NEW TECHNOLOGIES
The underlying theme in the IVD industry during the past couple of years has been consolidation. For example, building on its previous acquisitions of Diagnostic Products Corp. and Bayer Diagnostics, Siemens Healthcare Diagnostics (Deerfield, IL) also purchased Dade Behring Inc. for $7 billion. With this acquisition, Siemens solidified its position as one of the biggest IVD companies in the world.
Another traditional diagnostic imaging company, General Electric Co. (Fairfield, CT), had also attempted to buy the primary IVD and point-of-care diagnostics businesses of Abbott Diagnostics (Abbott Park, IL) for $8.13 billion. However, the two companies were unable to agree on final terms and conditions of the proposed sale, and mutually agreed to terminate their merger agreement.
Beckman Coulter Inc. (Fullerton, CA) had lost a bid to acquire Biosite Inc. to Inverness Medical Innovations Inc. (Waltham, MA). Inverness has continued to build on this purchase by acquiring such companies as Panbio Ltd., Alere Medical Inc., and Cholestech Corp. Meanwhile, Roche Holding AG (Basel, Switzerland) finally closed its deal to buy Ventana Medical Systems Inc. for $3.4 billion.
It may still be a while before the fallout from such consolidation takes full effect on the IVD industry. For now, IVD manufacturers have continued to develop and release faster, more accurate, and more effective diagnostic devices. This article examines some of the key segments of the IVD industry, highlighting trends and new product launches in each area.
Instrumentation and Automation
During the past few years, a number of trends in laboratory medicine have affected the development and implementation of automation in lab analyzers. Such trends are related to reducing costs, running tests with fewer lab personnel, and maintaining quick turnaround times for test results. IVD manufacturers have been responding to such trends in automation and instrumentation in different ways.
One trend is automating the preanalytical sample preparation steps, including registering samples in the laboratory information system, centrifuging blood tubes, and preparing them to be sampled. Seeing this trend, several major IVD manufacturers have developed and offer automated sample prep systems.
As the postgenomic era continues to unfold, another trend is the increasing number of samples arriving in laboratories for molecular analysis. Such increases place added demands on automated instruments that can handle the specialized needs of molecular tests. For example, lab automation will need to be able to conduct closed-tube sampling for DNA analysis in order to minimize the increased risk of cross-contamination.
The intense consolidation among IVD manufacturers, commoditization of most chemistry offerings, and increasing price pressures have pushed the cost per test of routine chemistries to low levels. The average 1-2% annual growth in this segment derives from new tests in the area of lipid analysis, proteins, hormones and enzymes related to research in diabetes, cardiovascular disease, cancer, and other acute and chronic conditions.
In addition, with so much of a lab’s workload concentrated on a few analyzers, any downtime due to instrument malfunctions is disastrous. In the past few years, remote instrument analysis via device relationship management (DRM) has become an integral part of instrument quality control. DRM is software that enables interactive monitoring and servicing of lab instruments through the Internet. It also allows IVD manufacturers to run routine instrument maintenance and inspection activities from a remote location.
Abbott Diagnostics introduced the Architect i1000SR immunochemistry analyzer, expanding its Architect family of diagnostic instrument systems for clinical laboratories. Designed for labs that typically perform fewer than 200 immunoassay tests per day, the instrument addresses many of the workflow challenges common in today’s laboratories. By providing continuous access to reagents and samples while the instrument is running, the Architect i1000SR enhances laboratory productivity.
Abbott also previewed an upcoming addition to the Cell-Dyn family of hematology instruments, the Emerald, at the American Association of Clinical Chemistry Annual Meeting. The system is designed to be a valuable tool for performing complete blood counts (CBCs). The system has the ability to complete CBC results in 60 seconds and report results in easy-to-read histograms representing white blood cells, red blood cells, and platelets. Expected to be available in the United States by the end of the year, the system will expand Abbott’s hematology platform by offering a premium, robust low-volume solution for small to mid-sized clinical laboratories.
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The BD Bactec FX Blood Culture System by BD Diagnostics (Sparks, MD).
