NEW TECHNOLOGY
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bioMérieux Inc.: The NucliSens easyMag system is an automated sample-preparation platform for the extraction of nucleic acid in molecular diagnostic assays.
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In June, the U.S. Supreme Court dismissed the patent infringement case of Laboratory Corp. of America v. Metabolite Laboratories. The Court declined to rule on whether the granting of a patent can establish a monopoly over a basic scientific relationship used in medical diagnosis if the claim is limited to correlating test results.
And, in what is the biggest news to come out of the IVD industry, Siemens Medical Solutions (Malvern, PA) acquired both Diagnostic Products Corp. (Los Angeles) and Bayer Diagnostics (Tarrytown, NY) within a couple of months. With these acquisitions, Siemens has become the second-largest developer of immunoassays and one of the biggest IVD companies in the world.
It may be a while before these reimbursement, legal, and business developments take 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
In the instrumentation and automation arena, IVD manufacturers have been responding to demands by laboratories for greater productivity requirements, in which a higher throughput of test results must be obtained with fewer analysts. Labs are also interested in expanding the menu of tests available on instrument platforms, which adds to the complexity of the hardware and software that is required to meet such challenges.
In addition, laboratories are interested in reducing the size of the instruments needed to perform automated tests. This presents enormous challenges for IVD manufacturers, since sample throughput and assay sensitivity are the immediate casualties when testing platforms are scaled down in size. While the new technologies being developed to meet this challenge (e.g., microfluidic systems, electronic detection systems, solid-state amplification in addressable arrays, lateral-flow devices) have been promising, none have emerged to provide all of the performance requirements needed. During the upcoming year, manufacturers should begin beta testing the second generation of automated platforms running with improved assay chemistries.
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Abbott Diagnostics: The Cell-Dyn Ruby is an automated, mid-volume hematology instrument that offers enhanced cellular analysis and greater efficiency for laboratories performing complete blood counts.
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Abbott Diagnostics (Abbott Park, IL) received 510(k) clearance from FDA for its Cell-Dyn Ruby, an automated, mid-volume hematology instrument. With its advanced laser optics, this instrument offers enhanced cellular analysis and greater efficiency for laboratories performing complete blood counts (CBC). A key facet of Cell-Dyn Ruby is its use of laser light to differentiate cellular components. Known as multi-angle polarized scatter separation, this all-optical technology provides detailed results in easy-to-view diagrams, visually depicting changes in white blood cells, red blood cells, and platelets. To streamline inventory and simplify lab operations, Cell-Dyn Ruby only requires four reagents. In addition, this instrument utilizes advanced yet intuitive software with online tutorials to help facilitate training.
Bayer Diagnostics (Tarrytown, NY) introduced its Advia Centaur CP immunoassay system. This compact, benchtop, fully automated analytical system enables hospital and reference laboratories to rapidly perform a wide variety of disease-specific tests that enhance the management of disease. The Advia Centaur CP uses the same proven assay methodologies and reagent packs as the Advia Centaur immunoassay system. The complete menu of disease state assay groups available on both systems includes cardiovascular, oncology, fertility, and infectious disease testing capabilities.
Beckman Coulter Inc. (Fullerton, CA) released 12 standard configurations of its LH 1500– series hematology automation systems. Previously available only as a custom system, the LH 1500–series helps high-volume laboratories manage all hematology testing processes, including pre-analytical sorting, testing, and analysis of results, and postanalytical storage. The standardized configurations simplify system ordering, delivery, and installation for labs. All configurations include sample tracking, sorting, automated cassette loading and unloading, and automatic repeat and reflex testing capabilities. The systems manage rerun and reflex testing requirements without operator intervention, based on programmable decision rules such as age, gender, physician, location, and other criteria.
Biosite Inc. (San Diego) introduced its Triage MeterPro, a portable, rapid testing platform designed to provide rapid, quantitative or qualitative results for immunoassays using urine, whole blood, or plasma, and features comprehensive built-in quality control capabilities. Enhancements to the instrument include an alphanumeric keypad, a 75% larger display, backlighting, and faster printing. The Triage MeterPro also features Test Select, which gives healthcare providers the flexibility to customize test menus based on physician preference or patient presentation when using Triage test panels with multiple analytes.
