NEW TECHNOLOGIES
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The AutoSorter II by Motoman Inc. (Dayton, OH).
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Earlier this year, another traditional diagnostic imaging company, General Electric Co. (Fairfield, CT), agreed to acquire the primary IVD and point-of-care diagnostics businesses of Abbott (Abbott Park, IL) for $8.13 billion. However, several months later, the two companies were unable to agree on final terms and conditions of the proposed sale, and mutually agreed to terminate their merger agreement.
In May, Beckman Coulter Inc. (Fullerton, CA) lost its bid to acquire Biosite Inc. (San Diego) to Inverness Medical Innovations Inc. (Waltham, MA). Meanwhile, Roche Holding AG (Basel, Switzerland) is still trying to acquire Ventana Medical Systems Inc. (Tucson, AZ) for $3 billion, which Ventana has rejected.
It may be a while before the fallout from these mergers and acquisitions 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 area, more mid-volume labs are installing preanalytic automation solutions, which is a response to not only the labor shortage of qualified medical technologists but also the growth of their own test volumes. Since automation helps to keep labs’ operating costs low and predictable as their volumes grow, IVD manufacturers have been challenged to provide automation solutions that physically fit into these labs with and without major laboratory renovation.
IVD manufacturers have also seen the increasing importance of open connectivity to other analytic systems, especially coagulation and hematology platforms. The main driver of this trend is the laboratory trying to maximize the percentage of specimens handled on an automation line in order to streamline testing procedures and specimen preparation.
According to Joseph Meyer, vice president of marketing for the centralized diagnostics business unit at Roche Diagnostics (Indianapolis), two other key trends have continued to emerge on the analytics front. In larger lab networks, the trend is the requirement to provide standardized results across all sites. Having such standardized results from various analytic platforms that are deployed in the core and satellite labs with similar operating environments allow lab personnel to work in various sites seamlessly.
“In hospitals with mid-volume labs, the key trends are consolidation and integration of testing,” says Meyer. “This means that such hospitals would like to run as much of their testing menu on as few chemistry and immunochemistry integrated platforms as possible to simplify work flow and minimize sending out their tests.”
Abbott Diagnostics introduced the latest Accelerator automation solutions for the Architect immunochemistry analyzer platforms. Accelerator is designed to streamline clinical laboratory process efficiency and improve quality. It offers an online, sample storage unit with a capacity of 15,000 tubes, providing automated sample retrieval and retesting capability. Later this year, Accelerator will be integrated with the company’s Architect 1600 clinical chemistry analyzers.
Abbott Diagnostics also previewed the expanded Architect family of analyzers. Currently approved for sales outside of the United States, the Architect c16000 and the Architect ci16200 will expand the company’s immunoassay and clinical chemistry platform by offering high-volume solutions for large hospitals, reference laboratories, and other larger-volume testing facilities. The Architect ci16200 integrates the clinical chemistry capabilities of the c16000 and the immunoassay capabilities of the i2000SR on one platform, allowing for seamless transfer from system to system with the same compact size and dimensions of the Architect ci8200.
Beckman Coulter Inc. (Fullerton, CA) introduced the Coulter LH 780 hematology system that incorporates advancements to the company’s VCS (volume, conductivity, and scatter) technology for high sensitivity, specificity, and efficiency in whole blood count differential analysis. This system delivers new functionality that increases laboratory capability and helps to reduce healthcare costs. The system offers new parameters including RDW-SD, which measures deviation of the width of the red cell population for applications such as anemia studies.
Beckman Coulter also launched the UniCel DxI 600 Access Immunoassay System, an immunochemistry instrument designed for mid-volume laboratories supporting 200- to 400-bed hospitals. This system processes up to 200 tests per hour and releases the primary tube in less than five minutes. Its features include refrigerated storage for 50-reagent packs and onboard aliquotting. The system can facilitate workstation consolidation and expand laboratory testing to include assays such as the company’s AccuTnI troponin I.