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BD Diagnostics (Sparks, MD) launched the BD Bactec Fx Blood Culture System for the detection of bloodstream infections. The system enables remote observation of blood culture data from outside the microbiology department through integration with the BD EpiCenter Microbiology Data Management System. This capability allows clinician access to laboratory results during any shift, and provides a visible and audible alarm on the remote BD EpiCenter client or on an existing computer monitor in a more highly occupied area of the lab.
bioMérieux (Marcy l’Etoile, France) unveiled three new microbiology laboratory automation platforms. These platforms include the following: the Previ Isola, a prepoured media streaker designed to automate routine agar plate processing, the Previ Color Gram, bringing automation to a new lab procedure with its staining technology, and the UF-1000i, a urinary screening tool that allows laboratory technicians to detect and enumerate the bacteria and particles present in urine specimens.
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The Bliss HD microscopy system by Olympus America Inc. (Center Valley, PA).
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Olympus America Inc. (Center Valley, PA) introduced the Bliss HD, a high-definition virtual microscopy system. A comprehensive workstation incorporating a dedicated microscope stand, scanning instrumentation, and powerful, easy-to-use software, the system offers the highest optical performance commercially available for virtual slide scanning. The system offers a high degree of flexibility, allowing multiple-magnification scanning as well as an option for high-resolution oil immersion scans. Its Virtual Z feature allows capture and display of multiple Z focal planes for true virtual microscopy applications.
Randox Laboratories (Antrim, UK) released the Evidence immunoassay analyzer, which has a throughput of 108 samples per hour multiplied by the number of tests on the biochip, which can be up to 23 tests. The analyzer has a host of features, including a clear and easy-to-operate graphical user interface, regular updates of onboard inventory details, quality control software, retrospective reporting, results archiving, test selection profiles, and laboratory information management system connectivity. The analyzer is supported by Randox quality controls and a continual Internet-driven peer group reporting scheme.
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The RX Imola clinical chemistry analyzer by Randox Laboratories (Antrim, UK).
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Randox also released the RX Monza, a semiautomated clinical analyzer ideal for low-throughput testing. The RX Monza has been designed to be robust, reliable, easy to use, and require little maintenance. The analyzer has 192 programmable tests covering a wide range of chemistries including 64 direct-access tests with one-touch selection. This compact analyzer has an integral screen, keyboard, and printer. Features include preprogrammed tests, adjustable flow-cell temperature, and an enhanced quality control package with Levey-Jennings charts.
Roche Diagnostics (Indianapolis) launched its Cobas c111 system, a clinical chemistry analyzer designed specifically for low- to medium-volume laboratories. The compact system utilizes the same components and reagents as its larger, central-lab Cobas Integra siblings, enabling smaller labs to benefit from equivalent performance and quality results. Featuring next-generation technology, the automated system is easy to use and maintain, and launches with a broad test menu. The analyzer can run up to 80 chemistry and 150 electrolyte tests per hour, and can host up to 17 onboard tests.
Roche also announced the new Modular Analytics Evo system. The system combines Hitachi reliability and performance with significant software enhancements to optimize operational efficiency and increase lab productivity. These enhancements include stat handling via Super Stat mode, which provides faster stat turnaround time, improved quality control and calibration management, and rack flow enhancements. It is available in up to 96 different integrated chemistry and immunoassay configurations, and offers a broad and growing test menu of more than 140 assays.
Siemens Healthcare Diagnostics launched the Advia 2120i Hematology System, the latest addition to the company’s family of hematology instruments used in the clinical laboratory. The system provides the most current technology for white blood cell differential, red blood cell, reticulocyte, and platelet and cerebral spinal fluid testing. The system benefits all sizes and types of hematology laboratories, including routine, specialty, university, oncology and research laboratories.
Veridex LLC (Raritan, NJ) received from FDA an expanded clearance for the CellSearch System to be used as an aid in the monitoring of metastatic prostate cancer patients. The system currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients. The system identifies and counts circulating tumor cells in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast, colorectal, or prostate cancer, and can do so earlier than the current standard of care.
Data and Information Management
In the data and information management area, Eric Olson, vice president of informatics and ebusiness at Siemens Healthcare Diagnostics, identified the following trends:
Information technology (IT) enables improved IVD workflow. Healthcare providers and vendors are increasing their focus on IT as a vital tool in optimizing operational and information workflow in the clinical laboratory. This trend should continue as vendors develop IT solutions designed to improve efficiency and optimize information management in the lab.