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Dade Behring Inc.: The Viva-Jr drug-testing system is a small countertop analyzer with a broad menu of drugs-of-abuse tests and multiple time-saving operator benefits.
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Dade Behring Inc. (Deerfield, IL) launched the Viva-Jr drug-testing system for the criminal justice and low-volume clinical laboratories. This system is a small countertop analyzer with a broad menu of drugs-of-abuse tests and multiple time-saving operator benefits. It is the only analyzer of its size that has features found in mid- and high-volume drug-testing analyzers. The Viva-Jr system was developed and is manufactured by Vital Scientific NV (Dieren, The Netherlands), a subsidiary of Clinical Data Inc. (Smithfield, RI). Dade Behring is the sole distributor of the instrument.
Dade Behring also launched the Quadriga BeFree infectious disease testing system to the non-U.S. marketplace. The fully automated, high-throughput system is used to screen blood for common infectious diseases such as HIV and hepatitis. It will be used by large, mid- to high-volume blood bank laboratories to screen donated blood prior to it being used for blood transfusions. The Quadriga BeFree has many features that help to make the testing for infectious diseases safe. Such features include the following: automated patient sample handling and verification, automated bar code identification or patient samples, and continuous monitoring of the instrument’s status.
In addition, Dade Behring introduced the BCS XP system, a coagulation analyzer that delivers customer-inspired features resulting from interviews with current BCS system customers. The BCS XP system provides the most current technology in clotting, chromogenic, and immunologic methodologies. Such features include the following: customizable software based on customer protocols to improve laboratory efficiency; an automated ristocetin cofactor activity test that detects von Willebrand’s disease; and simultaneous specialty and routine testing to improve work flow in the lab.
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Roche Diagnostics: The Cobas 6000 analyzer is an integrated clinical chemistry and immunoassay testing platform with a small footprint and an easy-to-use interface.
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Roche Diagnostics (Indianapolis) received FDA clearance for its Cobas 6000 analyzer series. This analyzer provides laboratories with an integrated clinical chemistry and immunoassay testing platform as well as a small footprint and an easy-to-use interface. The Cobas 6000 delivers approximately 95% of a lab’s typical testing mix of more than 130 assays, including substrates, enzymes, electrolytes, therapy drug monitoring, drugs-of-abuse testing, proteins, cardiac markers, thyroid, tumor markers, bone markers, fertility, anemia, and diabetes. This integrated, broad menu streamlines work flow processes and efficiency, running a throughput of up to 1170 tests per hour, including a stat interruption mode that prioritizes stat racks to be sampled within 60 seconds.
The Cobas 6000 can accommodate front-end automation with the modular preanalytics system, eliminating off-line sample preparation and reducing the potential for human error. The analyzer also includes several unique features. The new sample probe can pipette whole blood and provides clot detection and liquid level detection to increase confidence in sample quality. The reaction disk has ultrasonic mixing which reduces maintenance and carryover potential.
Sysmex America Inc. (Mundelein, IL) received FDA clearance for its XS-1000i automated hematology analyzer. This analyzer, which is available both with and without an auto sampler, utilizes fluorescent flow cytometry and advanced cell-counting methods to deliver rapid, reliable test results that are essential in advanced patient diagnosis and therapeutic monitoring. The XS-1000i provides medical lab personnel with discrete hematology testing options for CBC and CBC with five-part differential, utilizing fluorescent flow cytometry for whole blood count analysis and hydrodynamic sheath flow technology for measuring red blood cell and platelet cell counting. Sampling is done in a closed tube environment, assuring operator safety, and the instrument offers 21 testing parameters.
Data and Information Management
The past year has seen significant advances in increased hardware performance for reducing costs. According to Dan Olivier, president of Certified Software Solutions Inc. (San Diego), the recent trends in data and information management are characterized by how IVD manufacturers have been leveraging such increased processing and storage capacity to reduce the time to market for new product development. Other specific trends include the following:
• Establishing partnerships that can accelerate new development through interfaces with partners’ existing hardware systems and by leveraging their existing software functional capabilities and expertise.
