|The Year in IVDs|
Reviewing a selection of the advanced new products and technologies that IVD manufacturers developed and launched in 2009-2010.
While the underlying theme in the IVD industry during the past few years had been consolidation, this year’s theme has been surviving the global recession. Nonetheless, some industry analysts believe that the IVD market will not be stalled by economic conditions for a variety of reasons. For example, Kalorama Information (New York City) says it sees no reason to revise its forecast of a $58.6 billion industry by 2014.
|The Clinitek Status+ Analyzer by Siemens Healthcare Diagnostics (Deerfield, IL).|
“The economic conditions have not changed our forecasts for the routine IVD market,” says Shara Rosen, an IVD industry analyst for Kalorama Information. “Expansion of the IVD market will continue at its traditional rate of 6% per year.”
Demand for healthcare and thus IVD tests in all the major markets continue to be driven by aging populations and the increased incidence of conditions such as cancer, diabetes, cardiovascular disease, arthritis, and obesity. But even though there is an emerging menu of specialized tests for such diseases, routine tests are used as the first line of diagnosis. Consequently, Kalorama still contends that market growth for chemistries, immunoassays, hematology, coagulation, microbiology, and histology/cytology tests are related to an increase in the volume of tests performed rather than higher pricing, and more demand for healthcare is expected to translate into greater test volume.
Kalorama also says that the aging population, demand for healthcare, emerging markets, and the new healthcare reform law still bode well for testing. But the simplest explanation for how the IVD industry will get through the current economic crisis is that the industry has already taken its hits in previous recessions.
“Since the late 1980s, healthcare payers have systematically frozen reimbursement rates for the existing group of tests and have imposed strict utilization guidelines for the adoption of new tests,” says Rosen. “70% of hospitals buy IVD equipment through group purchasing organizations at rock-bottom prices. Since the IVD industry did not experience the explosive growth seen in some medical devices, it will not see a harsh retraction.”
It remains to be seen how the fallout from the recession will affect 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.
|Alere International (Morges, Switzerland) launched three new next-generation products: Troponin I, Cardio2, and Cardio3.|
Instrumentation and Automation
A report published by Kalorama Information (“The Worldwide Market for Lab Automation”) stated that, “When the trend toward clinical laboratory automation first began in the early to mid-1990s, much of the talk about automation focused on automating all lab functions: total laboratory automation (TLA). Targeted to the largest, highest volume laboratories, TLA requires a major financial commitment (i.e., several millions of dollars) and the space for installing equipment. But TLA is not an affordable or practical solution for the majority of small to mid-sized hospitals and other diagnostic laboratories. The trend for most clinical labs, and for many automation system manufacturers, is toward modular automation, which includes consolidated and integrated analyzers, independent work cells or self-contained work stations, and automation for transport, handling, and pre- and postanalytical processes.”
Abbott Laboratories (Abbott Park, IL) showcased the ArchitectPlus, the enhanced Architect family of immunochemistry analyzers, at the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo. This system offers enhanced automation, workstation consolidation, high efficiency and labor savings for laboratories of all sizes.
BD Diagnostics (Franklin Lakes, NJ) launched the BD Bactec MGIT 320 Mycobacteria Culture System, a new, smaller capacity system to quickly and accurately detect tuberculosis. Designed for laboratories with smaller volumes, the BD Bactec MGIT 320 System is half the physical size of the BD Bactec MGIT 960 System. The new, smaller system holds 320 tubes, for an annual capacity of approximately 2700 specimens per year. It makes optimal use of valuable laboratory space and offers a flexible configuration as either a bench-top or stand-mounted instrument.
Beckman Coulter Inc. (Brea, CA) extended the range of its LS 13 320 particle size analyzer to allow high-resolution, reproducible measurement of samples from 0.017 to 2000 µm. The enhanced LS 13 320 also adds Rosin-Rammler and Folk & Ward Phi methods to its full complement of standard analytical capabilities.
Bio-Rad Laboratories Inc. (Hercules, CA) announced the launch of its IH 1000 blood screening system. The IH 1000 is a fully automated, high-throughput system designed for the blood transfusion laboratory utilizing the industry-accepted gold standard ID-system gel card technology. The new system offers full automation, integrated QC and validation, intuitive software, and walk-away convenience for blood banking laboratories.
|The Dimension Vista 1500 Intelligent Lab System by Siemens Healthcare Diagnostics.|
Luminex Corp. (Austin, TX) introduced Magpix, an analytical instrument that is capable of performing up to 50 tests on a single sample and providing nearly 5000 data points in less than an hour. EMD Millipore (Billerica, MA) is the first value-added reseller that will distribute the Magpix instrument worldwide. The instrument was designed to meet the needs of laboratories, academic researchers, and scientists, who to date have not been able to take advantage of the power of multiplexing because of resource and space limitations.
