectives.”

Contact: Radiometer America (440) 871-8900;

Bayer Announces Agreement With Catholic Healthcare Partners
Bayer HealthCare LLC has announced that its diagnostics division has been awarded an exclusive 7-year agreement with Catholic Healthcare Partners (CHP) for the supply of clinical chemistry; immunochemistry; and laboratory-automation equipment, reagents, service, and support. In the agreement, Bayer will supply CHP with 89 instruments from the ADVIA family of automated clinical laboratory solutions.

Cincinatti-based CHP encompasses more than 100 organizations, including acute care hospitals, long-term facilities, housing sites for the elderly, home health agencies, hospice programs, wellness centers, and other health care organizations in Indiana, Kentucky, Ohio, Pennsylvania, and Tennessee. CHP is composed of nine regions, which includes 28 hospitals.

 “We are looking forward to partnering with a dynamic, quality-driven system such as Catholic Healthcare Partners,” says John Nosenzo, senior vice president and general manager of the North American division of Bayer Diagnostics. “CHP’s goal is to achieve consistency across every laboratory within its diversified network of labs serving patients in five states. I am extremely gratified that CHP has the confidence that Bayer is up to supporting this complex challenge.”

“This is one of CHP’s largest laboratory-standardization initiatives,” says Darryl Long, vice president of supply-chain management at CHP. “With a network our size, standardizing our laboratories requires a partner that provides not only state-of-the-art instruments and reagents, but also breadth of knowledge and experience in laboratory quality, productivity, service, and support. I look forward to all CHP labs transitioning to Bayer’s chemistry and immunochemistry solutions.”

Contact: Bayer HealthCare Diagnostics Division (914) 524-2712;

Premier Awards Cardinal Health New Contract for Custom Procedure Items
Cardinal Health Inc was recently awarded a new 3-year national agreement to provide custom procedure trays, packs, gowns, and related items to members of Premier, one of the nation’s largest health care group-purchasing organizations. Cardinal Health estimates that Premier members will spend about $965 million over the course of the agreement.

The 3-year multisource contract will give Premier’s nearly 1,500 hospital members access to the industry’s broadest range of packs and trays with Cardinal Health’s Presource™ products and services. Premier members can also obtain a full range of surgical drapes, gowns, and other protective apparel through Cardinal Health’s Convertors® product portfolio.

“This is a vote of confidence in us and the products and services we provide to health care facilities nationwide,” says Thomas Bro, vice president of Health Systems for Cardinal Health. “We are pleased that Premier continues to demonstrate its faith in our long-term relationship by awarding us with this new contract.”

Hospitals across the country use Convertors® products to meet their clinical needs. The product portfolio includes drapes and gowns that meet the highest industry standards for barrier protection, along with a full range of nonsterile apparel and ancillary products. Cardinal Health’s Presource™ team offers a complete range of product solutions and works with providers to contain costs, standardize practices and componentry, and streamline their supply chain.

Contact: Cardinal Health Inc (800) 234-8701;

FDA Approves First West Nile Virus Quality Controls
AcroMetrix Corp has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the VeriSure® Pro West Nile Virus (WNV) external quality controls. These controls are for use with Chiron’s Procleix® WNV assay, which was cleared by the FDA in December 2005 for the testing of WNV using nucleic acid amplification. The FDA clearance allows these controls to be the first WNV controls to be marketed and sold in the United States for “in vitro diagnostic use” in blood screening.

WNV is a mosquito-borne virus originating in Africa, West Asia, and the Middle East that was first observed in the United States in 1999. Since 2003, more than 29 million units of donated blood have been screened for WNV in the United States. AcroMetrix external quality controls for WNV were selected by Chiron for use in clinical trials designed to evaluate the safety and effectiveness of a new screening test based upon the detection of WNV nucleic acid in donor blood.

“AcroMetrix provides blood-screening laboratories with the most advanced and comprehensive quality system for infectious-disease testing,” says Michael J Eck, CEO of AcroMetrix. “The approval of the AcroMetrix VeriSure Pro West Nile Virus external quality controls further demonstrates our commitment to help reduce the risk of transmitting this potentially deadly virus.”

Frequent testing of independent quality-control samples is expected to provide blood-testing centers with a means of monitoring the performance of the Procleix WNV assay. Routine use of the AcroMetrix WNV external quality controls can enable sites to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, to identify increases in random or systematic error.