• Revising existing design and development procedures by streamlining documentation and using risk-driven practices that allow parallel development and test activities in iterative cycles.
• Enhancing product quality as measured by customer satisfaction. This awareness has increased as a result of greater visibility of the cost of poor market acceptance after product launch and the cost of addressing product failures.
Olivier added that other advances in data and information management during the past year include increased interoperability of IVD systems and the need for improved security and privacy controls. Although FDA’s electronic record and electronic signature regulation has been put on the back burner for the time being (a new version of the regulation is expected to be released in the near future), recognizing the need for security and privacy of data is becoming a core requirement for new IVD systems. Complying with security regulations in the United States (e.g., the Health Insurance Portability and Accountability Act) and Europe (e.g., Safe Harbor) continues to emphasize the need to protect patient health information. Integrating controls for security and data privacy has become a core requirement for all new IVD developments and for retrofitting many existing diagnostic applications.
Beckman Coulter introduced DL2000 Data Manager v6.5. When paired with an optional database server, this software delivers a significantly increased real-time data storage capability to archive up to 500,000 patient sample records. With hematology graphics, the database stores up to 300,000 records. This storage size enables larger labs to archive more results for instant recall and comparison. The new v6.5 also offers a hematology slide bar code scanning capability for labs with a client review station. With this new function and optional handheld scanner, the patient sample bar code can be scanned right at the manual differential station, for error reduction and faster recall.
bioMérieux Inc. (Marcy l’Etoile, France) released ENQ, an advanced multiprotocol laboratory interface management system to resolve compatibility problems between bioMérieux diagnostic instruments and hospital laboratory information systems. The system features smart auto-protocol generation that simplifies the process of adding new instruments to the lab. The ENQ interfacing system offers smart features that process data and provide intelligent feedback to assist the lab technician. Such features include data collection and processing, reporting to support hospital compliance and analysis, and traceability of data and snapshot views of transmissions.
LifeScan Inc. (Milpitas, CA) introduced OneTouch DataLink Wireless and OneTouch DataLink Web, which are designed for fast, reliable, and secure transfer of blood glucose data between point-of-care and the central laboratory. OneTouch DataLink Wireless supports wireless communications between OneTouch Flexx Meters and OneTouch DataLink workstations to enhance decisions, streamline processes, and help to improve work flow. Using single-point control, OneTouch DataLink Web features thin client-server technology for greater control, flexibility, and cost-efficiency.
Ortho-Clinical Diagnostics Inc. (Raritan, NJ) issued software version 1.02 for the Ortho AutoVue Innova and Ultra systems. This software ensures system performance in the areas of safety, integrity of results, and operational efficiency. The software version 1.02 offers the following features: safety and security, higher first-pass yield, higher productivity and efficiency, optimized interface to Ortho Resolvigen software, and cost-effectiveness.
Point-of-Care Devices
In the point-of-care (POC) testing segment, a huge emphasis has been placed on connectivity, and a consequent reinterpretation of what POC testing can mean. According to Brendan O’Farrell, PhD, principal at Diagnostic Consulting Network (Carlsbad, CA), with appropriate POC testing technologies and improved connectivity, it is becoming more likely that there may be less emphasis on data interpretation at the point of care. With appropriate application, data can be generated at the point of care and sent to a centralized location for evaluation and interpretation, with the results sent back to the point of care for transduction to immediate action. This methodology lends itself to database maintenance and data mining in ways that have not been previously possible or even considered in many clinical and nonclinical point-of-care applications.
O’Farrell added that this methodology may also lend itself to ways to impose higher-quality standards at the point of care for technologies such as lateral flow. For example, if centralized data analysis is being used, the results of quantitative tests performed at a given site on a given lot of samples can be compared immediately to results generated on that lot of samples at different times and locations. Incorrect results can be easily identified, and a retest can be ordered.