With the launch of the QIAsymphony AS, Qiagen NV (Venlo, The Netherlands) extended its full range of assay and detection solutions. This new module of the QIAsymphony series provides fully automated setup of Qiagen assays and PCR kits and combines Qiagen’s experience in sample and assay technologies on a single platform.
The AACC Clinical Lab Expo was also the setting for the official unveiling of the latest addition to the Evidence family of immunoassay analyzers by Randox Laboratories Ltd. (Antrim, UK). The Evidence Evolution is the world’s first fully automated, random-access biochip testing platform. Pushing the boundaries of laboratory testing, the Evidence Evolution offers complete consolidation on one platform. Established and proven biochip array technology provides limitless multiplex capabilities, enabling simultaneous testing from a single small-volume sample. Coupling such advanced technology with the test menu enables the Evidence Evolution to provide laboratories with patient-profiling capabilities while saving time and costs.
Being designed to bring next-generation consolidation to the high-volume testing lab, the cobas 8000 analyzer series by Roche Diagnostics Corp. (Indianapolis) is intended for labs processing more than two million clinical chemistry and immunoassay tests per year. The series consists of four analytical chemistry/immunoassay modules (cobas c 701, cobas c 502, cobas ISE module, and cobas e 602) that can be configured into 24 unique combinations to fit the needs of a wide variety of testing environments. (This product is currently pending FDA 510(k) clearance).
Developed to help streamline a lab’s workflow and manage the entire life cycle of a sample tube, the cobas p 501 post-analytical unit by Roche is being designed to provide automated storage and retrieval for up to 30,000 sample tubes in a compact footprint (17 linear feet). It is being designed to connect directly to Roche automation, store up to 400 samples per hour in a convenient refrigerated environment, and automatically dispose of samples after a designated period of time. The unit is also being designed to receive sample retrieval requests for add-on tests immediately through integration with the laboratory information system (LIS).
|The Panbio Dengue Early Rapid immunochromatographic test by Inverness Medical Innovations (Waltham, MA).|
Siemens Healthcare Diagnostics (Deerfield, IL) added new automation capabilities for clinical laboratories: connectivity of the Dimension Vista 1500 Intelligent Lab System to Advia Automation Solutions combines the benefits of an integrated chemistry and immunoassay system with the productivity and expanded capacity of high-volume automation. In addition, the new Advia Centrifuge Module addresses growing test volume and turnaround requirements for labs with its increased specimen processing capacity.
Siemens also announced that the RapidLab 1200 series blood gas analyzers offer neonatal bilirubin (nBili) testing that detects elevated levels of bilirubin with a 60-second turnaround time. The Siemens nBili test provides fast, accurate results without increasing monthly operating costs. This Siemens test requires only 100 uL of whole blood measuring 2–30 mg/dl and can be conducted as part of a neonatal test panel that includes blood gas, pH, electrolytes, metabolites, total hemoglobin, and CO-oximetry. No additional reagents or sample preparation are needed for the Siemens nBili test.
In addition, the Advia Centaur XP Immunoassay System by Siemens has been enhanced such that it can seamlessly connect to the Immulite 2000, Immulite 2000 XPi, and Immulite 2500 immunoassay systems and the Advia 1800 system using Siemens VersaCell solution, providing mid-sized clinical diagnostic laboratories a flexible, cost-effective system for streamlining workflow and increasing productivity.
Data and Information Management
According to Ed Heierman, PhD, an informatics software architect at Abbott Laboratories, “I’ve seen an increased emphasis on improving the interaction lab personnel have with IVD instruments and information management systems. I think we’ll see IVD manufacturers improve user interfaces to minimize the interruption on the workflow of lab technicians through the use of technologies like RFID, smart phones, and tablets.
“For example, future systems might identify and authorize lab personnel with RFID tags, providing a hands-free login and allowing multiple personnel to efficiently interact with a system. With smart phones and tablets, it will be possible for operators to receive alerts, review information, and monitor progress without having to be physically in front of the instrument or the information system. Laboratory personnel become more efficient because these technologies integrate the software systems into the laboratory workflow, rather than interrupting users when interaction with the system is required.”
|The Elecsys Anti-HCV assay by Roche Diagnostics (Indianapolis).|
Beckman Coulter launched the Remisol Advance data-management system that links analyzers and laboratory information systems through a single workstation, providing technicians with a comprehensive real-time view of the clinical laboratory testing life cycle.