Contact: AcroMetrix Corp (707) 746-8888;

NT-proBNP Test Added to Associations’ Practice Guidelines for Heart Failure
The American College of Cardiology/American Heart Association practice guidelines recently were updated to include the NT-proBNP test for the diagnosis of heart failure and the management of heart-failure patients. The guidelines specify that the use of proBNP is highly recommended in the evaluation of patients presenting within the emergent care setting when heart failure is suspected.

Roche Diagnostics currently offers the NT-proBNP test to detect the NT-proBNP peptide level as an aid in the diagnosis of congestive heart failure (CHF) in patients. It also can assess risk stratification in CHF and in acute coronary syndrome.

“Roche Diagnostics is committed to improving patient care, and the NT-proBNP test has proven clinical utility in diagnosing heart failure,” says Andrew Thomson, senior vice president of centralized diagnostics, a business unit of Roche Diagnostics. “This new version of the AHA/ACC guidelines is the first to include any of the natriuretic peptides, which shows that they are established markers in cardiac care. In the United States, more than 4.9 million people have congestive heart failure, and there are more than 500,000 new cases each year. These new guidelines may help determine earlier detection of CHF, which may benefit and improve outcomes for both patients and physicians.”

“The ACC/AHA guidelines spell out the most up-to-date understanding of the optimal care we can deliver to our patients with heart failure, and we, as clinicians frequently turn to them for guidance,” says James Januzzi Jr, MD, FACC, assistant professor of medicine at Harvard Medical School and codirector of the coronary care unit at Massachusetts General Hospital. “The guidelines thus represent the foundation for excellence in clinical practice. Importantly, prior to changing the guidelines to incorporate new technologies offering diagnostic or prognostic information, a rigorous evaluation of those technologies is mandatory.”

Contact: Roche Diagnostics (317) 845-2000;

European Union Clears CeMines’ Clinical Diagnostic Test For Lung Cancer
CeMines Inc has announced that its wholly owned subsidiary, CeMines International Inc, CeMines Estonia OÜ, has received notice from the State Agency of Medicines–Department of Medical Devices that the company was granted CE Mark registration and clearance for clinical use of its CellCorrect™ LAb Detection Kit, a minimally invasive molecular blood test to aid physicians in the detection and diagnosis of lung cancer.

The test will be marketed and distributed in the European Union under the brand name, CellCorrect KvA-40 LAb Kit.

“Our regulatory clearance in the EU, CE Mark registration, represents the culmination of an outstanding effort by the CeMines team,” says Roger Attick, president and CEO of CeMines. “This company milestone is without a doubt our most significant accomplishment to date. Further, CE Mark registration validates physicians’ demands for more accurate, less invasive (lower risk), and cost-efficient options that aid in the diagnosis of lung cancer. Most importantly, the CE Mark registration validates that our CellCorrect LAb Kit (CellCorrect KvA-40-LAb Kit) is a simple-to-use, cost-efficient, and powerful test. We believe that our integration of the CellCorrect diagnostic array protocol and CeMines’ Molecular FingerPrinting™ bioinformatics applications will eventually establish the CellCorrect product family as the most cost-efficient and operationally efficient DX modality available today.”

In the United States, CeMines announced May 16, 2005, that it had filed a 510(k) application with the US Food and Drug Administration (FDA), seeking regulatory clearance for clinical use of CellCorrect LAb. CeMines reports that it has held “productive discussions with the FDA,” and, as a result, “CeMines is proceeding in a direction that the company hopes will result in substantial forward progress later in 2006,” Attick adds.

CellCorrect LAb test kits (CellCorrect KvA-40-LAb Kits) detect altered autoimmunity and associated patterns (Molecular FingerPrinting) of disease-related autoantibodies in the bloodstream that are produced by the immune system upon the detection of cancer. CeMines has conducted international patient studies that have demonstrated that consistent patterns of specific biomarkers have proven their utility as viable composite biomarkers necessary to differentiate and characterize cancer. The company uses a patent-pending, proprietary bioinformatics application for biomarker analysis, followed by specific pattern-recognition algorithms. The data is presented in an easy-to-read ‘score format,’ not requiring subjective interpretation by physicians.