Abbott Point of Care (East Windsor, NJ) received 510(k) clearance from FDA to market its i-Stat Chem 8+ cartridge, a new POC diagnostic test used to quickly assess basic metabolic status of patients in emergency rooms, clinics, surgical suites, and other critical-care settings. The cartridge combines a battery of basic metabolic tests, including sodium, potassium, chloride, ionized calcium, total CO2, glucose, blood urea nitrogen, and creatinine, with measurements for hematocrit and hemoglobin into a single test. The cartridge provides a rapid snapshot of the most critical homeostasis processes: glycemic control, electrolyte balance, and renal function, right at the patient’s beside and using just a few drops of blood.
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International Technidyne Corp.: The ProTime microcoagulation system is used in the management of patients treated with oral anticoagulants.
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International Technidyne Corp. (Edison, NJ) introduced a new version of its ProTime microcoagulation system for use in the management of patients treated with oral anticoagulants. The new system has several new instrument and software features designed to enhance user ease and convenience, increase results-reporting efficiency, improve safety, and reduce transcription errors. The software has been updated to include the ability to send results automatically to a printer or computer. Results can also be transmitted to a laboratory information system or electronic medical record database through a clinical interface. The new system also accepts and stores patient and/or operator identification for reducing transcription errors. The off-meter sampling feature provides safety against possible sample contamination and disease transmission.
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Nova Biomedical: The Nova StatStrip is a blood glucose monitoring system that incorporates new four-well glucose measuring strip technology.
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Nova Biomedical (Waltham, MA) released its Nova StatStrip blood glucose monitoring system that incorporates new four-well glucose measuring strip technology. This device uses Nova’s Multi-Well system, which measures and corrects hematocrit interferences as well as interferences from acetaminophen, uric acid, ascorbic acid, maltose, galactose, xylose, and lactose. StatStrip also eliminates oxygen interference to provide accurate glucose results regardless of the sample’s oxygen status. In addition, these strips require no calibration coding.
Roche Diagnostics submitted its CoaguChek XS system for 510(k) clearance to FDA. This instrument will provide healthcare professionals with a new testing option for in-office prothrombin time/INR testing. The system provides fast results in approximately 1 minute and requires only one drop of blood from the fingertip. The innovative test strip was designed with built-in controls, which it reads to determine strip integrity. The strips can be dosed on the top, right side, or left side, making it easier for patients to apply blood.
Immunoassays
Regarding new trends in immunoassays, the discussion often heard these days in the IVD industry is an interest in multiplexing. According to Eileen Skaletsky, PhD, president and CEO at QED Bioscience Inc. (San Diego), multiplexing has been a logical follow-up to microarray technologies that have been in place for a while. The ability to evaluate one sample in one test for the presence or absence of multiple analytes is very appealing. However, multiplexing immunoassays presents some challenges. For example, the need to optimize and coordinate the activities of multiple antibodies simultaneously can be extremely difficult. Many multiplex assay systems also require a pair of antibodies to detect a particular analyte, adding yet another layer of difficulty. In addition, considering that some clinical samples (e.g., whole blood) contain interfering factors, IVD manufacturers have a multilayered puzzle to solve.
Skaletsky added that multiplex assay systems will probably be automated, so the challenges inherent in parallel instrument development cannot be ignored. Like most other high-tech products, reliable and reproducible multiplex assay systems should be very simple for end-users but represent major investments and technological accomplishments by IVD manufacturers. Furthermore, as the IVD industry explores opportunities in personalized medicine, there will be increasing interest in multiplex immunoassays that help define a patient’s medical profile.
Abbott Diagnostics received FDA approval for its Prism hepatitis B surface antigen (HBsAg) and its Prism HBsAg confirmatory test. These tests can be used by laboratory technicians to screen donated blood for HBsAg. The company has submitted premarket approval (PMA) applications with FDA for a hepatitis anti-HBs test and an anti–hepatitis C virus test for its Architect automated immunoassay instrument system, and a hepatitis HBsAg confirmatory test for its AxSym instrument.