IT solutions facilitate integrated diagnostics. Healthcare providers are pursuing IT resources that are able to integrate information at the patient level across key diagnostic modalities, including clinical laboratory and imaging. IT offerings should start to deliver greater levels of integration and decision support capability targeted to improve quality of care across the patient care continuum.
Renewed energy for standardization of laboratory IT communications. Organizations such as the IVD Industry Connectivity Consortium are driving standardization in order to modernize communications between IT systems and analyzers, and enhance system connectivity for clinical laboratories.
Continued rapid adoption of autoverification. Clinical laboratories are continuing the rapid adoption of auto-verification technology to reduce the amount of time spent reviewing normal results and increase the quality of the result review process.
Increased importance of physician connectivity. As physicians adopt electronic medical records, it is becoming important for clinical laboratories to support IT integration with these customers.
Outsourcing of IT. An interesting movement in the IVD industry toward the outsourcing of IT expertise is occurring as several IVD vendors turn to independent software developers to provide IT solutions.
More comprehensive IT solutions. Major laboratory information system (LIS) vendors are expanding IT offerings to include electronic health records, electronic medical records, financial systems, and other healthcare IT systems.
Advent of personal health records attracts bigger software players. IT giants such as Microsoft and Google are becoming involved in the IVD business via their Healthvault and Google Health initiatives. This trend should continue as providers sign up to participate.
Beckman Coulter released Remisol Advance, the next generation of data management software that helps make autovalidation achievable. Backed by technical training that includes both onsite and offsite options, as well as post-maintenance support and troubleshooting, the software improves the sample workflow by communicating between the instruments, automation system, and the LIS. This enables clinical labs to consolidate test information from various instrument systems and manage the data according to the lab’s workflow in real time.
BioTek Instruments Inc. (Winooski, VT) announced a new software tool for clinical laboratories using the ELx800 and ELx808 microplate readers. The Gen5CL data collection and analysis software combines the convenience and security of preprogrammed clinical diagnostic assays with the power and flexibility of a PC-based application. The PC-based interface provides greater flexibility in data analysis and output options than on-board microplate reader programs, including LIS system compatibility and data/protocol storage.
Data Innovations (South Burlington, VT) announced the release of Instrument Manager version 8.07, which includes a new archiving feature, a redesigned rules interface, and enhanced backup functionality. The archiving capability enables the long-term storage of data in a separate database for historical and record-keeping purposes. Archived data are viewable in Instrument Manager, and can optionally be sorted, cataloged, and stored as PDF files for offline long term storage.
Siemens announced the worldwide availability of version 2.0 software for the Rapidlab 1200 series blood gas system. The new software is a required upgrade for all existing customers and will be included on all Rapidlab 1200 systems in the future. The version 2.0 software continues to build on the performance and proven technology of the Rapidlab 1200 system by adding many new capabilities that can enhance patient care, including fully customizable panels for ease of use with frequently run profiles.
Point-of-Care Devices
During the past couple of years, point-of-care testing has seen a significantly higher level of development than in previous years. One of the key factors driving this trend is the merger and acquisition activity resulting in about $2.5 billion worth of investment in point-of-care companies.
One of the major acquirers of point-of-care companies lately has been Inverness Medical Innovations. After a lengthy battle with Beckman Coulter, Inverness finally acquired Biosite for more than $1.6 billion. Biosite was very successful in point-of-care cardiac testing with its Triage platform.
Inverness also completed its acquisition of Cholestech through the merger of a wholly owned subsidiary with and into Cholestech. Through this purchase, Inverness expects opportunities to develop between Cholestech and its existing point-of-care organization.
Opportunities presented by the rapid development of the point-of-care market have attracted a number of companies to enter this segment. Most of the companies are small, start-up firms that are developing proprietary technologies, such as Epocal Inc. (Ottawa, ON, Canada) and Oxonica (Oxford, UK). However, Royal Philips Electronics (Amsterdam) had also announced its intent to enter the point-of-care market with decentralized rapid diagnostic testing systems using its proprietary magnetic biosensor technology.
Last year, Philips signed an agreement with Cozart (Oxford, UK), a company that specializes in drugs-of-abuse testing. Cozart and Philips plan to work jointly to launch a new drugs-of-abuse testing system by mid-2009. Philips also increased its equity stake in Cozart to about 9%.