“Our team of medical-device, therapeutic, and diagnostic experts is honored to have had the privilege of managing the CE Mark application process for CeMines’ novel product family, CellCorrect,” says Daniel Spasic, CEO of Trial Form Support (TFS). “Given that CeMines is developing an impressive pipeline of important oncology products to satisfy a huge medical need throughout the EU, TFS is very enthusiastic about managing the regulatory-approval process for other CeMines tests in the development pipeline for Europe.”

Contact: CeMines Inc (858) 964-2204;

Teaching Hospital Upgrades with Mediware Solutions
New York University (NYU) Medical Center has selected Mediware’s HCLL™ Transfusion and HCLL™ Donor solutions to sustain the delivery of high-quality care in a safe environment.

“Our focus was a system designed with sound blood-bank principles and intelligent presentation of the data elements to our end-users,” says Mark Wheeler, blood-bank administrative director. “Mediware enables the technologist or supervisor to have immediate access to patient data, including transfusion history, current testing readiness, special blood-attribute requirements, contents of inventory, and donor history.”

The blood bank has been deemed mission critical at NYU Medical Center and an integral component of the larger institutional commitment to be a technology leader. The medical center has recognized Mediware and its 20-year relationship as the cornerstone of the principal safety-control system of the blood bank, protecting patients, physicians, and blood-bankers from error.

“We wanted to leverage our investment in the historical donor and patient databases, maintain the highest standards of the donor and patient-safety inventory-control functions, and align ourselves with a partner who would support us well into the future,” Wheeler notes.

“The vision for patient safety that NYU Medical Center demonstrates is a model for all large-scale health systems,” says James Burgess, president and CEO of Mediware Information Systems. “Mediware’s commitment to patient safety shares this mission to eliminate error and variance from the care process. We are proud of our long-standing partnership with the medical center as they raise the standards and best practices for the delivery of health care.”

Contact: Mediware Information Systems Inc (913) 307-1000;

Luminex’s xMAP Receives 2005 Technology of the Year Award
Frost & Sullivan’s research service, Pharmaceuticals & Life Sciences, has selected Luminex Corp as the recipient of the 2005 Technology of the Year Award in clinical diagnostics for its advanced xMAP technology instruments. The versatile xMAP technology analyzes proteins, enzymes, oligonucleotides, receptors/ligands, and antibody/antigen interactions.

This award is presented each year to a company that has introduced a technology into the marketplace with innovative capabilities, influence, and impact over several market segments. Additionally, the award recognizes the company’s successful technology development and introduction that is expected to significantly contribute to the industry in terms of adoption, change, and competitive posture.

xMAP technology enables multiplexing, a powerful concept in biological testing that involves the simultaneous analysis of multiple assays. Multiplexing helps clinicians and researchers detect up to 100 single markers from a single sample in a single reaction.

“Luminex xMAP technology offers a very efficient method of performing multiplexing. It is also high throughput, or has the ability to analyze many samples in a short time, with up to 1,000 samples a day,” says Frost & Sullivan Research Analyst Martin Nejat. “xMAP’s innovative detection system also allows for high sensitivity and specificity, and the fluidic nature of the xMAP technology reaction allows any sample hybridization to be completed in a fraction of the time it takes for other multiplexing methods.”

The xMAP technology is based on multicolored microspheres, or beads, suspended in a liquid sample. Each unique color-coded microsphere can be coated with various reagents that enable simultaneous detection and quantitation of many analytes from a single sample. Unlike planar arrays, suspending the beads in the sample allows the technology to leverage the benefits of liquid kinetics, which improves the analysis’ uniformity and speed.

The beads are photoelectrically detected using complementary laser beams. Since each microsphere is individually identified and counted, the process provides high accuracy, sensitivity, and reproducibility. The medium multiplexing range of xMAP technology is ideal for labs interested in taking advantage of the data flowing out of projects like the Human Genome and HapMap projects. As sets of markets associated with different diseases are identified, the xMAP technology’s broad menu of applications and flexibility to custom-build assays have made it attractive to labs looking for clinical, genetic, and proteomic applications.

Many research labs have adopted the xMAP technology for various protein and nucleic acid purposes. As the technology moves into diagnostics, most US reference labs are expected to adopt Luminex instruments for their versatility, speed, clinical throughput, and ability to multiplex both protein and nucleic acid tests. xMAP technology is currently used for various clinical tests, including cystic fibrosis, infectious disease, and HLA analysis.

