Companies
Adeza Biomedical Corp
Antek HealthWare LLC
Audit MicroControls, Inc
bioMérieux
Ciphergen Biosystems Inc
David G. Rhoads Associates Inc
Genzyme Diagnostics
Millipore
Nanogen, Inc
Adeza
www.adeza.com
Company Profile
Adeza is a medical technology company located in Sunnyvale, California. Adeza’s focus is on proprietary tests and services for the diagnosis of pregnancy-related and female reproductive disorders including premature birth and infertility. In the U.S., preterm birth is the leading cause of perinatal mortality and morbidity with societal economic burden exceeding $26 billion annually.1
Product Profile
What is FullTerm, The Fetal Fibronectin Test?
Fetal fibronectin is an adhesive glycoprotein that is found at the maternal-fetal interface. Adeza’s proprietary FullTerm, The Fetal Fibronectin Test detects the presence of the fetal fibronectin protein and is used as an aid in the assessment of the risk of premature birth from 22 to 35 weeks of pregnancy. FullTerm, The Fetal Fibronectin Test has demonstrated effectiveness in 125+ published peer-reviewed studies and is available on Adeza’s TLiIQ® System.
Why Your Laboratory Should Offer FullTerm, The Fetal Fibronectin Test:
– Fetal fibronectin is the strongest independent predictor of preterm birth2
– ACOG recommended
– NIH studied
– Used in more than 80% of U.S. obstetric teaching hospitals
– Used in over 90% of major Level-3 Canadian birthing centers
Elevated amounts of fetal fibronectin should not normally be detected in the vagina after 22 weeks gestation. Disruption of the maternal-fetal interface causes the release of fibronectin into cervical/vaginal secretions. Fetal fibronectin appearance before the normal onset of labor is a strong indicator of preterm birth risk.
Managing Hospital Admission Costs
A cohort study was performed comparing the cost of preterm admissions when FullTerm,The Fetal Fibronectin Test was used routinely to the costs of the previous 12 months when it was not standard protocol.3 The use of the test decreased preterm labor admissions by over 50%.
Adeza TLiIQ® System
Adeza’s FullTerm, The Fetal Fibronectin Test is an in vitro diagnostic test that utilizes a single-use, disposable cassette analyzed on our TLiIQ System. This CE-marked and FDA-approved product is designed to aid in objectively determining a woman’s risk of preterm birth during pregnancy by detecting the presence of the fetal fibronectin protein.
Ease of Use
• Total hands-on time less than 60 seconds per test
• Walk-away operation: Patient result in 23 minutes
• Single-use dry chemistry cassette
• Easy to read QC and test results
Internal Quality Control
• Performed automatically with every patient test
• Verifies analyzer and cassette performance during patient testing
Daily Quality Control
Analyzer QC and System Verification with the QCette®
• Verification that the analyzer performance is within specification
• Reusable QC device with results in 3 minutes
• Simple to run with QC data stored in memory for easy reference
Additional Features
• Calibration code specific for each cassette lot
• Shelf life 18 months from date of manufacturing
Summary
• A negative (normal) fetal fibronectin test result provides peace of mind; <1% will deliver within the next 14 days
• A positive (elevated) fetal fibronectin test result allows interventions for those with highest risk of delivery in the next 14 days
• Fetal fibronectin testing offers your institution savings on unnecessary admissions for preterm labor
1. Behrman RE et al, Institute of Medicine, 2006
2. For women testing positive at 22-24 weeks and for preterm birth <32 weeks. (Goldenberg, 1998)
3. Joffe, GM et al. Impact of fetal fibronectin assay on admissions for preterm labor. Am J Obstet. Gynecol; March 1999:581-588.
Adeza
1240 Elko Drive, Sunnyvale, CA 94089
[email protected]
1 888.773.8376 (1 888 PRETERM)
Antek HealthWare
www.antekhealthware.com
Company Profile
Antek HealthWare, LLC, founded by Andy Pollack, has been in the business of providing innovative medical software solutions to the health care market since 1987. Everyday, more than 35,000 physicians depend on Antek to assist them with patient care.
Companies are started for numerous reasons and then refine their specific skill sets as opportunities arise in the form of unmet customer needs. Antek was approached by a physician group to build a custom laboratory information system (LIS), as the available systems were not addressing their needs. Management quickly realized that there was a nationwide need in physician office laboratories for a full featured LIS that was user-friendly. This was an incredible opportunity and LabDAQ was developed.
The LabDAQ Laboratory Information System was initially developed and released in 1991 as a DOS-based system. In late 1997, the first Windows based version was released. Over the years, Antek has continued to develop new features and options that provide the laboratory with the tools needed to respond to the demands they face every day.
Today, the LabDAQ system is the recognized market leader for laboratory information systems. LabDAQ has been installed in more than 1,800 laboratories, including hospitals, reference laboratories, physician office labs (POLs) and clinics of all sizes. The LIS software is easy to navigate, flexible in design, and dynamic in use. LabDAQ provides bi-directional interfaces to national and regional reference laboratories, as well as interfaces with other software systems within the hospital or physicians practice environment. This includes practice management systems, electronic medical record (EMR) and hospital information systems (HIS), which are driving overall connectivity opportunities within that market sector.