Abbott Diagnostics received FDA approval for the FreeStyle Navigator continuous glucose monitoring system for people with diabetes. Designed to measure glucose levels discretely and continuously, the system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. The system offers a number of key advances for people with diabetes who require insulin and want to manage their disease closely. The system monitors glucose levels by measuring and transmitting glucose information once per minute to a pager-sized receiver, which can be clipped to a belt or carried in a pocket or purse.
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The StatStrip Xpress by Nova Biomedical (Waltham, MA).
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Nova Biomedical (Waltham, MA) introduced its StatSensor creatinine monitoring system, an advanced, handheld creatinine monitoring system that enables simple, rapid, and accurate assessment of renal function by fingerprick capillary blood sampling at the point-of-care. Incorporating the Multi-Well test strip technology adapted from Nova’s hospital glucose monitoring system, this new device allows creatinine to be measured with a simple 30- second test in the emergency department, radiology, oncology, or other point-of-care areas where renal function must be assessed.
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The CoaguChek XS Plus by Roche Diagnostics
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Roche Diagnostics launched its CoaguChek XS Plus system, which offers built-in controls and optional external liquid controls to help nonwaived clinics monitoring anticoagulation ensure accurate clotting-time test results for patients taking blood thinner medication. The handheld, battery-powered system has the ability to store up to 500 patient and/or liquid quality control results that can be searched by patient, date, and time. The meter also is designed for data management connectivity with patient ID, operator lockout, and quality control lockouts.
Siemens Healthcare Diagnostics launched the DCA Vantage analyzer, a point-of-care diabetes patient management platform reporting glycosylated hemoglobin (HbA1c), microalbumin/creatinine, and albumin-to-creatinine results for diabetes management. The analyzer is critical for monitoring a patient’s glycemic control and helps physicians encourage patient compliance by delivering actionable test results during a patient visit. The system delivers the simplicity and convenience required at the point-of-care with no sample or reagent preparation steps.
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The Stat-Site M beta-HB System by Stanbio Laboratory (Boerne, TX).
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Stanbio Laboratory (Boerne, TX) released the Stat-Site Mß-HB system, which improves upon the original Stat-Site/KetoSite platform for the quantitative determination of beta-hydroxybutyrate in serum or plasma.This test is specific for beta-hydroxybutyrate, the predominant ketone body. It is not affected by interfering substances and shows high linearity up to 7.0 mmol/l. The system employs a small glucose-type meter and a unique ß-HB test card. The card is placed in the meter, after which a drop of serum or plasma is placed in the sample well.
Immunoassays
In the area of immunoassays, some interesting trends have emerged. IVD manufacturers continue to see the development of increasingly sensitive detection methods that surpass the limits of detection that can be achieved with traditional immunoassay formats. Unfortunately, many of these new methods require specialized instrumentation that is either not available or not affordable for smaller clinical laboratories.
Another emerging trend in immunoassays is the move toward more personalized testing and screening of individual therapies. Some new assays are beginning to answer the question of whether specific drugs are doing what they are supposed to do in individual patients. As molecular techniques identify increasingly specific genetic variabilities, more specific targets for developing antibodies have allowed immunoassays to answer not only quantitative but also functionality questions. This trend should continue into the foreseeable future.
Immunoassay technologies themselves are also evolving. The use of enzymes continues to be replaced by more sensitive fluorescent and chemiluminescent technologies. In addition, immunoassays are continuously moving toward offering multiple analyte measurements in single kits. This trend is again in line with offering more personalized testing for individuals.
Abbott Diagnostics launched the Verax Platelet PGD test, a first-generation, single-use, rapid qualitative immunoassay test that detects bacteria in human platelets. Abbott signed an exclusive distribution agreement with Verax Biomedical Inc. (Worcester, MA) for worldwide rights to market and distribute the test. The test is an easy-to-use, disposable device used to detect the presence of a broad range of bacterial contaminants in platelets prior to blood transfusion. The test is designed for use in quality control testing of leukocyte reduced platelet units collected from blood donors and to detect both aerobes and anaerobes.
Abbott also received approval from FDA for Architect Core-M, an automated hepatitis B assay for use on its Architect instruments. The test is a qualitative assay for the detection of immunoglobulin (IgM) antibodies to hepatitis B core antigen virus. The assay is one of several tests that help in the diagnosis of hepatitis, and completes the panel of tests for acute viral hepatitis on the Architect system. The panel comprises four assays (HAVAB-M, HBsAg, Core-M and Anti-HCV) and is used to aid in identifying and diagnosing patients infected with hepatitis A, hepatitis B, and/or hepatitis C.