BioTek Instruments (Winooski, VT) developed in partnership with Immucor Inc. (Norcross, GA) the Galileo Echo, an automated benchtop assay instrument for use in the blood transfusion industry. This device provides small- to medium-sized hospital blood bank laboratories with walkaway automation of tests such as ABO grouping and Rh(D) typing, detection and identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping for significant increases in productivity and patient safety.
Dade Behring launched the Dimension Vista 1500 Intelligent Lab System, an ultraintegrated analyzer for high-volume clinical laboratories. Using four advanced detection technologies, this system allows laboratory personnel to perform efficiently a broad range of chemistry and immunochemistry tests on one analyzer. Such tests that the system can run include panels for cardiac disease, thyroid disorders, therapeutic drug monitoring, drugs-of-abuse testing, protein testing, and routine and specialty chemistry testing.
Dade Behring also introduced several enhancements to the StreamLab Analytical Workcell, the company’s scalable automation solution. The new enhancements will assure the opportunity for clinical laboratories to install automation in a smaller space and also take advantage of new capabilities such as connectivity to a new middleware data management solution. StreamLab is designed to evolve with a clinical laboratory’s changing needs, and can connect to not only multiple Dade Behring analyzers but also other selected manufacturers’ systems.
Luminex Corp. (Austin, TX) unveiled FlexMap 3D, a next-generation bead-based multiplexing system. This system will be able to simultaneously measure up to 500 analytes in a single microplate well, and provide improved analytical performance, greater speed, more automation, and a streamlined work flow. In addition to increased multiplexing capabilities, the system will offer a high-throughput module and the ability to interface with liquid handlers for streamlined automation.
Motoman Inc. (Dayton, OH) introduced the AutoSorter III, a compact, full integrated pre- and postclinical specimen-processing platform for the hospital and medical center laboratory environments. Designed to relieve laboratory staff of repetitive tasks, this platform operates independently, providing accurate, reliable specimen sorting, centrifugation, decapping, and postclinical archive consolidation. The platform permits use of a wide variety of specimen tube configurations and instrument racks.
Roche Diagnostics (Indianapolis) released the Cobas e411 analyzer, its next-generation benchtop immunoassay analyzer. This analyzer offers solutions for the low- to mid-volume immunoassay market, and it optimizes operation efficiency by combining fast turnaround time and ease-of-use with the company’s Elecsys system technology. The analyzer provides results for critical assays (e.g., troponin T, CK-MB, myoglobin, and HCG) in as little as nine minutes.
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The Clinitek Advantus urine chemistry analyzer by Siemens Medical Solutions Diagnostics (Tarrytown, NY).
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Siemens Medical Solutions Diagnostics launched the Clinitek Advantus urine chemistry analyzer. The analyzer enables automated reading of the company’s Multisix family of urinalysis testing strips in medium- to high-throughput settings. This semiautomatic analyzer can perform up to 500 tests per hour, is network-ready, and delivers improvements such as the ability to consolidate microscopic test results.
Siemens Medical Solutions also announced the availability of the Advia 1800 chemistry system, which features an intuitive software interface and advanced chemistry testing capabilities to deliver optimized performance and reliable results. This system incorporates automation connectivity to the Advia WorkCell or Advia LabCell network solutions without requiring additional interface hardware. With point-in-space aspiration, connection to a track or rack handler can be accomplished without robotics or special hardware.
Data and Information Management
No longer operating in isolation, IVDs continue to be integrated with multiple information management systems that need access to instrument data. In addition to maintaining a connection to a laboratory information system, devices are often connected to other systems, such as middleware and remote monitoring systems. Middleware systems provide centralized access to features such as test ordering and sample management, allowing customers to optimize sample processing based on their needs. Remote monitoring systems provide improved service and support by IVD manufacturers, resulting in increased instrument uptime for the laboratory.
The need to integrate IVDs with additional systems will continue to grow. One reason for the expected growth is the demand for additional laboratory services such as the following: centralized instrument monitoring; automated quality control peer review; automated consumable ordering, tracking, and billing; and centralized reporting.