“xMAP technology has applications across the basic research, drug-discovery, and clinical diagnostics markets,” Nejat says. “The need for multiplexing is growing as the focus in genetic research and development and the clinical diagnostics market shifts toward multifactorial diseases.”

Contact: Luminex Corp (888) 219-8020;

 Johns Hopkins Hospital Implements Oral-Fluid HIV Screening Program
OraSure Technologies Inc has announced that the Johns Hopkins Hospital Department of Emergency Medicine has implemented an oral-fluid HIV-screening program in the emergency department (ED) of the Johns Hopkins Hospital using the OraQuick® ADVANCE™ Rapid HIV-1/2 Antibody test. The Johns Hopkins program, based in Baltimore, is one of the first in the nation to offer oral-fluid rapid HIV testing to any patient entering a hospital ED for evaluation or treatment. The US Centers for Disease Control and Prevention (CDC) and the Maryland Department of Health and Mental Hygiene provide funding for the Johns Hopkins program.

OraQuick ADVANCE is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick, or venipuncture whole-blood or plasma specimens. The test was launched by OraSure Technologies in October 2004 and has since been used by hospitals, state departments of health, clinics, community-based organizations, federal government agencies, and college/university health centers throughout the United States. According to the CDC’s 2005 Rapid Testing Model Performance Evaluation Program, OraQuick is now the most-used rapid HIV test in hospitals.

According to the CDC, more than 55% of patients tested in hospital EDs with laboratory-based HIV tests in the United States are discharged prior to receiving their test results, and only 10% of patients referred out to hospital clinics from EDs actually undergo testing.

Since the Johns Hopkins program was launched, more than 50% of all patients identified as HIV positive in this program were successfully moved into follow-up care and treatment.

“We are very enthusiastic about the success of the Johns Hopkins program, and in particular how this oral-fluid rapid testing program will enable those who screen positive for HIV to receive immediate care,” says Douglas A. Michels, president and CEO of OraSure Technologies. “A patient’s HIV status can dramatically affect diagnosis and treatment. This program will help doctors make more timely and better-informed clinical decisions, and will also permit HIV testing and follow-up treatment for individuals whose only contact with the health care system is through emergency departments. We look forward to the day when rapid HIV testing is routine in hospitals and other health care settings throughout the country. We applaud the Johns Hopkins Department of Emergency Medicine for taking a leadership role in this endeavor.”

According to the Maryland Department of Health and Mental Hygiene’s HIV/AIDS report from 2004, Maryland ranks ninth in the United States in reported AIDS cases, and more than 50% of the state’s new HIV cases were residents of Baltimore City at the time of diagnosis. Currently, more than 14,000 persons are infected with HIV in Baltimore City.

Contact: OraSure Technologies Inc (800) 869-3538;

Gen-Probe Awarded Prestigious National Medal of Technology
President George W. Bush has named Gen-Probe Inc a 2004 National Medal of Technology Laureate in recognition of the company’s pioneering work in developing innovative nucleic acid tests to safeguard the nation’s donated blood supply from viruses such as HIV-1 and hepatitis C.

The National Medal of Technology is the nation’s highest honor for technological innovation. According to the White House, it is awarded to individuals and companies who “embody the spirit of American innovation and who have advanced the nation’s global competitiveness.” Gen-Probe was one of seven recipients of the 2004 award, which was established by Congress in 1980 and is administered by the Department of Commerce. For more information on the National Medal of Technology, go to

A statement issued by the Department of Commerce recognizes Gen-Probe “for the development and commercialization of new blood testing technologies and systems for the direct detection of viral diseases.” In the statement, US Secretary of Commerce Carlos M. Gutierrez says, “I join President Bush in congratulating the 2004 National Medal of Technology laureates. Their creativity and willingness to take risks to achieve technological breakthroughs have helped make America the leader in innovation.”

 “We are honored to receive this prestigious award for innovation in protecting the donated blood supply,” says Henry L. Nordhoff, chairman, president, and CEO of Gen-Probe. “I would like to thank the hundreds of Gen-Probe employees whose talents, expertise, and extraordinary efforts made this recognition possible. We also received support from many external collaborators, including the National Heart, Lung, and Blood Institute, our blood bank customers, Chiron Corporation, and the US Food and Drug Administration.”