Aureon Laboratories Inc. (Yonkers, NY) announced the introduction of Prostate Px+, the first commercial test to predict prostate cancer progression and disease recurrence at the time of diagnosis. The test is based on the results of a large clinical study utilizing data and samples from a cohort of 1027 men assembled from the Mayo Clinic, Uppsala University, University of Connecticut, and Duke University Medical Center. In validation, the company’s predictive model identified twice as many high-risk events in low and intermediate risk patients as the best available method.
BD Diagnostics received clearance from FDA for the BD GeneOhm StaphSR assay. This new assay rapidly and simultaneously identifies two deadly healthcare-associated infections, Staphylococcus aureus and methicillin-resistant Staphylococcus aureus, from patients with positive blood cultures. The assay provides results within two hours, directly from positive blood cultures. It is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results.
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The gTox Flow Kit by Beckman Coulter Inc. (Fullerton, CA).
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Beckman Coulter introduced the gTox flow kit, a new flow-cytometric approach to genotoxicity testing. This mouse micronuclei assay is designed to evaluate the ability of a compound to cause chromosomal damage. It detects micronuclei formed from chromatin that are displaced as a result of chromosomal breakage. The assay enumerates micronucleated red cells in peripheral blood of treated mice. It is ideal for preclinical drug candidate testing, environmental testing, and other academic and commercial toxicology applications.
Beckman also expanded the drugs-of-abuse test menu on its UniCel DxC and Synchron family of chemistry systems with the release of the DRI Ecstasy assay. The new assay aids mid- to large-volume hospitals and reference laboratories in the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/ml. The assay uses a specific antibody, which can detect ecstasy drugs in urine with minimal cross-reactivity to various amphetamine compounds.
Biologix Diagnostics LLC (Lenexa, KS) announced the introduction of the patented TPMT Activity assay, an assay designed to determine quickly and accurately the activity levels of the TPMT enzyme, thereby evaluating a patient’s therapeutic and/or toxic response to often-used thiopurine drugs. The assay utilizes the more accurate and more decisive method of phenotyping, where TPMT activity is typically measured from lysed red blood cells, which corresponds to the level of TPMT enzyme in human liver, kidney, and normal lymphocytes.
bioMérieux received 510(k) clearance from FDA to market its Vidas B·R·A·H·M·S PCT. The test will be used with critically ill patients on their first day of admission to the intensive care unit as an aid to assess their risk for progression to severe sepsis and septic shock. The Vidas platform is well suited to emergency situations, with this test providing results in just 20 minutes. The new test completes the large Vidas emergency panel available in the United States, which includes markers of cardiac necrosis (Vidas Troponin I, CK-MB) and venous thromboembolism (Vidas D-Dimer Exclusion).
bioMérieux also received 510(k) clearance from FDA to market Vidas NT-proBNP, a test that helps the diagnosis of heart failure. VIDAS NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a quantitative marker of heart stress with the potential to detect all stages of heart failure, even the early stages, which can be difficult to detect. The test provides objective diagnostic information that helps clinicians distinguish heart failure from other disease states with similar clinical symptoms, for instance lung diseases or pulmonary embolism.
Bio-Rad Laboratories Inc. (Hercules, CA) introduced to the U.S. market its MRSASelect test, a chromogenic medium used for the rapid screening of methicillin-resistant Staphylococcus aureus (MRSA). With high sensitivity and specificity as well as rapid and direct identification, the test can identify MRSA carriers in 24 hours. The test is performed on nasal specimens from patients and healthcare workers to screen for MRSA colonization. Chromogenic media are used to grow bacteria in the laboratory and identify them based on a color reaction. With this medium, MRSA can be differentiated from other microorganisms.
Dade Behring received clearance from FDA for use of its MicroScan Synergies plus Gram-positive panels. The new technology used in the panels allows rapid two-hour identification of bacteria and same-day test results for detecting certain antibiotic-resistant bacteria that cause serious health threats in a hospital environment. Some of the antibiotic-resistant bacteria that may be identified on the same-day tested are the following: methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococcus.