Designed to improve laboratory turnaround times and productivity and reduce medical errors, the Remisol Advance system manages the laboratory process from the initial test request, through verification and release of results, to the LIS. The new system is capable of managing Beckman Coulter instruments, including automation, chemistry, special chemistry; i-class integrated systems, immunoassay, hematology, and hemostasis platforms.
BioMérieux (Marcy l’Étoile, France) introduced Myla, a new middleware solution to improve connectivity, laboratory workflow, and information management. Part of bioMérieux’s full microbiology lab automation solutions and services, Myla is an intelligent browser-based application that consolidates and manages microbiology data generated from a variety of sources and converts such data into actionable information for treatment decisions. Designed to transform the way that laboratory managers and technicians work, Myla recaptures time spent on information retrieval and reporting activities through a simple dashboard-based user interface that provides full control of lab workflow.
Siemens Healthcare Diagnostics’ RapidComm Data Management and Connectivity Solution Version 3.0 provides point-of-care (POC) coordinators and laboratory managers a single interface with real-time access for managing multiple remote Siemens blood gas and urine analyzers, thereby standardizing testing procedures, facilitating compliance, and improving risk management for POC testing. The RapidComm system is used with RapidLab 1200, RapidLab 800, RapidPoint 400/405, RapidLab 248/348 blood gas analyzers, and the Clinitek Status Connect urinalysis system. Lab managers can monitor multiple analyzers in the same facility or network, even if they are far away.
Siemens also expanded its Clinitek Status POC urinalysis portfolio with the Clinitek Status Connect System, featuring flexible connectivity options to enhance testing oversight and streamline data management for hospital and physician-office based urine testing. The system is CLIA-waived.
|The Beckman Coulter Antibody Cocktail Preparation Workstation automatically combines antibodies and staining dyes from individual vials into tubes or vials staged on the Biomek NXp deck.|
The Clinitek Status Connect System integrates POC urinalysis data into electronic medical records, directly to an LIS, or via POC data-management systems. Additionally, Siemens’s proprietary POC data-management system for urinalysis and blood gas testing, the RapidComm Data Management and Connectivity Solution, can also connect to the Clinitek Status Connect System, helping to further streamline POC testing data.
In addition, Siemens announced the release of Prisca version 5.0 Prenatal Risk Calculation Software available in Europe, Asia, Africa, Latin America, and the Middle East. The upgraded version offers the industry’s only shared database that allows laboratories to compare data and integrate patient demographic factors into the analysis. Both of these features help to increase the accuracy of the median against which patient results are measured, ultimately improving the accuracy of the diagnostic results. The software’s expanded screening protocols also allow for greater precision in patient risk assessment.
According to David Pearman, global marketing manager, hemostatis/POC divisions, Helena Laboratories Corp. (Beaumont, TX), “The efforts of the IVD industry in international markets overshadow anything else I have seen in the past year, particularly in the realm of POC testing. Growth in global markets is clearly outpacing the balance comprised of the western markets. One driving force obviously is the growing economies of countries like China and Brazil, but in my experience, many areas that were traditionally coined ‘third-world’ countries also want technology including POC testing.
“The growth is analogous in many ways to what we have seen in the United States. As cost becomes less of a factor, end users are able to seek better technologies and thus deliver better patient care, and overall there is savings because patients can thus be segued to a more economical level of patient care. Many growing nations have relied on a handful of major hospitals, while minor facilities have been considered Band-aid stations at best. POC testing is giving the latter the opportunity to offer better customer satisfaction, and thus competition with the big institutions is arising. As with the United States, other markets are being driven by the awareness that the patient is not only a medical challenge but a customer that has alternative choices.”