American Diagnostica Inc. (Stamford, CT) introduced its Acticlot Protein C Resistance assay to complement its special coagulation product line. This test is a clot-based assay for determining the presence of the Factor V Leiden mutation. In clinical studies, this assay demonstrated 100% specificity and 100% sensitivity. Major advantages of this test are its simplicity in design and use, and the ability to distinguish homozygous, heterozygous Factor V Leiden carriers and wild type individuals. Unlike other coagulation-based assays, this assay is not affected by most blood factor deficiencies, inhibitors, or lupus anticoagulants.
American Diagnostica also received 510(k) clearance from FDA for its Acticlot dPT test for detecting lupus anticoagulants. This test is the first commercially available dilute prothrombin time test and is a significant advance in the diagnosis of antiphospholipid syndrome.
Bayer Diagnostics announced the availability of its TnI-Ultra troponin assay on the Advia Centaur CP immunoassay system. The company has received FDA clearance for two other troponin-I assays: the Advia IMS and Advia Centaur TnI-Ultra assays. The TnI-Ultra assays aid physicians in diagnosing myocardial infarction and assessing the risk in patients with acute coronary syndrome. The assays are the first fully automated troponin assays meeting the European Society of Cardiology and American College of Cardiology recommendations of a less than 10% level of imprecision at the 99th percentile of a healthy population.
Bayer released two new therapeutic drug monitoring assays, lithium and vancomycin, on its Advia 1650, Advia 2400, and Advia 1200 chemistry systems. The lithium assay is used to monitor a patient’s level of lithium, and the vancomycin method is used to monitor the level of vancomycin. The company also announced the availability of immunoglobulin tests of IgA, IgG, and IgM, and drugs-of-abuse tests on the Advia 1200. In addition, Bayer received FDA approval for the first fully automated test for antibodies for human immunodeficiency virus called EHIV. This assay is used for the qualitative determination of antibodies to HIV-1, HIV-2, and HIV-1 subtype O in human serum and plasma.
Beckman Coulter expanded the thyroid menu on its Access family of immunoassay systems by releasing an assay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma. This new assay enables rapid, accurate reporting of TPOAb results that aid in the diagnosis of autoimmune thyroid disease. This test can be performed using serum or heparinized plasma and requires a sample volume of only 10 µl. This assay delivers results in approximately 30 minutes and offers 56-day calibration and open-pack stability.
bioMérieux developed an advanced colorimetry NH card for the Vitek 2, which will provide an accurate, rapid, and automated method for identifying Neisseria species, Haemophilus species, and other fastidious species. The 64-well card contains 30 biochemical tests and features a database comprised of 28 taxa of clinical and industrial significance.
Chembio Diagnostics Inc. (Medford, NY) received an approvable letter from FDA for the PMAs filed for its Sure Check HIV 1/2 and HIV 1/2 Stat-Pak rapid test. These rapid tests detect HIV-1 and HIV-2 antibodies in four different sample matrices: fingerstick whole blood, venous whole blood, serum, and plasma. Test results are complete within approximately 15 minutes of sample application. The FDA letter stated that Chembio’s PMA is subject only to final review by FDA of the package inserts for each of the products, and other standard conditions related to all PMAs.
Chiron Corp. (Emeryville, CA) obtained FDA approval for its Procleix West Nile virus (WNV) assay to screen whole blood donations for use on the Procleix system. Developed in collaboration with Gen-Probe Inc. (San Diego), the assay has been used to screen more than 29 million units of blood on an investigational-use-only basis since June 2003, and has intercepted more than 1500 WNV-positive donations.
Clinical Data Inc. (Newton, MA) received 510(k) clearance from FDA to market the Nanopia wrCRP assay. This test is used for the quantitative measurement of C-reactive protein in serum or plasma. This assay was developed by Daiichi Pure Chemicals Co. (Tokyo).
Dade Behring launched the Tacrolimus test for use on its Dimension family of chemistry analyzers and V-Twin and Viva-E drug-testing analyzers. This test expands the company’s offering of immunosuppressant drug tests used by physicians to monitor organ rejection in patients who have recently received an organ transplant. Earlier, the company released the Cyclosporine Extended Range test for use on these same systems. This test allows cyclosporine to be monitored within 2 hours of patients ingesting the drug.