Kinase Scientific LLC (Keane, NH) announced that the U.S. Patent and Trademark Office granted approval to its application entitled “Rapid Test For Hemolytic Streptococcus,” U.S. Patent No. 7,316,910 B2. The patent discloses a saliva screening test, potentially adaptable for home use, to diagnose whether a sore throat is caused by the streptococcus bacterium (strep throat). The patented technology involves the use of a reagent for the detection of an extracellular active protein, or biomarker, produced only when clinically significant betahemolytic streptococcal bacteria are present in a biological fluid.
Magnisense (Paris) launched MIAplex, a new magnetic bead immunoassay technology that allows simultaneous multiparametric testing of biological samples. MIAplex builds on MIAtek, a detection technology making possible the development of magnetic immunoassays using magnetic beads as labels for monoparametric testing. MIAplex has wide-ranging application potential, including medical and veterinary diagnostics, food inspection, and environmental and security monitoring.
Orgentec Diagnostika (Mainz, Germany) developed Liver-7-Line, an immunoblot test system for serodiagnostics of autoimmune-related liver diseases. Using this test, it is possible for the first time to differentiate antismooth muscle antibodies (ASMA) by the immunoblotting technology. In addition to autoantibodies against ASMAs (e.g., F-actin, myosin, and desmin), the immunoblot test detects antimitochondrial antibodies against M2 antigen (AMA-M2), antisoluble liver/liver pancreas antibodies (anti-SLA/LP), antiliver kidney microsomal 1 (anti-LKM-1), and antiliver cytosol 1 antibodies (anti-LC1).
Ortho-Clinical Diagnostics (Raritan, NJ) announced the availability of the Vitros Troponin I ES assay, an improved-sensitivity troponin I assay. The assay quantitatively measures cardiac troponin I in human serum and plasma with the level of sensitivity and precision described in the Joint European Society of Cardiology/American College of Cardiology Committee consensus document, improving the ability to differentiate between healthy and unwell patients. The assay is designed and integrated with the Vitros ECi /ECiQ System to help ensure quality, accurate results using Intellicheck technology.
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The Vitros Anti-HIV 1+2 Assay by Ortho-Clinical Diagnostics (Raritan, NJ).
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Ortho-Clinical also announced FDA approval of a diagnostic assay for the detection of antibodies to HIV types 1 and/or 2 (anti-HIV-1 and anti-HIV-2). The new Vitros Anti-HIV 1+2 assay can be run in a fully automated random access format on the Vitros ECi/ECiQ Immunodiagnostic System, with results readily available in less than 50 minutes. The tests can be run at any time, in any order, and with other types of tests. The assay was codeveloped with Chiron, a business unit of Novartis Vaccines and Diagnostics Inc. (Basel, Switzerland).
Prodesse Inc. (Waukesha, WI) announced the commercial release of its CE-marked ProFlu+ assay for European and other customers outside the United States. The assay rapidly and accurately detects influenza A virus, influenza B virus, and respiratory syncytial virus in a single reaction. Clinical trial sites reported that the real-time technology used in the assay makes the detection process far easier than culture. The assay yields answers in three hours while culture can take from a few days to as long as two weeks.
Prodesse also announced the commercial release of its CE-marked ProGastro Cd assay for European and other customers outside the United States. It is available in the United States as a research use only product for nonclinical use. The assay rapidly and accurately detects toxigenic strains of the Clostridium difficile bacterium. The real-time polymerase chain reaction (PCR) technology used in the assay makes the detection process far easier than the gold- standard cytotoxin assay, yielding answers in as little as three hours.
Randox Laboratories introduced a range of 25 liquid and ready-to-use protein assays. The latex-enhanced protein assays contain microscopic latex particles to amplify the protein-reagent reaction and increase the sensitivity of the assays. The company introduced latex-enhanced protein assays where ultralow levels of the protein are clinically significant, for example C-reactive protein and ferritin. The protein assays are supported by a comprehensive range of multi and mono quality controls and calibrators supplied with instrument-specific and method-specific values.
Seegene Inc. (Seoul, Korea) introduced a new STD/HPV diagnostic test capable of simultaneously detecting the most common bacteria and viruses causing sexually transmitted diseases. The new Seeplex STD/HPV test screens for Chlamydia trachomatis, Neisseria gonorrhoeae, as well as 14 high-risk human papillomavirus (HPV) subtypes and 5 low-risk HPV subtypes in a single reaction tube. The new diagnostic test enables healthcare providers to determine quickly, accurately, and cost-effectively the prevalent STD/HPV infections in patients.