Alere International (Morges, Switzerland) launched three new next-generation products: Troponin I, a single-analyte, improved-sensitivity Troponin I (TnI) test; Cardio2, a two-analyte panel consisting of the new Troponin I and BNP; and Cardio3, a three-analyte panel consisting of the new Troponin I, BNP, and CK-MB. These improved tests allow for earlier detection of even lower levels of TnI, which improves outcomes and benefits patients, hospitals, physician office laboratories, and cardiologists.
|The LS 13 320 particle size analyzer by Beckman Coulter Inc. (Brea, CA).|
Chembio Diagnostic Systems Inc. (Long Island, NY) developed the Dual Path Platform (DPP) immunoassay, for which they received a patent in 2007. DPP technology employs two separate and distinct membrane strips: one for sample migration and one for test reagents. DPP separates sample application from the conjugate, enabling improved sample flow control and binding efficiency between the sample and the test lines. Compared with conventional lateral-flow tests, Chembio’s DPP technology offers improved sensitivity and specificity and increased ability to accommodate challenging sample types, and is better suited for multiplex tests.
Instrumentation Laboratory (Lexington, MA) received FDA clearance to market the first-ever rapid-POC, lab-quality blood test for measuring total bilirubin (tBili) in newborns. The new tBili assay is performed on the company’s Gem Premier 4000 critical-care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the neonatal intensive care unit, rather than waiting up to an hour for results from the lab using traditional chemistry methods.
Randox Laboratories launched a new biochip analyzer that will save cardiac patients’ lives by providing immediate diagnosis at the point of care. The Randox Evidence MultiStat is a new desktop analyzer that offers up to eight cardiac results in 20 minutes. This new technology ensures the accuracy and precision of a commercial laboratory analyzer in the emergency department, delivering benefits for those patients with chest pains by rapidly identifying risk and enabling accurate clinical decisions.
Roche Diagnostics announced that FDA granted CLIA-waived status to the CoaguChek XS Plus system. This POC anticoagulation monitor offers connectivity and data-management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The CoaguChek XS Plus system works with the RALS-Plus information management system, which provides reporting and device management capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve their organizational efficiency.
Roche also received 510(k) clearance from FDA for the CoaguChek XS Pro system, a POC anticoagulation monitor with a built-in bar code reader that can automatically scan and capture operator and patient identification information. The bar code reader works in conjunction with the RALS-Plus information management system to help healthcare professionals save time and prevent errors that could occur from manually entering the information for PT/INR testing with patients on warfarin therapy.
|The Vitros Anti-HIV 1+2 Assay by Ortho Clinical Diagnostics (Raritan, NJ).|
Currently pending FDA 510(k) clearance, the Accu-Chek Inform II blood glucose monitoring system by Roche is designed to introduce several technological innovations to help improve patient safety and care, improve access to data, and enhance system durability at the point of care.
Siemens Healthcare Diagnostics added several new data integrity and quality control features on the Clinitek Status+ Analyzer, which provides enhanced clinical information and quality control for POC urinalysis testing. The new system is CLIA-waived. New features include auto-checks that help to ensure the accuracy and quality of test results, including an automatic humidity check on each test strip and automatic test strip identification. The Clinitek Status+ Analyzer also offers enhanced operator management capabilities, including operator lock-out to prevent unauthorized use. Expanded memory supports up to 700 operator identifications and 950 patient test results.
A report by Kalorama Information concluded that the future for immunoassays is a mixed bag. In the clinical lab, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment.
However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. The function of genes is measured by the presence of tangible products, such as proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post-genomic medicine.
FDA cleared the Architect HE4 (human epididymis protein 4) assay by Abbott Laboratories, a new diagnostic test to monitor ovarian cancer. Abbott’s new assay, the first automated test of its kind available in the United States, uses a simple blood test to aid in monitoring for the recurrence or progression of this disease.
FDA also approved the Architect HIV Ag/Ab Combo assay by Abbott, an innovative new diagnostic tool which will allow patients to be diagnosed earlier than ever before. Abbott’s Architect HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests. This new test will run on Abbott’s Architect family of diagnostic testing instruments and is already approved for use outside the United States.
|Beckman Coulter introduced four detection cartridges for the Paradigm Detection Platform: the AlphaScreen, GeneBLAzer, MultiTox-Fluor, and Fluorescence Intensity cartridges.|
AdvanDx (Woburn, MA) received FDA 510(k) clearance for a fast, 90-minute protocol for its E. faecalis/OE PNA FISH test. The faster protocol reduces the PNA FISH turnaround time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the United States and Europe demonstrated 100% equivalence between the 90-minute protocol and the original PNA FISH protocol, ensuring the faster protocol maintains the high sensitivity and specificity required versus slower conventional methods.
Beckman Coulter introduced Solastra, a comprehensive CE-marked panel of conjugated antibody cocktails for the characterization of hematolymphoid neoplasia by flow cytometry. The premixed and ready-to-use panels target the appropriate markers as recommended by the 2006 Bethesda International Consensus and are compatible with the WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues (2008 revised).