Contact: Gen-Probe Inc (800) 523-5001;

Diversa Corp Uses Electronic Laboratory Notebook Solution For Media-Preparation Procedures
Labtronics Inc has announced that Diversa Corp has chosen its NEXXIS qELN, an electronic laboratory notebook (ELN) designed specifically for QA/QC laboratories, to enforce its standard operating procedures (SOPs) during the media-preparation and execution of its production processes.

 Historically, Diversa’s media-preparation process has been paper-based and manual. NEXXIS qELN will allow Diversa to create electronic SOPs that interface directly to their laboratory instruments, eliminating manual transcription errors and ensuring complete compliance with all steps of the process. This will decrease laboratory operating costs and improve productivity by removing the need to monitor and confirm the accuracy of operator entry in the SOP. NEXXIS qELN will also increase their diligence on validation of regulatory runs, which is vital to Diversa as it continues to grow its business in regulated markets such as pharmaceutical, agriculture, and biotechnology.

Diversa also incorporated Labtronics’ chemical inventory management module, NEXXIS CIM, as part of the total solution to help it improve its chemical inventory tracking. NEXXIS CIM is fully integrated with NEXXIS qELN, allowing Diversa to automatically manage its inventory as chemicals are used during the SOP process of media preparation.

“As our business continues to grow, it is extremely important for Diversa to find ways to improve productivity in order to capitalize on that growth and maximize our profitability,” says Charles Isaac, director of Bioprocess Development at Diversa Corp. “Labtronics’ NEXXIS qELN solution will improve the productivity of our media preparation and execution of our processes, and ensure that we are in complete compliance with all of the regulations that our markets demand.”

“Today, the need for regulated companies to ensure total compliance with corporate SOPs is greater than ever, and Labtronics is responding to this need with solutions to automate and validate that SOPs are fully and accurately completed,” says Robert Pavlis, president of Labtronics Inc. “We are excited that an industry leader such as Diversa has turned to Labtronics to improve their SOP processes and bring them to the next level of productivity and regulatory compliance.”

Contact: Labtronics Inc (519) 767-1061;

Beckman Coulter and Consorta Sign Multiple Pricing Agreements for Clinical Lab Systems and Tests
Beckman Coulter Inc has signed agreements with Consorta to provide members of the health care resource-management and group-purchasing organization with clinical lab systems and tests.

The three contracts, valued at approximately $105 million over the next 5 years, include Beckman Coulter’s chemistry, immunodiagnostics, and automation product lines. Consorta also extended its hematology agreement—valued at $10 million per year—with Beckman Coulter for 2 more years.

“These agreements will provide Consorta care sites with access to our entire line of chemistry, immunoassay, hematology, and automation product lines,” says Robert Kleinert, executive vice president of US diagnostics commercial operations for Beckman Coulter. “The contract provisions include our new line of UniCel® systems, such as the DxC 600 and 800 chemistry analyzers and DxI 800 Access® immunoassay system, as well as our market-leading Power Processor automation system. Plus, Consorta members will benefit from an extensive menu of nearly 200 different reagent kits ranging from routine tests like cholesterol to specialty tests for cardiac, cancer, anemia, and more.”

“The flexibility and value that Beckman Coulter offers for clinical lab testing will help Consorta members achieve their goals for robust instruments that deliver reliable and accurate results,” says Lois Brisben, director of laboratory services for Consorta. “We are confident that our members and their patients will benefit from the company’s products and quality service.”

Contact: Beckman Coulter Inc (800) 526-3821;

Chemicon Enters Into License Agreement with RheoGene to Commercialize Products Using Inducible Gene-Regulation Technology
Chemicon International Inc and RheoGene Inc have signed a semiexclusive license to use RheoGene’s RheoSwitch® System and related technologies within Chemicon’s research product lines focused on specialty research markets, including Chemicon’s growing stem-cell biology portfolio of products.

Through this agreement, Chemicon accesses the innovative RheoSwitch technology that regulates the timing and level of gene expression in all types of eucaryotic cells through the interaction of RheoGene’s proprietary ecdysone-based receptors and proprietary small-molecule ligands, which will be supplied under the agreement. Chemicon will apply this technology both to generic cloning and expression reagents, and to important genes involved in cell-differentiation and development.