As an organization, Antek has built a reputation for innovation and responsiveness. The needs of the market continue to be evaluated, which provides the basis for enhanced solutions for LabDAQ clients, both in product features and new options. A prime example is the release of DAQbilling, Practice Management System in 2001.
LabDAQ clients were looking for a low-cost solution for medical billing. DAQbilling provides a quick, easy way to schedule patients, file claims, and manage accounts receivables, while increasing efficiency and profitability. DAQbilling is a subscription service so there are low start-up costs, no technical support fees, and no upgrade fees.
Headquartered in Reisterstown, MD, Antek employs more than 80 professionals, including software programmers, hardware and network specialists, and laboratory and billing experts. Regional sales offices are located in Maryland, Florida, Texas, Illinois, Kansas, Ohio, Missouri, and California. Antek also works with many national and regional distributors across the country.
The Technical Support department has a best in class reputation for being available and responsive to the needs of LabDAQ users. Technical support engineers answer 97% of all calls. Clients aren’t forwarded to a voice messaging system. The customer-focused dedication of the team, combined with superior medical software products, has resulted in outstanding customer loyalty and a reputation for excellence.
Antek is fully committed to delivering the best product and the best technical support possible. The mission statement says it perfectly, “Antek is dedicated to the development of advanced software solutions designed to facilitate the practice of medicine. By understanding the needs of our customers and the markets we serve, we strive to offer intuitive solutions that exceed expectations with quality products and superior after sales support.”
Product Profile
LabDAQ
LabDAQ was designed with the flexibility and features to meet the needs of many types of facilities- POLs, clinics, reference labs, and small hospitals. System configuration and scalability enable each lab to define the system to meet their specific needs. LabDAQ is flexible so that as your lab grows, LabDAQ can also be expanded.
Ease of use and workflow management are hallmarks of LabDAQ, along with innovation and continued improvement. The software supports true multi-tasking. Open windows are managed from a unique vertical task bar, which addresses the issue of screen clutter. Only the window currently in use is displayed; all other windows are available with a simple click. Antek constantly evaluates the needs of the market to develop solutions for its customers, both in product features and new options. These options include the ability to export control results to external QC programs, e-mail delivery of results to physicians and insurance filtering.
LabDAQ is designed to help laboratories effectively manage data and resources. Key features include a comprehensive quality control module, medical necessity, and security tools. LabDAQ also offers consolidated and cumulative patient reports, as well as sophisticated management reports. LabDAQ enhances productivity and can improve both laboratory efficiency and profitability.
HL7 interfaces with other systems (HIS, EMR, etc.) and reference labs represent a growing need in the clinical laboratory. Antek provides interfaces to new systems and reference labs on a regular basis. Antek takes the lead in working with other vendors to ensure that the interfaces are completed in a timely manner.
Total Integration…Reliable Operation…Superior Service…Experience the Power of LabDAQ.
“This is a very good LIS system that has excellent features and robust functionality. The system is easy for our end users to work with, and they are quite productive with it.”
-KLAS, 2006 Comprehensive LIS Study
LabDAQ+
Introducing LabDAQ+…The years of experience working in collaboration with our clients led Antek to create this innovative new product. LabDAQ+ is built upon Antek’s solid foundation in laboratory software and offers novel features that address the needs of the laboratory, administration, and IT departments alike.
Working with clinic and hospital clients, Antek determined that the needs of today’s LIS extend well beyond the laboratory environment. In response, new features have been created that will dramatically reduce the administrative chore of running the daily lab operation and assist with IT functions. An early warning system, specifically designed for the IT department, uses Simple Network Management Protocol (SNMP) that integrates with clients’ existing networks. A lab scheduling tool, internal lab-mail, and tasks lists are just a few of the new additions.
LabDAQ+ was designed with powerful tools that will redefine administration of the laboratory and will show laboratory information in a new light. These innovative functions present a dashboard view of real-time performance data that will help you better manage specific tasks and resources. This full-featured system includes a robust microbiology module, a comprehensive management review module, and an intuitive & detailed insurance filtering module. True bi-directional interfaces with regional & national reference laboratories, as well as HL7 interfaces to a host of EMRs and practice management systems are also included.
The end result is a breakthrough new product….LabDAQ+.
Antek HealthWare, LLC
228 Business Center Drive
Reisterstown, MD 21136
800-359-0911
[email protected]
AUDIT Microcontrols, Inc.
www.auditmicro.com
Company Profile
Founded in 2002, AUDIT MicroControls is a wholly owned subsidiary of Aalto Scientific, Ltd. of Carlsbad, CA. Specializing in calibration verification/linearity products, and routine and esoteric chemistry quality controls, the goal of AUDIT is quite simple – to make superior products at competitive prices. And over the past four years this has been accomplished by avoiding overdevelopment of its product lines. Failure is usually a certainty if you try to be everything to everyone. AUDIT’s products are the “race cars” of the clinical diagnostics quality control industry – they do what they are designed to do and they do it extremely well. No fluff, no unnecessary features, no multiple analytes that the customer does not need, just high performance products.