Beckman Coulter also expanded its menu for reproductive-disease-state management with the introduction of the Access Sex Hormone Binding Globulin (SHBG) assay for use in the differential diagnosis of conditions of chronic or excessive androgenic activity. The Access SHBG assay may also be used in conjunction with the Access Testosterone Assay to provide a calculated free androgen index.
bioMérieux also announced FDA approval of the Vidas Free Prostate Specific Antigen test to aid in the diagnosis of prostate cancer. The test is used in tandem with bioMérieux’s Vidas Total Prostate Specific Antigen test, which is used to screen an asymptomatic population for the early detection of prostate cancer in combination with physical examinations. The Vidas Free PSA test is used when prostate cancer is suspected and gives doctors additional information to determine if a biopsy is necessary, minimizing unnecessary invasive medical procedures.
Bio-Rad Laboratories introduced the BioPlex 2200 MMRV IgG kit for use on the company’s BioPlex 2200 system. The MMRV IgG kit (measles, mumps, rubella, and the varicella-zoster virus) provides simultaneous results for the four tests that are commonly ordered together to determine a patient’s susceptibility to MMRV. The BioPlex 2200 MMRV IgG kit offers the advantage of multiplexing to deliver test results from a single patient sample. As a result, labs are able to generate test results quickly and with less effort.
|Beckman Coulter introduced Solastra, a comprehensive CE-marked panel of conjugated antibody cocktails for the characterization of hematolymphoid neoplasia by flow cytometry.|
Dominion Diagnostics (North Kingstown, RI) launched a highly specific quantitative benzodiazepine assay that is run by ultra-performance liquid chromatography tandem mass spectrometry. Dominion’s benzodiazepine assay is one of the most extensive profiles performed for this drug class by any specialized laboratory in the industry. By identifying specific analytes and/or their metabolites in the commonly prescribed benzodiazepine class, this assay provides practitioners the ability to identify accurately and quickly patients who may not be adhering to current prescription regimens or are reluctant to reveal prescriptions from other practitioners.
Fenwal Inc. (Lake Zurich, IL) announced that FDA cleared its Verax Platelet PGD test as a quality-control test to detect bacterial contamination in whole blood–derived, pooled platelets prior to transfusion. The Verax Platelet PGD test is the only rapid diagnostic test to receive FDA clearance for detecting bacteria in both pooled and single-donor platelets. The test can be performed in approximately 30 minutes and is designed for use in hospitals, cancer centers, and other sites of care as a safeguard prior to transfusion.
Inverness Medical Innovations (Waltham, MA) launched the Panbio Dengue Early Rapid immunochromatographic test for the early detection of dengue infection. Designed for use in conjunction with other dengue serology tests, the Dengue Early Rapid test can help to diagnose active dengue infection from the very first day fever appears. In facilitating early diagnosis, therapy and monitoring can begin much earlier, reducing the risk of severe complications such as dengue hemorrhagic fever and dengue shock syndrome.
Magellan Biosciences Inc. (Cleveland) became the first company to offer minocycline and telavancin on IVD-labeled microbroth dilution susceptibility plates. FDA cleared the Trek-brand Sensititre MIC plates for testing minocycline against Gram-positive and Gram-negative bacterial isolates, as well as telavancin against Gram-positive bacterial isolates and fastidious Streptococcus sp. isolates. FDA also broadened the tigecycline clearance on the Sensititre platform to include Streptococcus pneumonia testing.
Mtm laboratories (Heidelberg, Germany) launched CINtec Plus, a next-generation cervical cancer testing product for screening and managing cervical cancer. CINtec Plus combines the p16 biomarker, widely validated for diagnostic purposes, with the proliferation marker Ki-67. By combining these two markers in a single diagnostic test, CINtec Plus provides both high sensitivity and high specificity for detecting high-grade cervical disease. The performance of this test for highly accurate detection of pre-cancerous cervical lesions has been demonstrated in three clinical trials conducted in more than 30,000 women across Europe.
|The CoaguChek XS Pro system by Roche Diagnostics.|
Ortho Clinical Diagnostics (Raritan, NJ) announced FDA approval of a diagnostic assay for the detection of antibodies to HIV types 1+2 (Anti-HIV 1+2) for use on the Vitros 5600 Integrated and Vitros 3600 Immunodiagnostic Systems. The Vitros Anti-HIV 1+2 Assay is an immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma. This is the first HIV diagnostic assay approved for an integrated system in the United States, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.