Another reason for the growth is that interoperability standards may require increased access to information created or maintained by IVDs. For example, the Healthcare Information and Management Systems Society has an initiative that focuses on the adoption of interoperability for passing healthcare information from system to system. The Healthcare Information Technology Standard Panel is also developing interoperability specifications covering such topics as electronic healthcare records and consumer empowerment over personal health records. The integration of IVDs with additional information management systems may be necessary in order to support efficiently the specifications and standards generated by the activities of such organizations.
Beckman Coulter released the DL2000 Extended Quality Control, a new software module designed for use on the company’s DL2000 Data Manager. This software provides advanced quality control functionality through additional rules and graphic analysis tools to utilize a statistical technique called patient moving averages. The software enables clinical labs to use normal patient test results as an additional monitor of system stability in between quality control runs.
bioMérieux Inc. (Marcy l’Etoile, France) released Observa noninterfaced version 3, a next-generation data management software. This Windows XP platform software consolidates data and results from the automated BacT/Alert 3D microbial detection device. The software offers the convenience of monitoring multiple data from a single workstation. This feature can help to reduce production costs and improve data management. The software will provide blood bank laboratories with 21 CFR Part 11 compliance and audit tracking to improve system security and confidence.
Dade Behring launched the ACC PowerPak package, a performance enhancement tool for the company’s Dimension systems that adds new automated features and allows more hands-off time for clinical laboratory personnel. Such features can automate quality control procedures, streamline daily operation processes, and enhance patient data management capabilities.
Data Innovations Inc. (South Burlington, VT) announced that the Instrument Manager received 510(k) clearance from FDA for use in blood banking environments. FDA designation allows the company to market Instrument Manager v8.05 for use in not only blood banks but also transfusion centers in the United States. Instrument Manager is a comprehensive middleware system for managing laboratory operations, including preanalytical, analytical, and postanalytical sample processing, and nonclinical tasks such as equipment maintenance and specimen archiving.
Roche Diagnostics introduced new firmware and software upgrades for the Cobas b221 blood gas system. The newly introduced v6.0 firmware offers a continuous self-monitoring feature that tracks the status of electrodes, sensors, and consumables, and provides real-time onboard maintenance logs. The firmware also lists all scheduled maintenance activities to be performed, and gives the operator advance notice of needed maintenance via the user screen.
The latest upgrade to the OmniLink software, a network-level program that allows centralized control over multiple Cobas b221 systems, offers users the capability for remote monitoring and virtual on-site technical support. The remote monitoring and support can simplify network troubleshooting and eliminate the need to schedule on-site calls.
Point-of-Care Devices
During the past year, point-of-care testing has seen a significantly higher level of development than in previous years. According to Gerard Conti, managing director at Enterprise Analysis Corp. (Stamford, CT), 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.
The major acquirer of point-of-care companies in 2007 was Inverness Medical Innovations. After a lengthy battle with Beckman Coulter, Inverness finally acquired Biosite for more than $1.6 billion. Biosite has been very successful in point-of-care cardiac testing with its Triage Platform.
Conti added that 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, The Netherlands) announced its intent to enter the point-of-care market with decentralized rapid diagnostic testing systems, using its proprietary magnetic biosensor technology.
In June 2007, Philips signed an agreement with Cozart (Oxford, UK), a company that specializes in drugs-of-abuse testing. Cozart and Philips will jointly work to launch a new drugs-of-abuse testing system by mid 2009. Philips has also increased its equity stake in Cozart to about 9%.
bioLytical Laboratories (Richmond, BC, Canada) received final licensing approval in Venezuela and Mexico for the Insti kit, a 60-second point-of-care HIV test. The test is a rapid, qualitative test for the detection of antibodies to HIV Type 1 in whole blood, serum, or plasma. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physician offices as a screening assay.
Inverness Medical Innovations Inc. introduced the Determine Syphilis TP, a point-of-care test for syphilis that provides results in 15 minutes. The test offers a flexible sample method as it can be used with serum/plasma or whole blood. In clinical trials, the test demonstrated excellent sensitivity using serum, and high accuracy using whole blood and paired serum and plasma. The robust format allows the test to be shipped and stored in nearly any environmental condition (2–30°C).
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The NovaMax system by Nova Biomedical (Waltham, MA).