AUDIT also prides itself on being a customer-oriented, customer-driven sales and marketing organization. The need for a rapid customer service/technical service response is not unique only to the clinical diagnostics industry. Other industries suffer with the lack of a timely response to their customers when the need arises. AUDIT provides stellar customer service and technical support through its Customer Support Center in Carlsbad, CA, its Distribution Center in Las Vegas, NV, and its Regional Sales Managers located across the country. AUDIT products are available through a number of regional and national distributors, making it that much easier for their customers to purchase all or some of the many available products.
With Research and Development located in Carlsbad, CA, the various product lines continue to be developed and improved upon in response to the needs of AUDIT’s customers. These include MicroCV™, a line of products designed to assist non-waived laboratories in satisfying the CLIA-88 requirements for calibration verification/linearity, MicroFD™ and MicroLQ™, routine and specialty chemistry and immunoassay freeze-dried and liquid quality control products, and the newest addition to the family of quality control products – MicroDROP™, a urine dipstick quality control product. AUDIT boasts the only BNP control available for both BNP-32 and NT-proBNP in one vial, as well as several products from the MicroCV calibration verification/linearity product line that are not available from any other manufacturer in the world. AUDIT has some exciting new products on the horizon that involve innovative packaging and product delivery systems that will save both time and money for their customers. These are due to be released in 2007.
As AUDIT continues to improve its existing products and add new quality control and calibration verification/linearity products, it remains determined not to lose sight of who made them what they are today – their customers. While some companies experience huge growth spurts through increased sales or acquisitions of its competitors, AUDIT maintains a small company philosophy – to be flexible and quick to respond, to treat each customer individually, to stay determined, and to never lose sight of the ultimate goal – success!
Product Profile
AUDIT® MicroControls’ MicroCV™
AUDIT® MicroControls’ MicroCV™ Calibration Verification/Linearity product line has been designed to assist the non-waived laboratory in satisfying the CLIA-88 requirements for calibration verification/linearity. Recently adopted CLIA-88 regulations state that each laboratory revalidate each of its test method’s analytical measurement range (AMR) at least every six months as well as following changes in lots of analytically critical reagents or major system components. AUDIT offers a product with five unique levels of linearity material to allow for complete monitoring of that specific test system’s reportable range, as defined by the manufacturer. Products offered include the popular General Chemistry Linearity Set that includes 30 different routine chemistry analytes in one vial, the only products available anywhere for both BNP-32 and NT-proBNP, eighteen different Immunoassay analytes, D-Dimer, Tumor Markers, RF/CRP and ASO.
In addition, the AUDITOR™ QC Program assists the laboratory with the reduction of calibration verification data. Accessible via www.auditmicro.com, one simply enters the raw data and AUDITOR instantly provides an on-line graph that can be easily printed and stored. It also allows the user to compare his or her results with those users with the same instrument, using the same lot of calibration verification material.
AUDIT® MicroControls’ MicroFD™ BNP Control
AUDIT® MicroControls’ MicroFD™ BNP Control is the only commercially available control that can be used with all BNP-32 and NT-proBNP assays. MicroFD™ BNP Control is assayed with values for the Abbott AxSYM®, Bayer ADVIA Centaur® and ACS:180®, Beckman Access®, Access® 2, SYNCHRON Lx®I 725 and UniCel® Dxl 800, Biosite® Triage®, Dade Dimension® RxL Max™ and Xpand™, and Roche Elecsys®.
Available in two sizes, a 0.5mL and a 1.0mL plastic vial, this freeze dried quality control is stable for two years unopened at 2-8°C. Open vial stability, once reconstituted, is 8 hours (for BNP-32 assays) or 5 days (NT-proBNP assays), depending on which assay is being monitored.
In addition, the AUDITOR™ QC Program assists the laboratory with the reduction of quality control data. Accessible via www.auditmicro.com, one simply enters the raw data and AUDITOR instantly provides an on-line graph that can be easily printed and stored. It also allows the user to compare his or her results with those users with the same instrument, using the same lot of quality control material.
AUDIT® MicroControls’ MicroFD™ Glycohemoglobin A1c Control
AUDIT® MicroControls’ MicroFD™ Glycohemoglobin A1c Control is assayed for the Tosoh 2.2 and G7, Bio-Rad VARIANT™, Roche INTEGRA, and Dade-Behring Dimension® RxL.
Available as a freeze-dried bi-level control, each set comes with four 0.5mL vials of each level, for a total of eight vials per set. This quality control material is stable for two years from the date of manufacture unopened at 2-8°C. Open vial stability, once reconstituted, is 7 days.
In addition, the AUDITOR™ QC Program assists the laboratory with the reduction of quality control data. Accessible via www.auditmicro.com, one simply enters the raw data and AUDITOR instantly provides an on-line graph that can be easily printed and stored. It also allows the user to compare his or her results with those users with the same instrument, using the same lot of quality control material.