Siemens Healthcare Diagnostics launched the Loci Folate, Loci B12, and Loci Ferritin tests for use on the Dimension Vista 1500 Intelligent Lab system, an ultra-integrated chemistry analyzer. These tests are used by physicians to diagnose and monitor anemia in patients, and further expand Siemens’ Loci immunoassay test menu for the Dimension Vista system. Through the use of the Loci advanced chemiluminescence technology, the company provides clinical laboratories greater levels of testing sensitivity for immunoassay testing and a broad test menu capability on the Dimension system.
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The Rely H. pylori Rapid Test by Stanbio Laboratory (Boerne, TX).
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Stanbio Laboratory released the Rely H. pylori rapid test, a new CLIA-waived rapid test for the detection of H. pylori in whole blood, serum, or plasma. The test provides simple, fast, and cost-effective detection of H. pylori. The simple, easy-to-use, two-step whole blood procedure requires minimal training. Multiple sample types provide efficient testing flexibility. All testing materials are included in the kit to minimize staff hands-on time and convenient room- temperature storage and extended dating help to manage inventory costs.
Stanbio also launched the Rely Mono rapid test, a CLIA-waived rapid test for the qualitative detection of infectious mononucleosis. Each complete test kit provides a fast, convenient, sensitive, and economical approach to the detection of infectious mononucleosis in whole blood, serum, or plasma. Available in a 20-test configuration, the test kit includes individually pouched cassettes, sample buffer, disposable sample droppers, disposable heparinized capillary tubes with dispensing bulb, and positive and negative controls.
Molecular Diagnostics
During the past year, the IVD industry has been watching warfarin as a test case in the continually evolving field of pharmacogenetics. The blood thinner medication was thought by many to be a low-hanging target for early and widespread adoption of genetic testing in the practice of medication management. In August 2007, the medication prescribing information was changed to include information about genetic testing. While this was not the first medication to do so, warfarin may have been the most anticipated. As of May 2008, FDA has cleared three new assays for warfarin genotyping. Those assays were developed by AutoGenomics (San Diego), Nanosphere (Northbrook, IL), and ParagonDx (Morrisville, NC).
“Even though many clinical labs are still using laboratory-developed assays, it has become apparent that the adoption of genetic testing for warfarin, and for most medications, takes more than a laboratory assay,” says Bonny L. Bukaveckas, PhD, assistant professor, department of pharmacy and pathology at the Virginia Commonwealth University (Richmond, VA). “A way to integrate that moderate-complexity testing into the clinical workflow and a way to provide just-in-time dynamic information for test result interpretation, and possibly genetic test reporting standards, have all emerged as development areas in molecular diagnostics.”
The expansion of IVD technologies beyond analytics is a trend that is likely to continue because the perceived need for personalized medicine is high. It is likely that integrated molecular diagnostics products will be developed and launched in the coming year which connect the lab assay with sophisticated informatics tools. The IVD industry should anticipate new partnerships emerging between IVD companies and IT companies to develop these new tools.
AdvanDx Inc. (Woburn, MA) announced the launch of vanA/B Evigene in Europe, the first locked nucleic acid-based IVD test for detecting vancomycin-resistant Enterococci and vancomycin-resistant Staphylococcus aureus in positive blood cultures and clinical isolates. This test combines the high specificity of locked nucleic acid probes with Evigene, a signal amplified sandwich hybridization assay platform, to detect rapidly and accurately both the vanA and vanB genes that confer vancomycin resistance in Enterococci and Staphylococcus aureus.
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The Agencourt DNAdvance System by Beckman Coulter Inc. (Fullerton, CA).
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Beckman Coulter introduced the Agencourt DNAdvance system, a new extraction kit for DNA isolation and purification from mammalian tissue samples. The system delivers a combination of recovery, yield, and purity not available with any other kit on the market today. It incorporates the patented solid-phase reversible immobilization paramagnetic-bead-based nucleic acid purification technology. The system is automated on the Biomek NXP and FXP laboratory automation workstations to process three 96-well plates in about 75 minutes without the use of organic solvents, vacuum filtration, or centrifugation.