Dade Behring introduced the cardiac-specific CardioPhase hsCRP test on its Dimension systems. This test has been cleared by FDA for both risk assessment of future cardiovascular disease and risk stratification for the prognosis of recurrent events. The company also launched an automated ecstasy test on its Dimension analyzers. In addition, Dade Behring received FDA clearance for its Stratus CS Acute Care D-dimer assay as an aid in diagnosing venous thromboembolism. The clearance included performance data with a defined cutoff value for this method on the Stratus CS system.
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Diagnostic Chemicals Ltd.: This two-part liquid-stable microalbumin assay for the quantitative determination of the analyte in urine received 510(k) clearance from FDA.
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Diagnostic Chemicals Ltd. (Oxford, CT) received 510(k) clearance from FDA for its two-part liquid-stable microalbumin assay for the quantitative determination of the analyte in urine. This assay employs an immunoturbidimetric test method, while offering exemplary performance characteristics with regard to accuracy, precision, and linearity. Optimized for use on a variety of instrument platforms, this assay is suited for use with fully automated testing procedures, with an extensive listing of applications readily available.
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DiaSorin Inc.: The Liaison toxoplasma gondii assays including toxoplasma IgG and toxoplasma IgM obtained FDA clearance.
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DiaSorin Inc. (Stillwater, MN) obtained FDA clearance for its Liaison toxoplasma gondii assays including toxoplasma IgG and toxoplasma IgM. With these assays, the company has expanded the infectious disease testing menu on its Liaison system, an automated, random-access chemiluminescent analyzer.
Inverness Medical Innovations Inc. (Waltham, MA) introduced its Clearview Exact Influenza A&B, a rapid, simple, and accurate test to detect influenza A&B viral antigens. The test is an immunochromatographic membrane assay that utilizes sandwich immunoassay technology. The test consists of a dipstick device containing a membrane strip that has separate regions with immobilized influenza A and B–specific monoclonal antibodies and a colored gold conjugate that also consists of specific influenza A and B antibodies.
Meridian Bioscience Inc. (Cincinnati) received FDA clearance to market its Premier Platinum HpSA Plus, a new test for the diagnosis of Helicobacter pylori infection. This test is simple and provides accurate results from a noninvasive patient sample. This test uses patented technology similar to that used in Meridian’s Premier Platinum HpSA test, and its use is also indicated in monitoring patient response to therapy.
Nanogen Inc. (San Diego) obtained 510(k) clearance from FDA to market its StatusFirst CHF NT-proBNP EDTA plasma test to aid in the diagnosis of individuals suspected of having congestive heart failure (CHF). This test results from a collaboration between Nanogen and Princeton BioMeditech Corp. (PBM; Princeton, NJ). Nanogen and PBM have codeveloped and will comarket the product. PBM will manufacture the product under contract with Nanogen.
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Ortho-Clinical Diagnostics: The Vitros NT-proBNP immunoassay quantitatively measures N-terminal pro brain natriueretic peptides.
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Ortho-Clinical Diagnostics received FDA clearance for its Vitros NT-proBNP immunoassay, which quantitatively measures N-terminal pro brain natriueretic peptides. This assay provides advanced testing capabilities to aid in diagnosing CHF, risk stratification of acute coronary syndrome and CHF, and in assessing increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary disease. The test can also be used in assessing heart failure severity in patients diagnosed with CHF.
Ortho-Clinical Diagnostics released its Vitros chemistry products d%A1c reagent, which is used in the management of patients with diabetes. This assay is fully automated, eliminating manual sample preparation and thus expediting test reporting. With its high specificity, it can be used in patient samples with the most common hemoglobin variants. The company also introduced its Vitros chemistry products dTIBC reagent, which is used to measure quantitatively total iron-binding capacity in human serum. In addition, Ortho-Clinical Diagnostics released two new MicroTip assays: antistreptolysin O (ASO) and alpha-1 antitrypsin (AAT). The ASO assay is used to diagnose poststreptococcal diseases, and the AAT assay aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Ortho-Clinical Diagnostics received 510(k) clearance from FDA for its CA 19-9 assay for use on the Vitros Eci and EciQ immunodiagnostic systems. This assay quantitatively measures the 1116-NS-19-9 defined antigen in human serum or plasma. The company also released its Vitros chemistry products dHDL slide. The slides are used to measure quantitatively HDL cholesterol (HDLC) concentration in serum and plasma. The slide is a rapid, completely automated random-access test, which requires no sample pretreatment. Test results are available in less than 6 minutes, and the test is performed in a single step versus traditional dHDL assays that require multiple steps. The unique slide structure features three separate mechanisms to improve HDLC specificity. The slide assay is certified by the CDC lipid standardization program for manufacturers.