AUDIT MicroControls, Inc
3540 West Sahara Avenue, #086
Las Vegas, NV 89102
Tel: (866) 252-8348
Fax: (769) 431-6942
bioMerieux
www.biomerieux-usa.com
Company Profile
bioMérieux continues its fight against drug-resistant organisms and the inappropriate use of antibiotics
In an effort to combat emerging disease threats, bioMérieux recently launched an innovative system to collect organisms exhibiting unusual antimicrobial resistance mechanisms. The bioMérieux Organism Resistance Initiative Surveillance (BORIS) network addresses gaps in data through the proactive collection of bacterial isolates. bioMérieux will work with six U.S. clinical laboratories to collect the isolates, which will aid in internal research and product development.
Microorganisms exhibiting unusual patterns of antimicrobial resistance pose an enormous challenge to clinical laboratories with respect to accurate detection, treatment recommendations, and associated hospital costs. Public health professionals have struggled with the issues of methicillin-resistant S. aureus (MRSA) and the possible effects of a bird flu epidemic. An active bacterial surveillance program can help identify specific pathogens and resistance mechanisms, which is the first step to improving diagnostic methods and early initiation of interventions.
The Infectious Disease Society of America (IDSA) recently released a list of six “super bugs,” defined as “drug-resistant organisms constituting a public health threat, but having few or no drugs available for treatment.” The diagnostic industry plays an essential role in the fight against the spread of resistant organisms and must contribute to detection of antimicrobial resistance by continued development of rapid, accurate methods of microorganism detection and characterization.
As an industry leader in the field of diagnostic microbiology, bioMérieux acknowledges its responsibility to conduct research in the fields of bacterial pathogenesis and antimicrobial resistance mechanisms. The establishment and long-term support of BORIS will ultimately result in increased knowledge for all microbiologists, better products, better customer service, and ultimately, better patient care.
In addition to launching the BORIS system, bioMérieux recently established an agreement with the Alliance for the Prudent Use of Antibiotics (APUA®), a non-profit, international organization dedicated to promoting appropriate antibiotic access and use in an effort to curb antibiotic resistance worldwide. bioMérieux donated an education grant to support APUA in an independent research and educational project entitled, “Measuring the Economic Burden of Drug Resistance in the U.S.”
bioMérieux is committed to promoting responsible antibiotic use, as it directly impacts good patient care. This issue is even more critical today given the numerous pilot programs that link reimbursement and quality measures, such as programs like Pay for Performance. One of the project goals is to evaluate the cost-effectiveness of various interventions to detect and manage the emergence of antibiotic resistance, including appropriate diagnostics.
In addition to bioMérieux’s efforts to fight emerging resistance and support the prudent use of antibiotics, the company devotes a large portion of its annual budget to research & development. Some of these products are highlighted on the next page and contribute greatly to automating the lab and improving patient care. bioMérieux is dedicated to getting the right information to the right person, at the right time to empower better therapeutic decisions.
Sincerely,
Herb Steward
Senior Vice President, North American Commercial Operations
Product Profile
VITEK® 2 for Rapid ID/AST Testing
VITEK® 2 and VITEK® 2 Compact are automated bacterial identification and antibiotic susceptibility testing systems (ID/AST) designed to provide same-day results. The VITEK 2 platform detects changes in organism growth under various media and antibiotic concentrations and works with an Advanced Expert System that interprets the antibiotic resistance patterns and reports the resistance phenotype useful to patient treatment and infection control. The system offers rapid results, providing increased productivity and improved workflow.
VITEK 2’s Data Management systems allow the user to generate both statistical and list reports. The variety of selecting and sorting parameters (40+ fields) allows for reports to contain user specific data, thus zeroing in on specific epidemiological situations. List reports can be generated for specific locations (i.e. ICU, NICU), specific organism/antibiotic combinations (i.e. Acinetobacter spp., MRSA, VRE) and more complex searches (i.e. Blood Cultures, Inpatients, Pseudomonas aeruginosa resistant to Amikacin). Statistical reports also have the same selection and sorting parameters and may be generated for a specific time period or trended by month.
STELLARA™ Patient Therapy Management Software
bioMérieux recently announced the one-year anniversary for STELLARA™ Clinical Intervention and Patient Monitoring software, powered by TheraDoc® Expert System Platform®. The STELLARA system provides knowledge-enriched, infectious disease-specific recommendations to clinicians for medication treatment management.
A six-month study completed at Franciscan Health System (FHS) in Tacoma, Washington demonstrates impressive results. Cost savings from interventions increased by 23 percent and FHS pharmacists prevented 222 adverse drug events (a 23 percent increase from 2004) after implementation of STELLARA. In addition, FHS pharmacists efficiently managed a 41 percent increase in medication orders without forfeiting quality or adding staff.