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Quotient Diagnostics Ltd. (London) launched the Quo-Test Point-of-Care system for diabetes testing. By combining the simultaneous measurement of the test’s absorption and fluorescence quenching, this system delivers A1C results from blood in less than 3 minutes. Quo-Test is a fully automated homogeneous assay system, and it controls all the critical steps that may influence or affect the quality of the result.
Roche Diagnostics introduced the CoaguChek XS system that is used for point-of-care anticoagulation monitoring in physicians’ offices and for self-testing by patients on warfarin therapy. The system offers flexibility and control benefits that healthcare professionals can use to manage in-office prothrombin time testing more effectively. The system performs onboard quality control in the reagent chamber. It also neutralizes therapeutic levels of heparin and LMW heparin, enabling physicians to do point-of-care testing on a broad range of anticoagulated patients.
Stirling Medical Innovations (Stirling, UK) and ITI Life Sciences (Dundee, Scotland) launched SmartCheck, a handheld device that is used to determine rapidly the international normalized ratio of blood clotting for the management of long-term oral anticoagulant treatment. The device allows patients and doctors to check quickly and accurately the blood’s clotting time by placing a minute blood droplet onto a specially treated strip, which is then inserted into the meter.
Immunoassays
One 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.
“We are also seeing more im- munoassays directed to wellness or disease prevention, especially as related to diseases which are to a degree preventable, such as cardiovascular disease,” said F. Jon Geske, PhD, project director at Corgenix Medical Corp. (Broomfield, CO). “Immunoassays that are used to determine more precisely a patient’s risk of developing cardiovascular disease can now be used by physicians to change preventive treatments, including lifestyle changes, to reduce the risk. This is also further driven by the third-party payers, which in effect is forcing insured individuals to move to treatment before advanced disease sets in.”
Geske added that immunoassay technologies 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 announced that it received FDA approval to market the Abbott RealTime HIV-1 viral load test for use on the m2000 automated instrument system. The assay is designed to detect and measure level of HIV circulating in a patient’s blood, including the three major groups of HIV-1 and non-B subtypes. The test is intended for use as a marker of disease prognosis and an aid in assessing viral response to antiretroviral treatment.
Abbott Diagnostics also announced that it received approval from FDA for its Abbott Prism HCV test.
The test can be used to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV). The assay has not been validated for use with pooled specimens, and it is not intended for use on core blood specimens or for the diagnosis of HCV infection.
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The BD Directigen EZ Flu A+B test by BD Diagnostics (Franklin Lakes, NJ).
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BD Diagnostics also introduced the BD Directigen EZ Group A Strep test, a rapid chromatographic immunoassay for the qualitative detec- tion of Strep A antigen from throat swab specimens to aid in the diagnosis of group A streptococcal infection. The test offers improved ease of use with the addition of throat swabs and a test-tube holder. Test results can be read within 5 minutes, with two pink-colored bands indicating a positive result and a single pink control band indicating a negative result.
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The Access EPO assay by Beckman Coulter Inc. (Fullerton, CA).
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Beckman Coulter also introduced the Access Inhibin A, an automated assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma. The assay negates the need to split samples when processed in tandem with other reproductive assays on the Access 2 or UniCel DxI 800 Access immunoassay systems. Hospitals and laboratories use the assay to report rapid inhibin A results that aid in the diagnosis and monitoring of various reproductive hormonal disorders.
bioMérieux received 510(k) clearance for the Fluconazole Minimum Inhibitory Concentration Susceptibility test card for the Vitek 2 automated microbiology system. The tests will provide a rapid and automated method for susceptibility testing of systemic yeast infections. The test is used in conjunction with the Vitek 2 Yeast Infection card to assist clinicians in selecting optimal antifungal therapy.
Corgenix Medical Corp. received 510(k) clearance from FDA to market its AspirinWorks test kit. The test is an enzyme-linked immunoassay to determine levels of 11-dehydro thromboxane B2 in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals postingestion. The test was developed in conjunction with Creative Clinical Concepts (Denver) and Cayman Chemical Co. (Ann Arbor, MI).