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Oxford Immunotec Ltd.: The T-Spot.TB 8 is used for the diagnosis of latent tuberculosis infection and active TB disease.
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Oxford Immunotec Ltd. (Oxford, UK) launched a second generation product, T-Spot.TB 8, for the diagnosis of latent tuberculosis infection and active TB disease. The launch of this product culminated a 15-month codevelopment program with Millipore Corp. (Billerica, MA) to develop a proprietary plate for performing the T-Spot.TB test. This plate allows the test to be conducted in lower batch sizes when smaller numbers of tests need to be performed simultaneously as the plate consists of several eight-well strips, which can be used individually.
Response Biomedical Corp. (Vancouver, BC, Canada) initiated commercialization of its Ramp Flu A test, a new high-sensitivity rapid test for detecting influenza A. Given the positive initial results of the Ramp Flu A test, numerous leading international public health authorities are expressing interest in evaluating this test for detecting avian flu.
Roche Diagnostics announced the availability of its new Elecsys Prolactin II assay for the quantitative determination of prolactin. The enhanced Prolactin II assay provides laboratories with an additional benchmark for macroprolactin recognition by using new antibodies with very low activity against most forms of macroprolactin. Earlier, Roche received FDA clearance for its Elecsys N-MID Osteocalcin immunoassay, which is used for the quantitative determination of osteocalcin.
In the cardiac testing area, Roche obtained FDA clearance for its Elecsys proBNP test. This assay is the only natriuretic peptide test to receive FDA approval for the risk assessment of cardiac events in people with stable coronary artery disease. Roche also announced the availability of its heparin-compatible Elecsys troponin T Stat and troponin T assays. The heparin sample flexibility provides reduction in pre-analytical time for laboratories.
Molecular Diagnostics
The molecular diagnostics field has been very active, and the activity in this field will increase exponentially during the coming years. According to Amit Kumar, president and CEO at CombiMatrix Corp. (Mukilteo, WA), one continuing trend is that many of the molecular diagnostics on the market are home-brew products that are not directly regulated by FDA. However, FDA has requested meetings with several companies that have launched or are launching molecular diagnostics in order to keep up to speed on emerging technologies. Another continuing trend is that virtually all molecular diagnostics today utilize a form of multiplexed polymerase chain reaction (PCR) as the platform technology. However, in late 2006 and into 2007, numerous DNA microarray-based diagnostic products may be launched. While many of these products will be home brews, some will be FDA-approved IVDs.
Another development that could affect the molecular diagnostics industry occurred recently when U.S. Senator Barack Obama (D–IL) proposed the Genomics and Personalized Medicine Act of 2006. The bill would increase funding for research on genomics, expand the genomics workforce, provide a tax credit for the development of diagnostic tests that can improve the safety or effectiveness of drugs, and reaffirm the need to protect genetic privacy. Even though this bill is still at an early stage in the process, any legislation in this area indicates a growing market and interest in molecular diagnostics. While it is not clear whether this bill will become law or what form it will take if it does, the bill will generate a lot of attention to the molecular diagnostics industry and the products being developed. The next 12–18 months will continue to be very active and exciting for the molecular diagnostics industry.
Aureon Laboratories Inc. (Yonkers, NY) launched Prostate Px, an integrated molecular test that can provide patients and their physicians with a personalized determination of their risk for prostate cancer recurrence following removal of the prostate. The physician receives a Prostate Px score for both the probability of PSA recurrence and clinical failure. Along with traditional methods of disease analysis, this test can provide to patients and their caregivers valuable insight when making postoperative therapy decisions such as planning appropriate adjuvant therapy.