STELLARA software integrates pharmacy and lab data, including microbiology results (identification, susceptibility and resistance) from bioMérieux’s BacT/ALERT® blood culture system and VITEK 2 directly to the pharmacist and clinician to allow for quicker and more accurate treatment decisions for the patient.
NucliSENS® Molecular Diagnostic Products for Respiratory Pathogens
bioMérieux recently launched two new analyte specific reagents (ASRs) for Mycoplasma pneumoniae and Chlamydia pneumoniae. Each NucliSENS® Primer/Probe Mix is designed for individual pathogen 16S ribosomal RNA amplification and real-time detection using bioMérieux’s proprietary Nucleic Acid Sequence-based Amplification (NASBA®) combined with molecular beacon technology.
CLIA high-complexity laboratories can incorporate these quality analyte specific reagents into in-house developed molecular-based tests for these important atypical bacterial pneumonia pathogens. Culture of these organisms is extremely difficult and physician knowledge of their presence is important to making appropriate antibiotic therapy decisions since both are naturally resistant to penicillins and cephalosporins. Early use of adequate antimicrobial agents will reduce the risk of more complicated courses of respiratory infection that have been associated with these distinctive bacteria.
Other NucliSENS real-time ASRs available from bioMérieux include those for Human Metapneumovirus (hMPV) and Respiratory Syncytial Virus (RSV).
Please visit the bioMérieux booth at ICAAC (booth # 1516).
bioMérieux, Inc.
bioMérieux
100 Rodolphe Street
Durham, NC 27712
800-682-2666
www.biomerieux-usa.com
Ciphergen
www.ciphergen.com
Company Profile
Ciphergen’s mission is to discover, develop, and commercialize high-value protein-based diagnostic products and tools
Ciphergen is a leading provider of enabling tools and collaborative services in the field of protein-based biology research, known as proteomics. Scientists involved in proteomic research seek to understand the role of proteins in the biology of disease, such as monitoring disease progression and evaluating the therapeutic and side effects of drugs.
Technology Solutions
Ciphergen develops, manufactures and markets ProteinChip® technology solutions (systems, software, and consumables) for clinical and drug development research. The ProteinChip System Series 4000, launched in 2004, was built with superior biomarker sensitivity, resolving power, and quantitation capabilities, enabling biomarker discovery, purification, identification, and quantitative assays at the benchtop. Ciphergen’s unique biomarker discovery process is called The Pattern Track™ Process that integrates its proprietary ProteinChip Arrays and surface enhanced laser desorption/ionization time of flight mass spectrometry (SELDI-TOF-MS) with Biomarker Patterns™ and Ciphergen Express™ Software to allow the scientist to seamlessly analyze large amounts of proteomic data. The ProteinChip Arrays contain chemically or biochemically treated surfaces for specific interaction with proteins of interest. This protein mass profile, or retentate map, of the proteins bound to each of the ProteinChip by the ProteinChip Reader allows rapid protein discovery.
Biomarker Discovery Center® Facilities
Recently, Ciphergen has expanded the proteomic collaborative research services available through its Biomarker Discovery Center® facilities. This service allows clients and collaborators to leverage Ciphergen’s internal scientific expertise and emerging technology solutions to answer their clinical questions efficiently and effectively. Ciphergen has biomarker experience in the disease fields of oncology, neurology, cardiovascular and infectious disease for target discovery and validation, disease monitoring (drug efficacy, progression, and recurrence), toxicology and drug safety, and patient stratification.
The partnership programs provide:
• Access to proven expertise in customized study design and biostatistical analysis
• State-of-the-art SELDI platform protocols
• Equalizer™ Beads and Multi-Select Fractionation to discover low abundance proteins
• Experience with diverse sample types, including serum/plasma, urine, CSF, cell lysates, lavage, laser capture microdissected cells, etc.
• Assay or prototype assay development capabilities
Diagnostic Development
Ciphergen is leading the development of new, high-value, protein-based diagnostic tests through its strategic alliance with Quest Diagnostics. In July 2005, Quest Diagnostics Incorporated, the leading provider of diagnostic testing, information and services in the U.S., announced the formation of a strategic alliance to develop and commercialize novel proteomic diagnostic tests based on Ciphergen’s proprietary SELDI ProteinChip® technology. Over the next three years, the strategic alliance will focus on the commercialization of selected assays chosen from Ciphergen’s pipeline. Together, Ciphergen and Quest have the opportunity to translate biomarker discovery into clinical diagnostic tests that will address unmet medical needs.
Product Profile
ProteinChip System, Series 4000
The ProteinChip System, Series 4000 instrumentation is a flexible system delivering superior performance while offering the fastest route to biomarker discoveries. Depending on your need for throughput, Ciphergen offers two versions of instruments:
The ProteinChip System, Series 4000 Personal Edition, designed with the biology laboratory in mind, delivers affordable, benchtop biomarkers research for academic and industrial laboratories. The Personal Edition offers complete biomarker discovery, characterization and assay development in low-to-medium throughput labs.