“Chemicon is looking forward to adding the RheoSwitch technology to our product-development capabilities” says Jeffrey D. Linton, president of Chemicon. “The new products that will be developed with this technology will greatly enhance our expanding portfolio of innovative tools for stem-cell research.”

“We are pleased to bring RheoSwitch gene-regulation technology into Chemicon’s research products and services business,” says Thomas Tillett, RheoGene president and CEO. “RheoSwitch technology will enable Chemicon to provide its customers with a broad range of proprietary cell-based gene-regulation products in their specialty research markets. We are excited about the potential for Chemicon to add RheoSwitch products for regulated gene expression and directed differentiation in pleuripotent and somatic stem cells to its rapidly growing stem-cell biology portfolio.”

This licensing agreement reflects the alignment of both organizations in their objectives to enhance the growth of their respective technology positions in the stem-cell field by offering high-quality products and services that advance the state of the art in their respective business sectors. Chemicon is bringing high-value specialty products to the research market, and RheoGene is developing regulated stem-cell-based therapies for treatment of human diseases.
Financial terms were not disclosed.

Contact: Chemicon International Inc (951) 676-8080;

MDS Sells Interest in Source Medical to Cardinal Health
MDS Inc has completed the sale of its interest in Source Medical Corp to its partner Cardinal Health for $79 million Canadian. Source Medical is a distributor of medical and surgical supplies to hospitals, laboratories, and other health care providers in Canada.

“The sale of our interest in Source Medical is the first step in focusing MDS on growth in the global life-sciences markets. We expect that the Source Medical team will continue to deliver solid performance under the full ownership of Cardinal Health,” says Stephen DeFalco, president and CEO of MDS Inc.

Cardinal Health, the leading provider of products and services to the health care industry, manufactures and distributes medical, surgical, and laboratory products worldwide. Through the acquisition of Source Medical, the company is better-positioned to serve its growing base of customers in Canada.

“Cardinal Health has a long history of serving health care providers in Canada,” says Ronald K. Labrum, Cardinal Health’s chairman and CEO of Healthcare Supply Chain Services. “Today’s announcement is another step in our strategy of bringing together excellence in supply chain innovation and efficiency to help improve the delivery of patient care.”

“As part of Cardinal Health, a global leader in health care, Source Medical will have new opportunities to strengthen our leadership in serving Canada’s medical community,” says David Lees, president and CEO of Source Medical.

Contact: MDS Inc (416) 675-7661;

 Consorta Signs Agreement With Bayer For Immunochemistry Products
The Diagnostics Division of Bayer HealthCare LLC has announced the signing of a 5-year trisource immunochemistry contract with Consorta Inc to provide instrumentation, reagents, consumables, and service to its membership. Consorta, with headquarters in Schaumburg, Ill, serves more than 2,400 care sites, representing more than 78,000 patient beds.

Bayer Diagnostics will make available its ADVIA Centaur, ADVIA Centaur CP, and ACS:180 immunochemistry systems. The contract will be effective for 5 years.

“This agreement is an extension of Bayer Diagnostics’ already successful relationship with Consorta,” says John Nosenzo, senior vice president and general manager North America, Bayer HealthCare. “Bayer continues its commitment to deliver innovative, high-quality platforms and world-class service.”

“We look forward to maintaining a strong relationship with Bayer Diagnostics,” says Lois Brisben, director of laboratory services for Consorta. “Their immunochemistry portfolio offers a breadth of efficient and economical solutions.”

Contact: Bayer HealthCare Diagnostics Division (914) 524-2712;

American Hospital Directory Offers Free Online Profiles
American Hospital Directory’s (AHD) data services now include free state-by-state listings of hospitals and their key statistics. Health care strategists and industry observers can use the new resource to establish benchmarks, such as number of total discharges and gross patient revenue, geographically. State-by-state summaries enable analysts to scrutinize regional trends and market dynamics.

The new geographic profiles can be found on the Internet; detailed hospital information and custom reports can be purchased from AHD.

The free hospital profiles include up-to-date information available online. Using innovative analytical techniques and evidence-based data sources, AHD has created comprehensive snapshots of more than 6,000 hospitals.