Dade Behring announced the launch of the cardiac-specific CardioPhase hsCRP test for the Stratus CS Acute Care Diagnostic System. This test has been cleared by FDA for both risk assessment of future cardiovascular disease and risk stratification of recurrent events. The test may also be useful as an independent marker of prognosis of recurrent events in patients with stable coronary disease or acute coronary syndrome.
Dade Behring also announced the launch of the MicroScan Dried Gram-Negative Overnight and Synergies Plus Panels with Streamlined Extended Spectrum B-Lactamase (ESBL) tests for the confirmation of ESBLs in certain bacteria. These test panels will include confirmation of ESBL enzymes in Klebsiella pneumoniae, Klebsiella oxytoca, Escherichia coli, and Proteus mirabilits. The panels will automate the process and eliminate the need for additional tests to confirm the presence of such enzymes.
In addition, Dade Behring introduced the Innovance D-Dimer, a next-generation D-dimer coagulation test, in Europe, Canada, the Middle East, and the Asia-Pacific region. The test has a validated sensitivity for exclusion of deep vein thrombosis and pulmonary embolism. The test is a fully automated test that can be run on multiple coagulation systems offered through the company.
Inverness Medical Innovations received 510(k) clearance from FDA to market the BinaxNow malaria test in the United States. The test has been marketed outside the United States for nearly seven years, and it is the first rapid malaria test available in the United States. The company partnered with the Walter Reed Army Institute and the U.S. Army Medical Material Development Activity to conduct clinical trials to support FDA clearance.
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The BioStar OIA Shigatox assay by Inverness Medical Innovations Inc. (Waltham, MA).
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Inverness Medical Professional Diagnostics released the BioStar OIA Shigatox assay, an immunoassay for the qualitative, rapid detection of the presence of Shiga toxins in human diarrheal fecal specimens, broth culture, or colonies collected from a culture plate. The test is an aid in the diagnosis of infection by Shiga toxin–producing Escherichia coli and other Shiga toxin–producing enterhemorrhagic organisms. The assay provides a simple test methodology allowing all laboratory personnel to perform the test, with results available in 15 minutes.
Inverness Medical-Biostar Inc. (Louisville, CO) released the Clearview HIV 1/2 Stat-Pak and Clearview Complete HIV 1/2 for the professional market to provide rapid screening and detection of HIV1 and HIV2. The Clearview Stat-Pak is a cassette that can be utilized in either a waived or nonwaived laboratory. The Clearview Complete utilizes a patented barrel technology designed to maximize ease-of-use and minimize exposure to infectious agents. Both tests are FDA-approved for use with fingerstick whole blood, venous whole blood, serum, or plasma.
Nanogen Inc. (San Diego) began shipment of the StatusFirst CHF NT-proBNP rapid test, which is CE marked and has been cleared by FDA for diagnostic use with EDTA plasma samples. The test measures circulating levels of NT-proBNP and provides a quantitative assessment of the biomarker’s concentration in 15 minutes via a small reader. The test readers are designed for use in emergency rooms and hospital laboratories.
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The Vitros 5,1 FS chemistry system by Ortho-Clinical Diagnostics (Raritan, NJ).
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Ortho-Clinical Diagnostics also announced it has received 510(k) clearance from FDA for five MicroTip assays for use in the diagnosis and treatment of drug use or overdose. The five tests complete the menu of eight drugs-of-abuse assays available for use on the Vitros 5,1 FS chemistry system. The assays are used to detect the presence in urine of the following substances: barbiturates, benzodiazepines, canabinoids, methadone, and opiates.
In addition, Ortho-Clinical Diagnostics announced FDA clearance and availability of the Vitros Rubella IgG assay, which aids in the determination of immunity to rubella infection, or German measles. The assay determines if IgG antibodies to the rubella virus are in the blood. The assay is the eighth infectious disease assay available for use on the Vitros ECi/ECiQ Immunodiagnostic system in the United States.
Response Biomedical Corp. (Burnaby, BC, Canada) filed a 510(k) submission with FDA seeking clearance to market the Ramp NT-proBNP test for the diagnosis of congestive heart failure. The company also completed a European CE declaration to market the product in Europe. The regulatory submission follows positive results from the multicenter clinical trial of the test, developed under license from Roche Diagnostics.