The ProteinChip System, Series 4000 Enterprise Edition is a fully automated system for biomarker discovery and assay in large-scale studies. The Enterprise Edition is designed for high throughput biomarker analysis research. Thousands of samples can be analyzed unattended, using ProteinChip Arrays, each with a barcode for automated data tracking.
The Series 4000 system delivers:
• Superior quantitation
• Enhanced sensitivity
• Increased resolving power
• Expanded throughput
• Improved reproducibility
• Powerful bioinformatics tools
• Maximized dynamic range
Arrays, Consumables, and Software
Ciphergen supplies a wide range of ProteinChip Arrays, associated consumables and software to be used with the ProteinChip System:
ProteinChip Arrays provide researchers with a choice of surfaces either chemically treated or pre-activated for user defined affinity applications.
ProteinChip Kits are available for the most popular ProteinChip applications. In addition to the appropriate arrays, these kits contain buffers, controls, and detailed protocols for use.
Ciphergen’s Bioprocessor products allow handling of larger sample volumes in formats compatible with liquid handling equipment, for increased convenience and throughput.
Additional Accessories are available to complement the use of the ProteinChip Arrays. Ciphergen supplies a number of reagents, including protein and peptide standards, Energy Absorbing Molecules (EAMs), and spin columns for preparation of samples prior to analysis.
CiphergenExpress™ Biomarker Analysis System Software helps manage the complex sample tracking and data flood inherent to biomarker discovery. Flexible application modules provide powerful, advanced data mining and analysis capabilities for rapid, automated analysis of multiple experiments over multiple conditions to identify potential biomarkers.
Biomarker Patterns™ Software (BPS) is a unique, Windows-based package for supervised classification of SELDI mass spectral data sets derived from the Ciphergen ProteinChip platform. BPS capabilities feature an automatic and rapid location of biomarker patterns in SELDI data sets, multiple biomarker correlation with phenotype in clinical research studies, and hierarchical view of specific proteins correlated with phenotypes (identifying and ranking the potential importance of individual biomarkers).
Ciphergen products are for research use only. Copyright © 2006 Ciphergen Biosystems, Inc. All rights reserved.Ciphergen, ProteinChip, and Biomarker Discovery Center are registered trademarks of Ciphergen Biosystems,Inc.
Ciphergen Biosystems, Inc.
6611 Dumbarton Circle
Fremont, California 94555
888-864-3770
David G. Rhoads Associates, Inc.
www.dgrhoads.com
Company Profile
Developing Software for the Quality-Driven Clinical Laboratory Since 1983
David G. Rhoads Associates, Inc., incorporated in 1983, is deeply involved with the science and technology of the clinical laboratory.
Rhoads’ president, David G. Rhoads, has had 9 years of experience as a hospital based clinical chemist. He has a Ph.D. in Biochemistry from Brandeis University, is Board Certified in Clinical Chemistry (DABCC) and has been a member of the AACC since 1975. He is very concerned with the quality of the work coming from clinical laboratories.
David Rhoads feels strongly that the concept of quality in the clinical laboratory is far more complex than just passing proficiency testing surveys and assaying quality control specimens. It includes a thoughtful approach to selection of reliable tests with adequate analytical properties, a commitment to a quality workforce, use of reliable reference intervals, and establishment of performance standards appropriate to each test. Most of all, it requires a commitment to quality which starts with each organization’s leadership. While you cannot buy a computer program which provides organizational leadership, you can buy a computer program which will analyze the results statistically and tell you how well your tests are performing.
EP Evaluator™ is such a computer program which, in fact, evaluates and validates clinical laboratory tests. This program is widely accepted throughout the United States and Canada. It is used in a large number of hospitals and reference laboratories. Major vendors have adopted it for use in their R & D labs or as part of the installation services they provide to their customers or both.
In the 15 years since EP Evaluator was first marketed, it has grown from 5 to 23 modules. While most (21) of those modules are statistical in nature, two are for lab management. The statistical modules deal with all the method validation and evaluation requirements as specified by CLIA ’88, College of American Pathologists and the other regulatory organizations.
One of the strengths of EP Evaluator is that in several key modules, it provides pass/fail results. This will give you a definitive statement as to whether the test passes or not. Many of Rhoads’ customers love the program because of this assurance that their tests are working properly. Witness two comments from Rhoads’ customers:
EP Evaluator is a powerful and indispensable tool in my daily practice of clinical laboratory medicine. Since I began using the initial release of this software in 1991, it has been steadily improved and useful new modules have been added with every revision.
Salvador F. Sena, Ph.D., DABCC, Director, Clinical Chemistry, Danbury Hospital, Danbury, CT.
We trust EP Evaluator to provide us with reliable assessments of the performances of our many instruments.
Pushpa Ramachandran, BS, CLS, Assistant Laboratory Manager, Special Chemistry and Toxicology, Kaiser Permanente Regional Reference Laboratory, North Hollywood, CA.
EP Evaluator incorporates copyrighted Standards and Guidelines of the Clinical and Laboratory Standards Institute.