“Strategists now have ready access to key operational statistics for hospitals, states, and the nation,” says Paul Shoemaker, president of AHD. “AHD analysts update the data regularly from reliable sources, so researchers and health care executives can trust the information.”

Contact: American Hospital Directory (800) 894-8418;

Biotech Protects Critical Research and Operations Data With Asigra Technology
Morphotek Inc has begun using Asigra technology for disaster recovery and business continuation. Backup and recovery services are provided through Recovery Networks, a Pennsylvania-based service provider. The Recovery Networks solution leverages Asigra Televaulting™ agentless technology (rebranded as Recovery Networks BackupNet software) to provide high-speed, automated data backup and recovery via the Internet.

Morphotek focuses on the generation of proprietary organisms for product discovery and development. The organization uses its own patented morphogenics process to expedite DNA mutations that can be developed for drugs, agriculture, and other life-sciences or industrial applications. Morphotek scientists and biologists amass significant volumes of research data each day. The security and protection of this data, as well as the company’s mission-critical operations data, is essential to business continuity.

“Morphotek had the classic issues with traditional tape-backup methodologies—increasing amounts of critical data and decreasing reliability of mechanisms that utilized dated, legacy technology,” says Tom Dugan, CEO of Recovery Networks. “Recovery Networks’ assurance of a reliable backup service with zero data loss made Asigra Televaulting an easy purchase decision for Morphotek.”

All mission-critical data, from Exchange mail stores to SQL-based business databases and large research files containing microscope-generated images, is now protected and available online. WAN optimization features such as global file deduplication, incremental forever backups, and compression make online data retrieval efficient.

 A key security feature is that data is encrypted in flight and at rest. “Whether it’s a single mailbox or a 45-MB file, recovery is lightning fast,” says Andrew Kulp, IT manager at Morphotek. “With tape, we’d have been looking at a minimum of 15 minutes to recover a single file—and that’s after we located the correct tape set from local or off-site storage. Since we started using the Asigra technology, the largest restoration we’ve done completed in less than 5 minutes. If you need to recover data just twice a week, that’s a considerable savings in IT resources and user productivity.”

Most importantly, Kulp says that in the worst-case disaster scenario, recovery of critical data can be completed within 4 hours: “You might expect this level of service to be more expensive than tape-based solutions. But in reality, we now have a 4-hour recoverability service level, and the cost is more than offset by our savings in productivity, IT resources, tape hardware and media, backup-software licensing, and maintenance. And it’s no longer a case of ‘drop the tapes off at your door and hope they work’—Asigra backs up whatever is scheduled, and it’s guaranteed, every time. The speed is phenomenal.”

“The speed, security, and cost-efficiency of online backup and recovery service make it an ideal solution for research organizations like Morphotek,” says Eran Farajun, executive vice president of Asigra. “In these environments, data is king, yet IT resources are often in short supply. The Asigra Televaulting technology ensures the protection and availability of critical data, while freeing the IT staff to focus on research-related application and user services.”

“The Asigra technology gives us the ability to guarantee business continuity,” summarizes Kulp. “It’s been 100% faithful since we started. Morphotek users have no fear of losing critical research or operations data. Even though we’re adding new users and about 2 GB of new data each month, we’ve indefinitely postponed expansion of our administrative staff.”

Contact: Asigra (416) 736-8111 ext 101;

 Response Biomedical Reaches Performance Targets With Rapid Flu A Test Development
Response Biomedical Corp has announced that it has successfully achieved its analytical sensitivity targets for its flu A test. The test is to be commercialized for both human and animal applications. Using a variety of flu A strains, the performance results to date indicate that the RAMP flu A test produces results that are in excess of 100 times more sensitive than commercially available rapid influenza A tests.

This level of performance is important, as leading public health agencies continue to express caution about the lack of sensitivity and related performance limitations of currently available rapid flu A tests.

Response Biomedical also announced it has initiated development of a separate RAMP test to specifically identify only the H5N1 strain, the lethal form of avian flu that is spreading internationally and threatens to cause a global influenza pandemic. Early feasibility testing has produced encouraging results.

“Since announcing our plans on October 24, 2005, to commercialize a high-sensitivity flu A test, we have received tremendous interest from government organizations and the private sector,” says Bill Radvak, president and CEO. “These same organizations have expressed further interest in the prospect of a RAMP H5N1 test.”