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BD Diagnostics: The BD Viper system is a novel, patented approach to laboratory automation using an industrial class of robotics known as selective compliance assembly robot arm.
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BD Diagnostics (Franklin Lakes, NJ) received 510(k) clearance from FDA for its BD Viper system for infectious disease molecular diagnostic testing. This system is a novel, patented approach to laboratory automation using an industrial class of robotics known as selective compliance assembly robot arm (SCARA). Incubations, amplification, and detection all occur on the BD Viper system, with repetitive pipetting labor delegated to the robot. The SCARA robotic approach delivers a robust instrument by eliminating all pumps, syringes, and reagent tubing. The system also uses the proven chemistry of strand displacement amplification that has been embraced by more than 1100 laboratories worldwide.
bioMérieux launched its NucliSens easyMag system, an automated sample-preparation platform for the extraction of nucleic acid in molecular diagnostic assays. This platform offers automated extraction of nucleic acids from clinical samples based on the nucleic acid binding property of silica. By using magnetic silica particles for enhanced automation and by further optimizing the extraction reagents, an even higher quality of extracts can be obtained from a wide variety of sample types. This system offers high throughput automated nucleic acid extraction with minimum hands-on time and a fast turnaround time, allowing up to 240 extractions in an eight-hour shift.
Cepheid (Sunnyvale, CA) received 510(k) clearance from FDA for its Xpert GBS test for group B streptococcus (GBS) on its GeneXpert platform. This test is designed to detect GBS DNA from vaginal or rectal swab specimens, using fully automated real-time PCR with fluorogenic detection of the amplified DNA. The Xpert GBS assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization. This assay includes unique internal controls to help ensure quality of results. A sample-processing control monitors processing conditions; an internal control monitors PCR conditions and the absence of reaction inhibition; and a probe check control verifies reagent rehydration, PCR-tube filling in the cartridge, probe integrity, and dye stability.
Cepheid also introduced the GeneXpert 16-site system, which has the flexibility to run up to 16 different molecular tests simultaneously, with minimal hands-on time, thereby delivering the power of true on-demand testing. This system is configurable from four to 16 modules, allowing users to expand their system as demand for assays increases. The system has full random-access capabilities performing multiple molecular tests simultaneously. The automated software eliminates the need for interpretation by users.
Genzyme Corp. (Cambridge, MA) launched its EGFR mutation assay, a new laboratory test to help identify patients likely to respond to therapies targeted for the treatment of non-small-cell lung cancer (NSCLC). This assay will help to detect the presence of epidermal growth factor receptor (EGFR) mutations in patients with NSCLC. To perform the test, cells from specific tumor-rich areas are microdissected, followed by DNA extraction, PCR amplification, and bidirectional sequencing of exons 18 through 21 in tyrosine kinase domain of the EGFR gene.
Qiagen Hamburg GmbH, a subsidiary of Qiagen NV (Venlo, The Netherlands), received CE marking and certification for its artus CMV PCR kits. These kits assure rapid and quantitative detection of cytomegalovirus (CMV) DNA from EDTA plasma. Due to the same temperature profile for detecting herpes virus DNA with the artus PCR kits, the four herpes viruses (CMV, EBV, VZV, and HSV-1/2) can be detected in parallel in a single run.
Tepnel Life Sciences PLC (Manchester, UK) received approval from the Medical Devices Bureau of Health Canada to sell its Elucigene QST*R in Canada. This test is a prenatal DNA-based diagnostic assay that can rapidly detect common chromosome abnormalities including those responsible for Down syndrome, Edwards’ syndrome, and Patau syndrome. This highly multiplexed assay can be performed on a standard capillary genetic analyzer. The rapid test method is a three-step process comprising DNA extraction, PCR amplification, and analysis. While the Elucigene QST*R has been available as a fully validated and CE-marked product in Europe, the company is making plans to market the product in the United States.
Conclusion
It has been a prosperous year for IVD manufacturers 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. Pending legislation could provide a boost to the emerging area of personalized medicine and encourage diagnostic companies developing products that are tied to theranostics.
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.
Further 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.