Roche Diagnostics announced the FDA approval of the Elecsys antibody to hepatitis B surface antigen (anti-HBs) and hepatitis B surface anitgen (HBsAg) assays for use on the Elecsys 2010 and Modular Analytics analyzer platforms. The combination of analytical sensitivity and specificity of the Elecsys anti-HBs and HBsAg may be used for the laboratory diagnosis of HBV disease associated with HBV infection. Elecsys anti-HBs offers an 180-minute turnaround time and quantitative results on both analyzers.
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The D-dimer assay by Roche Diagnostics (Indianapolis).
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Roche Diagnostics also announced that it received FDA clearance for the Stat Parathyroid Hormone test on the Elecsys 1010 and 2010 systems, and the Cobas e411 analyzer. The test is an immunoassay for the quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.
In addition, Roche Diagnostics announced that it received FDA approval for the Cobas AmpliPrep/Cobas TaqMan HIV-1 test. The test is a fully automated HIV-1 diagnostic tool using real-time polymerase chain reaction (PCR) technology. The new test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level, or monitor the effects of antiretroviral therapy during the treatment course.
Siemens Medical Solutions Diagnostics announced the availability of its Enhance Liver Fibrosis (ELF) test, a standardized noninvasive blood test for assessing the status of liver fibrosis. The test combines three serum biomarkers that have been shown to correlate the level of liver fibrosis assessed by liver biopsy. The algorithm measures these biomarkers by immunoassay to create an ELF score.
Siemens Medical Solutions also introduced the Advia Centaur Cyclosporine assay, an automated test offering laboratories a highly specific immunoassay for the Cyclosporine A parent compound. The assay allows laboratories to mainstream testing into routine work flow with an extraction process and fully automated processing, yielding an 18-minute turnaround time. Laboratories can also integrate the assay onto a random access immunoassay analyzer that has the capability to perform more than 65 additional assays.
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The ß-Hydroxybutyrate assay by Stanbio Laboratory (Boerne, TX).
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Whatman plc (Florham Park, NJ) announced that the CombiChip, its multiplex protein biochip, has received CE registration for the detection of autoimmune diseases. The biochip uses an IgG concentration calibrator to quantitatively measure the presence of autoantibodies for each single patient’s sample. The chip also identifies antibodies associated with approximately 10 different collagenosis and vasculitis-related autoimmune diseases, including systemic and neonatal lupus and systemic sclerosis.
Molecular Diagnostics
Several trends emerged in molecular diagnostics during the past year. Almost all major molecular IVD manufacturers continued the drive toward greater automation in their product lines by introducing new or upgraded versions of their high-volume systems (e.g., Siemens’ Versant 440, Abbott’s m2000, BD’s Viper SP,
Gen-Probe’s Tigris DTS). While growth in IVD tests for HIV, hepatitis C virus (HCV), and hepatitis B virus continued at a moderate pace, tests for human papillomavirus (HPV) and methicillin-resistant Staphylococcus aureus (MRSA) showed impressive growth. FDA’s recent approval of updated labeling for warfarin, in which healthcare providers are given the opportunity to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients, may be a significant milestone in the emergence of genetic testing to guide drug use.
Moreover, according to David Okrongly, PhD, senior vice president, molecular diagnostics at Siemens Medical Solutions Diagnostics, there is a great deal of research interest in rapid whole genome sequencing employing nanotechnology. This trend could have significant implications for nucleic acid analysis and molecular diagnostics in the future.
“This is likely to affect the microbiology and virology fields first due to the smaller size of the genome. But migration to human genetics could come rather rapidly once robust technology is established for pathogen analysis,” said Okrongly. “Nanotechnology may also play a role in allowing for the development of ultrafast, miniaturized real-time PCR chips capable of doing thermal cycles in less than 5 seconds, thus dramatically decreasing time to result in molecular tests.”