As a result of these expressions of interest, Response Biomedical is entering into collaborations with several government health organizations and international members of the World Health Organization’s Global Influenza Surveillance Network. These national influenza centers will evaluate the sensitivity of Response’s rapid RAMP flu A test across numerous flu strains and measure the sensitivity and specificity of the RAMP H5N1 test for avian flu.

“In 2003, a similar collaboration with the US Centers for Disease Control and Canada’s National Microbiology Laboratory led to the RAMP West Nile Virus Test being validated as 100 times more sensitive than the leading commercially available rapid test within months of undertaking development,” Radvak adds. “Our goal is to replicate the RAMP West Nile Virus Test commercial model and become a market leader in rapid clinical infectious-disease testing by quickly validating RAMP’s significant performance advantages over available tests, and leverage this competitive advantage to attract the optimum distribution partners.”

Contact: Response Biomedical Corp (888) 591-5577;

ITC Collaborates With Medical Automation Systems
International Technidyne Corp (ITC) has extended an agreement with Medical Automation Systems (MAS) to integrate two of its point-of-care testing systems with the widely used RALS®—Plus data-management system, developed and markted by MAS.

The RALS-Plus Version 1.4 enables ITC’s IRMA TRUpoint® blood-analysis system and the HEMOCHRON® Signature Elite™ blood-coagulation analyzer to automatically manage, report, and electronically transfer patient-monitoring data to the RALS-Plus database and the hospital’s laboratory information system.

“Our customers want a connectivity solution,” says ITC President Lawrence Cohen. “The ability to interface both the IRMA

TRUpoint and the HEMOCHRON Signature Elite systems with the versatile and widely used RALS-Plus provides fast, efficient, convenient reporting and transmission of critical-care patient-testing data. IRMA TRUpoint and HEMOCHRON Signature Elite users in institutions already using RALS-Plus data management will now be able to integrate and manage blood-gas, electrolyte, and coagulation monitoring with other point-of-care tests through a single data-management system.”

“We are pleased to continue our relationship with ITC and provide our customers the ability to connect the IRMA TRUpoint and HEMOCHRON Signature Elite systems, as we have done for the HEMOCHRON Signature+ and Response systems,” says MAS President and CEO Greg Menke.

The IRMA TRUpoint is a portable analyzer that performs tests at the patient’s bedside. It measures pH, blood gases, hematocrit, electrolytes, creatinine, and other chemistries at various point-of-care settings, such as the operating room (OR), neonatal intensive care unit, intensive care unit (ICU), critical care unit (CCU), or wherever the patient is located, so critical treatment decisions can be made without delay.

The HEMOCHRON Signature Elite point-of-care microcoagulation-monitoring system is an enhanced version of the widely used HEMOCHRON Signature+, with new features that include internal electronic quality control and bar-code scanning of patient and operator information.

The HEMOCHRON Signature line offers the industry’s most extensive point-of-care test menu for coagulation monitoring with assays for ACT+, ACT-LR, PT, citrated PT, APTT, and citrated APTT. The broad menu of tests is used in a variety of hospital locations, such as the cardiovascular OR, cardiac catherterization, ICU, CCU, and anticoagulation clinics.

Contact: International Technidyne Corp (732) 548-5700;

New Web Portal For Confocal Microscopy
Nikon Instruments has unveiled a new Web portal designed to teach users of confocal microscopy about Nikon products and advanced confocal techniques. The Nikon confocal Web portal ( offers new and experienced users a primer on confocal microscopy and highlights commonly used and advanced confocal techniques. The site contains detailed product guides to help users choose the right equipment for a particular application. It also contains links to instructional pages and interactive tutorials within Nikon’s Microscopy U Web site.

Nikon’s confocal site identifies spectral separation, sensitivity, and acquisition time as the most common challenges users face when working in confocal microscopy, and presents solutions to these issues based on Nikon’s extensive research, testing, and product designs.

“Unprecedented advancements in science and technology have led to an increased demand for more sophisticated and powerful microscopy products,” says Eric Flem, communications director of Nikon Instruments. “The confocal microscope is one of the most valuable tools in biomedical research. Our new Web portal provides researchers with the new resources to unlock the potential of this tool.”

Contact: Nikon Instruments (800) 52-NIKON;