Cepheid (Sunnyvale, CA) introduced its GeneXpert Infinity-48 high-throughput system. The newest addition to the GeneXpert family of molecular diagnostic testing systems delivers the world’s first and only fully-automated random-access system designed for management of the entire molecular testing work flow. After a sample is loaded into a GeneXpert cartridge, the system does the rest. The system also manages the sample data, cartridge loading and unloading, and reporting of test results.
CombiMatrix Corp. (Mukilteo, WA) announced that its subsidiary, CombiMatrix Molecular Diagnostics, completed clinical validation and commercially launched the HerScan test, the first bacterial artificial chromosome comparative genomic hybridization array-based test for breast cancer. The test is designed to detect amplification of the Her2 gene in early breast cancer while simultaneously giving clinicians a complete profile of a patient’s tumor genome. The test is designed to give pathologists and oncologists an objective measure of the Her2 gene copy number with simultaneous analysis of the entire tumor genome.
DxS Ltd. (Manchester, UK) announced the addition of a B-RAF mutation detection kit to its range of oncogene mutation products. This assay detects V600E, the most common mutation in the B-RAF oncogene, which occurs in many types of cancers, including melanoma, colorectal, and lung. The kit is highly selective and robust, detecting the mutation in a background of wild-type genomic DNA in a real-time PCR assay based on the Scorpions technology. The assay can detect less than 1% of mutant in a background of wild-type genomic DNA and has a limit of detection of five copies or below.
Genewave SAS (Palaiseau, France) introduced HybLive, its fully automated microarray platform. This platform combines hybridization, washing, melting, and real-time fluorescence imaging in a compact benchtop package. The device is the first open microarray platform allowing real-time measurement of the on-slide hybridization and melting of target molecules to thousands of probes simultaneously. It enables a variety of applications such as rapid verification and validation of probe design, environmental sample monitoring, multiplex on-chip melting curves determination, and on-chip DNA and protein interaction studies.
Luminex Corp. (Austin, TX) received 510(k) clearance from FDA for its xTAG respiratory viral panel (RVP). This test is the first FDA-cleared assay to detect and identify simultaneously 12 viruses and viral subtypes that together are responsible for more than 85% of respiratory viral infections. With a single patient sample, the test can assess the presence or absence of 12 viral targets and provide qualitative results in a few hours. xTAG RVP is the first test of any kind cleared to detect human metapneumovirus, the first test cleared for influenza A subtyping, and the first molecular test cleared for adenovirus.
Pathwork Diagnostics Inc. (Sunnyvale, CA) announced that FDA has cleared its Pathwork tissue of origin test for use in determining the origin of uncertain tumors. The test analyzes a tumor’s gene expression pattern to help pinpoint the source of hard-to-identify tumors and is the first test of its kind to receive FDA clearance. The test uses a microarray to measure the expression pattern (comprising more than 1500 genes) in the uncertain tumor and compares it to the expression patterns of a panel of 15 known tumor types (representing 60 morphologies overall) to help determine the tumor’s origin.
Siemens Healthcare Diagnostics announced that its Versant 440 molecular system has been approved for marketing by FDA for use with the Versant HCV RNA 3.0 assay for management of HCV-infected patients undergoing antiviral therapy. The system is a branched DNA system designed for flexible walk-away automation. Its single-room technology and consolidated footprint allow the system the flexibility to fit anywhere in the clinical laboratory. The system streamlines workflow by integrating bar code data entry, automated reagent processing, and signal amplification detection.
Conclusion
With new molecular products on the market, an increased demand for instruments with greater automation and connectivity, and ever-increasing opportunities for bringing point-of-care tests for a variety of samples to market, it has been a good year for IVD manufacturers. However, consolidation in the IVD industry could continue to shape significantly and influence the future direction of the industry by prompting a paradigm shift in how IVDs are developed and delivered.
In addition to smaller, less-expensive, faster, and more- accurate traditional IVDs, IVD manufacturers have continued to develop new tests that are tied intimately to pharmaceuticals. More and more of these personalized medicine IVDs will continue to be introduced into the marketplace in upcoming years.
Moreover, future advances in IVDs will bring diagnostic testing even closer to the patient, and provide more-accurate, faster, and simpler testing to the marketplace. As IVD manufacturers deliver on the promise for ever better diagnostics, IVD Technology will be here to take note of their progress.
Richard Park is editor of IVD Technology.