Ortho Clinical Diagnostics also announced FDA approval of the Vitros Hepatitis B Surface Antigen (HBsAg) Assay for use on the Vitros 5600 Integrated and Vitros 3600 Immunodiagnostic Systems. The Vitros HBsAg Assay is an immunoassay for the qualitative detection of hepatitis B surface antigen in human serum and plasma. This diagnostic assay enables the consolidation of hepatitis B testing with routine assays on the Vitros 5600 Integrated System, which will help to make labs more efficient in delivering quality results to physicians and patients.
Randox Laboratories developed a multimarker drugs-of-abuse testing procedure for rapid drug screening programs. The drugs-of-abuse biochips permit the analysis of up to 10 drug classes from a single patient sample, providing rapid and accurate testing. The Randox biochip array technology is based on ELISA methods. Each 9 × 9–mm biochip comprises up to 25 discrete test regions on which immobilized antibodies specific to each biomarker are contained. In addition, two discrete test regions are reserved for quality-control testing.
Randox also developed three biochip arrays for the detection of a variety of antimicrobial agents: Antimicrobial Array I tests for sulphonamides, Array II for general antibiotics, and Array III for nitrofurans, chloramphenicol and malachite green. These arrays enable simultaneous multi-analyte testing of up to 12 antimicrobials from a single sample.
Roche Diagnostics announced that FDA granted premarket approval for its Elecsys Antibody to hepatitis C virus (anti-HCV) assay. The Elecsys Anti-HCV assay is an IVD test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma.
|The Access Sex Hormone Binding Globulin (SHBG) assay by Beckman Coulter.|
Currently pending FDA 510(k) clearance, the Elecsys Anti-HAV IgM immunoassay by Roche is intended for the qualitative determination of IgM antibodies to the hepatitis A virus in human serum and plasma. Used as an aid to detect an acute or recently acquired hepatitis A virus infection, the electrochemiluminescence immunoassay is intended for use on four immunoassay platforms: the Elecsys 2010, Modular Analytics E 170, cobas e 601, and cobas e 411 analyzers.
Siemens Healthcare Diagnostics launched the Emit 2000 Sirolimus Assay for use on the Viva-E and V-Twin Drug Testing Systems. This launch expands the comprehensive menu of immunosuppressive drug monitoring tests available on Siemens’s dedicated drug testing systems including sirolimus, cyclosporine A, tacrolimus, and mycophenolic acid, helping clinical laboratories further consolidate testing and increase operational efficiency.
Siemens also introduced the Innovance Antithrombin assay kit featuring ready-to-use, all-liquid reagents and a human factor Xa substrate to offer higher levels of sensitivity in the diagnosis of antithrombin deficiencies. The chromogenic, automated Innovance Antithrombin test is designed for use on Siemens BCS/BCS XP and Sysmex CA-500 Series, CA-1500, and CA-7000 Systems.
In addition, Siemens received FDA approval for its hepatitis B tests on the Advia Centaur CP System. With that approval, Siemens offers a comprehensive panel of FDA-approved hepatitis A, B, and C assays (including the acute hepatitis test panel) on the Advia Centaur CP immunoassay system, which follows recent FDA approval of the HBc Total and HBc IgM assays for use on the Advia Centaur CP System in the United States.
According to Sha-Sha Wang, PhD, associate director, diagnostics development at Novartis Molecular Diagnostics (Cambridge, MA), “During the past 10 years, the application of molecular tests in infectious disease was the main driver of molecular diagnostics. But during the past few years, especially this past year, molecular diagnostic applications in oncology, personalized medicine, genetic disease, and many new areas are rapidly growing and going beyond infectious disease testing.
|The Evidence Evolution by Randox Laboratories Ltd. (Antrim, UK).|
“Due to the significant unmet clinical needs and the recent varieties of innovative technologies available to the pharmaceutical and IVD industries, I believe more molecular tests in pharmacogenomics and companion diagnostics will soon emerge into the mainstream of molecular diagnostics during the next few years. In terms of technologies and platforms applied to molecular diagnostics test, the current polymerase chain reaction (PCR) and other amplification technologies will still be the main players. But other emerging technologies, such as nonamplified probe-based assays, microarrays, DNA sequencing, DNA methylation assays, and other multiplex technologies, will be growing rapidly, and more molecular tests and technologies are moving toward automation.”