Cepheid (Sunnyvale, CA) announced the European release of the Xpert MRSA test for clinical diagnostic use on the GeneXpert System. The test is designed to rapidly detect MRSA in patients for surveillance programs to aid in the reduction of hospital-acquired infections. The test is intended to detect MRSA directly from a nasal swab specimen and provide results in about 75 minutes. The test later received marketing clearance from FDA and moderate complexity categorization under the Clinical Laboratory Improvement Amendments (CLIA).
DxS Ltd. (Manchester, UK) launched the TheraScreen EGFR29 kit, which is used as an aid to doctors in selecting lung cancer patients suitable for treatment with tyrosine kinase inhibitor therapies. The kit detects 29 of the most common somatic mutations in the epidermal growth factor receptor (EGFR) gene. The test optimizes the selection of those patients who are likely to respond to therapy by identifying the mutation status of patients.
Ikonisys Inc. (New Haven, CT) announced that FDA cleared the fastFish autoamniocyte application for marketing in the United States. This testing application allows for automated identification and enumeration of chromosomes 13, 18, 21, X, and Y in amniotic fluid cells via fluorescence in situ hybridization. The product is designed to run on the Ikoniscope robotic digital microscopy platform.
Invitrogen Corp. (Carlsbad, CA) announced the availability of the E-Gel CloneWell Sybr Safe gels and E-Gel iBase Power System. The E-Gel CloneWell gels feature two rows of wells; samples are loaded into the top row and electrophoresis is carried out until the band of interest moves into the bottom row of wells from which it can be retrieved with a pipette. The E-Gel iBase Power System has a built-in power supply and fits on the Safe Imager Blue-Light Transilluminator so the user can safely watch the DNA bands migrate in the gel.
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The MultiGene Gradient Thermal Cycler by Labnet International Inc. (Edison, NJ).
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Nanogen Inc. submitted a 510(k) to FDA for its Cystic Fibrosis Kit and NanoChip 400 microarray system. The kit is intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The NanoChip instrument is an automated multiplexing platform that laboratories use to detect genetic sequences.
Roche Diagnostics announced that FDA accepted for review its applications for two HPV tests. One of those tests, the Amplicor HPV test, is designed to enable accurate detection of 13 of the more common high-risk HPV genotypes in standard clinical samples. The other test, the Linear Array HPV Genotyping test, is designed to identify which of the 13 high-risk HPV genotypes are present in a sample.
Siemens Medical Solutions Diagnostics announced that the Versant 440 Molecular System was approved for marketing by Health Canada for viral load testing of HIV and HCV. The system uses branched DNA technology that simplifies testing by eliminating nucleic acid extraction and the risk of cross-contamination. In addition, the system is a viral load platform designed for flexible walkaway automation.
Tm Bioscience Corp. (Toronto) announced that it received CE mark status for the ID-Tag Respiratory Viral Panel. The test simultaneously detects up to 20 distinct viral sequences and subtypes that represent more than 95% of all circulating respiratory viruses. Such viruses targeted by the test are important for patient management and include respiratory syncytial virus A and B, influenza A and B, and viruses important for public health and pandemic surveillance (e.g., SARS and influenza A H5).
Veridex LLC (Warren, NJ) announced that it received FDA approval for the GeneSearch Breast Lymph Node Assay. The assay detects metastases greater than 0.2 mm in sentinel lymph node tissue removed from breast cancer patients. In clinical trials, the test correctly identified 95.6% of patients who had metastases in their lymph nodes. The gene-based technology of the test allows for the analysis of 50% of the sentinel node, versus 5% of tissue typically examined under a microscope for evidence of cancer cells.
XDx (South San Francisco, CA) announced expanded use for the AlloMap molecular expression test. AlloMap testing, a noninvasive method to detect the absence of acute cellular rejection in heart transplant recipients, can now be used as early as two months posttransplant to rule out rejection. In addition, patients who are greater than two months but less than six months posttransplant and who have an AlloMap test score below 20 are predicted by the test to be free from acute cellular rejection for 80 days or 12 weeks.
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 prosperous year for IVD manufacturers. However, various mergers and acquisitions in the IVD industry could significantly shape 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 moreaccurate 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.