Product Profile
EP Evaluator™
EP Evaluator, Release 7 is designed specifically for the clinical lab so the user can meet all CLIA ’88 and CAP requirements for validating and evaluating methods. The standard version includes both statistical and lab management modules. The program is flexible, easy to install and use, and provides professional reports which are well-designed and easy to understand.
Statistical Modules for Quality Assurance
The statistical modules are designed to deal not only with the initial validation or evaluation of instrument methods, but also with the semi-annual CLIA ’88 requirements of calibration verification and demonstration of instrument harmonization. The 21 statistical modules of the Standard version are grouped as follows: Linearity (1 module), Precision (2 modules), Method Comparison (7 modules), Reference Intervals (3 modules), Sensitivity (2 modules) and Other (6 modules).
One special feature of EP Evaluator is that many of the statistical modules provide pass/fail answers based on performance standards established specifically for the instrument method involved. This feature makes it easy to determine whether or not a particular method is operating correctly.
Lab Management Modules Address Two Critical Issues
The two lab management modules deal with two critical issues for running the lab: costs (Cost Per Test) and patient safety (Incident Tracking). EP Evaluator gives the major advantage of providing a consistent, standardized approach to the calculation process where all the cost elements are included. The Incident Tracking module counts and analyzes various lab incidents or errors so quality improvement measures may be taken with respect to Patient Safety.
Flexibility and Productivity
EP Evaluator comes in several different versions to fit the needs of many types of labs—large, medium or small. Productivity can be enhanced by the several approaches for entering data rapidly and accurately. These include capture of data from spreadsheets, directly from instruments and of course, manual data entry. Furthermore, data from EP Evaluator can also be exported to spreadsheets.
Another special productivity feature in EP Evaluator is the capability to define Policies, which include items like test names, units, and reportable ranges. These data make the results meaningful. Once Policies are defined, they allow standardization for the whole system.
Training Workshops
Workshops are scheduled on a regular basis throughout the United States and Canada to help people understand EP Evaluator and its underlying concepts.
Each Spring and Fall, the Basic workshop entitled Design and Interpretation of Method Evaluation Experiments Using EP Evaluator is scheduled in various regions throughout North America. Topics covered in this one-day workshop include:
• Basics of using EP Evaluator
• How to define Performance Standards
• Design and Interpretation of Linearity Experiments
• Design and Interpretation of Method Comparison Experiments
At least one Advanced workshop per year is scheduled in the Spring. This two-day workshop covers many aspects of EP Evaluator which are not covered in the Basic workshop such as the remaining modules, Rapid Results Entry and Policy Definitions.
For more information visit www.dgrhoads.com
David G. Rhoads Associates, Inc.
504 Meetinghouse Lane
Kennett Square, PA 19348
(800) 786-2622 (US and Canada), (610) 388-2608 (fax)
www.dgrhoads.com
Genzyme Diagnostics
www.genzymediagnostics.com
Company Profile
Genzyme is one of the world’s leading biotechnology companies. With more than 8,500 employees throughout the world, we are united by a common goal: to make a major positive impact on the lives of people with debilitating diseases.
This year marks the 25th anniversary of Genzyme’s founding. Since 1981, the company has grown from a small start-up to a diversified enterprise. Over the past two decades we have introduced a number of breakthrough treatments in several areas of medicine, which have provided hope to patients who previously had no viable treatment options. Today our products are helping patients in more than 80 countries.
Research and Development
Our research and development efforts are focused on the areas of medicine where we market commercial products. We also conduct research in cardiovascular disease and other areas of unmet medical needs.
When we identify unmet medical needs, our large team of scientists and researchers uses a broad range of scientific approaches and technologies to meet those needs. We are a leader in novel areas such as cell and gene therapies and biomaterials and we also partner with other companies to develop new products and support research conducted by top academic and independent medical science centers.
Focus
Today, we continue to be driven by our commitment to patients. We are working to develop new medicines, improve existing therapies, secure approvals for products around the world, and ensure that patients have access to these treatments.
Genzyme focuses on six broad areas of medicine:
• Lysosomal Storage Disorders
• Renal Disease
• Orthopaedics
• Transplant and Immune Diseases
• Oncology
• Genetics
• Diagnostics
Genzyme Diagnostics
Genzyme Diagnostics is a major supplier of diagnostic products, with a focus on infectious diseases, women’s health, diabetes and cardiovascular disease. We play an important role in the movement toward personalized medicine by developing tests that can help physicians identify how patients are likely to respond to targeted therapies.
Our mission is to establish and sustain a position as a leading supplier of quality, niche products to key segments of the worldwide in vitro diagnostics market. Simultaneous with our focus on growth is our equally important commitment to customer satisfaction.
The OSOM® line of rapid tests offers physicians high quality diagnostics in the infectious disease and women’s health markets for the detection of Strep, Flu, Mono, Trichomonas, Bacterial Vaginosis and Pregnancy.