AdvanDx (Woburn, MA) has received FDA 510(k) clearance for a 90-minute protocol for its C. albicans PNA FISH and C. albicans/C. glabrata PNA FISH tests. The faster protocol reduces the PNA FISH turnaround time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the United States demonstrated 100% agreement between the 90-minute protocol, the original PNA FISH protocol, and conventional identification methods, ensuring the faster protocol maintains the high sensitivity and specificity required versus slower, conventional methods.
BD Diagnostics received 510(k) clearance from FDA to market the BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAX System. The BD MAX GBS assay on the BD MAX System represents an advance in neonatal healthcare by streamlining the GBS screening process and addressing the limitations of current culture methods by providing rapid, objective results. With no visual interpretation required, the BD MAX GBS assay identifies GBS in about an hour from Lim broth, which can help to ensure that colonization status is available in the case of preterm delivery.
Beckman Coulter Genomics (Danvers, MA) announced the development of a new version of the DNAdvance System for use with DNA Genotek’s Oragene•DNA samples. DNAdvance SP is an extraction kit for the isolation and purification of DNA from saliva samples collected with DNA Genotek’s Oragene•DNA Self Collection Kits. The high-throughput genomic DNA isolation reagent system enables the purification of high-quality DNA from saliva samples, making it ideal for genotyping applications (SNP, fragment analysis), sequencing, and qPCR. The system provides researchers and laboratories with an optimized and robust solution for DNA extraction and purification from saliva collected with Oragene•DNA Self Collection Kits.
BioMérieux launched NucliSens EasyQ MRSA, a new automated test for Methicillin Resistant Staphylococcus aureus (MRSA). NucliSens EasyQ MRSA detects seven MRSA types, covering the most prevalent strains. The simultaneous detection of two targets, reducing the risk of a falsely positive result, improves specificity and avoids retesting, inappropriate antibiotic treatment, and isolation of patients. The test provides rapid results, with a turnaround time of less than three hours, and the flexibility of being used for batch (46 tests) or stand-alone (one test) screening.
|The QIAsymphony RGQ by Qiagen NV (Venlo, The Netherlands).|
DermaGenoma Inc. (Irvine, CA) released the HerpesDX Genetic Test for frequent genital herpes. The new screening test will help doctors assess patients’ risk for developing frequent genital herpes outbreaks. The HerpesDX test reports on the presence or absence of specific mutations in the mannose-binding lectin gene, which has an important role in the immune response to infection.
Gen-Probe Inc. (San Diego) announced that FDA cleared for marketing Prodesse’s ProFast+ assay, making it the only FDA-cleared molecular diagnostic test to detect and differentiate simultaneously three common influenza A virus subtypes: seasonal A/H1, seasonal A/H3, and 2009 H1N1. The ProFast+ assay is a multiplex, real-time PCR test that detects influenza A from nasopharyngeal swabs. It uses the same internal control and format as other FDA-cleared Prodesse tests for respiratory infectious diseases and integrates into a laboratory’s existing workflow. Test results can be obtained in as little as four hours using the ProFast+ assay.
Greiner Bio-One GmbH (Frickenhausen, Germany) launched two variants of a specially adapted DNA Extraction Kit for its cervical (cervix uteri) cancer test system, PapilloCheck. The support product portfolio for PapilloCheck has been expanded to include two new components: two DNA Extraction Kits certified as CE-IVD suitable for isolating human and viral DNA. These kits were specially developed for extraction of the DNA from uterine cervix smears for subsequent analysis with PapilloCheck.
Luminex and High Throughput Genomics Inc. (HTG; Tucson, AZ) launched a new custom gene expression product, the qBead Gene Expression Assay (qBead Assay). The new qBead Assay places HTG’s qNPA chemistry on the Luminex xMAP Technology multiplexing platform. The result is a high-throughput assay with a simplified workflow that requires no extractions, cDNA synthesis, or amplifications. The qBead assay is suited for scientists who need to get high-quality gene expression data from degraded samples or difficult samples such as formalin-fixed, paraffin-embedded, and other fixed tissues in which RNA quality is an issue.