OSOM® Ultra Strep A Test
OSOM® Influenza A&B Test
OSOM® Mono Test
OSOM® Trichomonas Rapid Test
OSOM® BVBLUE Test
OSOM® hCG Urine and Card Pregnancy Tests
OSOM® hCG Urine Combo Test
For more information or to contact a Genzyme Diagnostics Territory Manager, call us at 800-332-1042 or visit us online at genzymediagnostics.com
Product Profile
With Fall and Winter Comes Flu and Strep Be Ready To Test
The seasons bring more than a change in the weather: they bring flu and strep. Genzyme Diagnostics brings you OSOM® Influenza A&B and OSOM® Ultra Strep A rapid tests. Objective, easy- to-use, with accurate results in minutes, both tests help you determine the appropriate treatment and can minimize the use of antibiotics.
OSOM® Influenza A&B TestNEW!
Flu season, typically October through May, comes down hard with over 200,000 Americans hospitalized each year. The OSOM® Influenza A&B Test is a comprehensive panel which differentiates between flu A and B with results in 10 minutes, and less than one minute hands-on time. Backed by an experienced team of medical technologists to provide support, you can be confident that OSOM delivers the highest quality.
• Accurate, differential diagnosis
• Differentiates between influenza A & B.
• Three distinct lines.
• Nasal swab specimens
• Capable of detecting some animal and avian influenza strains.*
• Room Temperature Storage
• Includes 2 extra test sticks for external QC testing.
*Although this test has been shown to detect cultured avian influenza viruses, including avian influenza A subtype H5N1 virus, the performance characteristics of this test with specimens from humans infected with H5N1 or other avian influenza viruses are unknown. See package insert for details.
OSOM® Ultra Strep A Test
Studies have shown that the sensitivity of the OSOM® Ultra Strep A Test and the standard single swab culture method are not statistically different.*
• Fast
• Results in 5 minutes
• Easy to read
• Two-color results
• Convenient
• 25 test kit (single reagent delivery system)
• 50 tests (dual reagent delivery system)
• Includes positive and negative controls
• Room temperature storage
*See package insert for study results
Genzyme Diagnostics
One Kendall Square
Cambridge, MA 02139
(800) 332-1042
Direct: 617-252-7760
Email: [email protected]
Millipore
[removed]www.millipore.com/chemicon[/removed]
Company Profile
CHEMICON is now part of Millipore. Diagnostic detection products constitute an important and expanding area of focus for Millipore, providing quality products and services to advance science within the research, diagnostic, and pharmaceutical communities. Our Antibody-based detection systems and reagents are available for Respiratory viruses, Enteroviruses, Herpes Viruses, Rabies, Measles, Mumps, P. carinii, and T. vaginalis, and an array of common serology test kits including, Measles, Amebiasis, and Dengue. CHEMICON supplies a broad selection of proven, top-quality, and consistent diagnostic test reagents for clinical and health organizations worldwide. At CHEMICON we strive to provide the best reproducibility and affordability in every diagnostic product that we supply.
Timeline:
2006: Chemicon becomes a part of Millipore.
2005: Chemicon focuses on expanding its diagnostics product line.
2004: Serologicals acquires Upstate Group, Inc. positioning Serologicals as a major partner to customers performing drug research, discovery and development.
2003: Chemicon received the Certificate of Registration for the ISO 13485 quality standard and the approval to use the CE marking per EC Directive 98/79/EC Annex IV, Article 3.
2002: Chemicon introduces a new Post-Amplification detection analyte specific reagent*, the Light Diagnostics™ OligoDetect® West Nile reagent (Cat No 3045). The first of many OligoDetect® reagents.
1999: Chemicon launches new Light Diagnostics™ Trichomonas vaginalis DFA kit (Cat No 3196) for the qualitative detection and identification of Trichomonas spp. in patient specimens.
1998: Chemicon launches new Light Diagnostics™ Rabies DFA Reagent (Cat No 5100) & the Light Diagnostics™ SimulFluor® Flu A / Flu B kit (Cat No. 3121) receives IVD 510(k) approval.
1996: Chemicon launches first DFA reagent Light Diagnostics™ CMV DFA Kit (Cat No 3245).
1995: Chemicon develops first IVD reagents for detection of Enteroviruses – The Light Diagnostics™ Enterovirus Screening Set (Cat No 3365).
1994: Chemicon launches the Light Diagnostics™ CMV IFA (Cat No 3135).
1993: Chemicon receives its first IVD 510(k) approval for the Light Diagnostics™ Respiratory Panel 1 Viral Screening and Identification IFA Kit and reagents (Cat No 3105).
1990: Chemicon receives IVD 510(k) approval of Light Diagnostics™ Measles IFA kit (Cat No 3187).
1985: Chemicon offers disease-state serum and introduces a number of drug related antibodies.
1981: Chemicon International Inc. begins supplying immunological reagents to the biomedical research community.
*Analyte specific reagents are products for which the analytical and performance characteristics have not yet been established and can only be used by high-complexity labs, including those regulated by CLIA, public health labs, VA hospitals and other diagnostic manufacturers.
Product Profile
Amplifluor®
The patented real-time Amplifluor® fluorescent d