Luminex also received 510(k) clearance from FDA for a new cystic fibrosis (CF) test, the xTAG Cystic Fibrosis 39 Kit v2. Designed with years of feedback from clinicians and technicians, the xTAG test detects 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF-causing gene mutations, and as an aid in newborn screening and confirmatory diagnostic testing in newborns and children. The xTAG Cystic Fibrosis 39 Kit v2 offers physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations.
|Beckman Coulter expanded its drugs-of-abuse test menu to include a Buprenorphine Enzyme Immunoassay.|
Myriad Genetics Inc. (Salt Lake City) launched Prolaris, a 46-gene prognostic test that quantitatively determines the risk of recurrence in patients who have undergone prostatectomy surgery. Prolaris is a molecular diagnostic assay that offers urologists a more accurate way of determining a prostate cancer patient’s risk of recurrence. The new molecular diagnostic test is based on cell growth and tumor biology, and provides rigorous, quantitative measures of the expression levels of multiple genes related to progression of the cell cycle.
Qiagen launched its highly flexible automated solution QIAsymphony RGQ. This integrated system sets new standards for molecular testing and incorporates all workflow steps from sample to detection. QIAsymphony offers many features that create flexibility, such as continuous-loading, random-access, open channels for user-developed tests; a broad menu of commercial assays; and the ability to process a range of sample types. QIAsymphony provides laboratories with a system that transforms their work in molecular diagnostics.
Roche Molecular Diagnostics Inc. (Pleasanton, CA) announced that FDA cleared its LightCycler MRSA Advanced Test for the detection of MRSA for clinical use in the United States. The LightCycler MRSA Advanced Test is a qualitative test for the direct detection of nasal colonization with bacterial MRSA, and it is designed to aid in the prevention and control of MRSA infections in healthcare settings. Roche’s new real-time PCR test delivers rapid results in two hours and appears to have better sensitivity compared to direct culture–based methods.
Roche Molecular Diagnostics also announced that FDA approved an additional intended use for its licensed nucleic acid test to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative test for the simultaneous, direct detection of HIV (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA, and hepatitis B virus DNA in human plasma.
In addition, Roche Molecular Diagnostics announced that FDA approved its dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient’s blood. The Cobas AmpliPrep/Cobas TaqMan HIV-1 Test v2.0 is the first quantitative viral load test to amplify and detect two separate regions of a target genome and offers a fully automated and reliable solution for physicians to make informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.
Seegene Inc. (Seoul) introduced the Anyplex MDR-TB Screening Test, the first real-time PCR molecular diagnostic capable of simultaneous detection in four hours of TB and genetic mutations leading to multidrug-resistant TB (MDR-TB). Using the AnyplexTM MDR-TB Screening Test, healthcare workers will be able to determine quickly whether a patient is infected with a strain of TB that is resistant to INH and Rif.
Seegene also announced the availability of Magicplex Sepsis Test, a new multipathogen screening test capable of quick and accurate identification of more than 90 leading sepsis-causing pathogens. Magicplex Sepsis provides a fast-acting diagnostic technique for hospitals to verify simultaneously a complex range of targets that indicate sepsis. The speed, accuracy, and price of the Magicplex Sepsis Test will enable doctors and clinicians to provide quickly an appropriate treatment to head off the deadly disease.
In addition, Seegene unveiled a technology called READ (Real Amplicon Detection) that marks a significant departure with current PCR techniques. It enables a new class of powerful molecular diagnostic tests with greater precision. A departure from probe- and primer-based real-time PCR methods, READ PCR uses a new method of real-time PCR called dual-signal generation that works in a two-step process: specifically amplify the DNA sequences of multiple target pathogens, and then read those signals using real-time PCR instruments.
Siemens Healthcare Diagnostics received CE-marking for the Versant CT/GC DNA 1.0 Assay (kPCR). A nucleic acid amplification test, the Versant CT/GC assay provides a sensitive, noninvasive means to detect CT and NG using easy-to-obtain specimens. The Versant CT/GC DNA 1.0 Assay (kPCR) uses nucleic acid amplification to detect plasmid DNA isolated from CT and genomic DNA from NG. Siemens proprietary nucleic acid extraction method results in high DNA target recovery and high efficiency of target amplification. The assay technology is able to detect the presence of CT and NG within both symptomatic and asymptomatic individuals using female endocervical swabs, male urethral swabs, and male or female urine specimens.
With new molecular products on the market, an increased demand for instruments with greater automation and connectivity, and ever-increasing opportunities for bringing POC tests for various samples to market, it has been a positive year for IVD manufacturers, under the circumstances. In addition to smaller, less expensive, faster, and more-accurate traditional IVDs, IVD manufacturers have continued to develop new tests that are tied to pharmaceuticals. More of these companion diagnostics for personalized medicine 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.