By: Richard Park

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 $56 billion industry by 2012.

“The economic conditions have not changed our forecasts for the routine IVD market,” says Shara Rosen, lead 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 continues 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 planned federal healthcare initiatives still bode well for testing. But the simplest explanation about 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 with 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.

Instrumentation and Automation

One emerging trend in laboratory instrumentation and automation is the automatic management of reagents and consumables inventory in the labs. This concept encompasses real-time management of reagents and consumables both on the instrument in the lab and off the instrument in a separate inventory location.

“Currently, labs spend a significant amount of time managing their inventory of reagents across a broad range of assays, lot expiration dates, and instrument platforms,” says Gerrit C. Smith, manager, instrument manufacturing at Abbott Diagnostics (Abbott Park, IL). “Labs that are part of a larger hospital network may also need to coordinate the purchase of new reagents with a consolidated purchasing group, adding additional complexity and time to the process. Another factor includes the occasional changes in assays that require unplanned testing (e.g., precision and accuracy, patient correlation studies). All of these factors make managing the inventory of reagents and consumables a difficult task.”

A possible solution includes instrument software that provides real-time monitoring of instrument-specific reagents and consumables. Such materials would be monitored both on the instrument when consumed and off the instrument in a separate inventory location. RFID tags could provide such real-time monitoring capability. The system would send an alert notice to lab management when inventory levels reach a predefined level. Such a notice in turn could automatically trigger a purchase order to a supplier, which is customized to the predefined inventory level. In another scenario, a supplier could monitor the labs' materials and automatically ship at predefined inventory levels.

“As labs continue to be challenged to reduce costs, there will be an increasing need to look outside of the traditional lab workflow to improve efficiencies,” says Smith. “The focus will start to shift from improving productivity in the lab to improving productivity in planning and purchasing of lab materials. Real-time materials management offers one significant area of opportunity to improve efficiency by reducing inventory levels and costs associated with managing materials.”

Abbott Diagnostics (Abbott Park, IL) received 510(k) clearance from FDA for its compact hematology instrument, Cell-Dyn Emerald. The Cell-Dyn Emerald will expand the company's hematology platform by offering a solution for small to mid-sized clinical laboratories. As small to mid-sized hospital laboratories and clinics continue to seek greater efficiency and productivity under tighter space limitations, Emerald's small size, touch screen software, and reliability offer an easy-to-use, compact table/benchtop instrument for performing complete blood counts.

Abbott also launched the Architect c4000 clinical chemistry analyzer, which performs diagnostic tests that monitor general health including a patient's levels of sodium, potassium, chloride, and organ function. The Architect c4000 seamlessly integrates with Abbott's i1000SR immunoassay analyzer to form the Architect ci4100, an automated analyzer that completes both immunoassay and chemistry tests on one platform. With these two products, Abbott now offers chemistry, immunoassay, and integrated diagnostic testing solutions to improve the performance and efficiency of laboratories of all sizes.

Beckman Coulter Inc. (Fullerton, CA) released the UniCel DxH 800 Coulter Cellular Analysis System for mid-to-high volume laboratories. The new instrument features advanced technologies, including high-definition signal processing and multi-angle light scatter, which produce ten times more data than traditional hematology analyzers. Moving parts are minimized to increase instrument reliability and technologist safety. The DxH 800's modular design and small footprint make it a scalable solution for a lab.

Building on the UniCel DxC 880i and the UniCel DxC 600i, Beckman Coulter also introduced three new chemistry/immunoassay integrated workcells: the UniCel DxC 660i, the UniCel DxC 680i, and the UniCel 860i Synchron Access Clinical Systems. The company has dubbed the series of five work cells UniCel i class. Each of the integrated systems is configured to meet a different level of throughput and features Beckman Coulter's ClozCap technology (automated closed-tube aliquotting and sampling), which frees technologists from the labor-intensive task of decapping, recapping, and sorting samples manually.

Ortho Clinical Diagnostics Inc. (Raritan, NJ) received 510(k) clearance from FDA for its Vitros 5600 Integrated System. This next-generation system is designed to integrate clinical chemistry and immunoassay testing to increase laboratory productivity, and will be able to perform more than 100 different chemistry, immunoassay, and infectious disease assays on a single system. In addition to its current broad menu including user-defined applications, the Vitros 5600 Integrated System will have the capability to run future tests for earlier detection of diseases. Commercial availability is expected in the fourth quarter of this year.

Ortho Clinical Diagnostics also obtained 510(k) clearance from FDA for its Vitros 3600 Immunodiagnostic System. This high-capacity immunoassay system provides laboratories with a solution to address their quality, labor, and cost challenges. The Vitros 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on Vitros technologies. Designed with the input and feedback from a diverse group of laboratories around the world, the Vitros 3600 Immunodiagnostic System complements and extends the capabilities of the Vitros family of instruments.

PerkinElmer Inc. (Waltham, MA) introduced the Flexar liquid chromatography (LC) platform, which will be controlled by the Chromera Chromatography Data System. Flexar incorporates a new ergonomic industrial design and delivers a wide range of pressure options intended to address the increasingly demanding application needs of high-pressure liquid chromatography (HPLC) laboratories. The company's new multitiered platform offers solutions from semiprep to ultrahigh-pressure liquid chromatography (UHPLC).

Roche Innovatis (Penzberg, Germany) launched Cedex HiRes, the newest generation of image-based Cedex Cell Counter and Analyzer systems for automated cell culture analysis. Cedex HiRes measures cell density, viability, aggregation rate, cell morphology, and cell debris using the Trypan Blue exclusion method, with high-resolution digital image recognition. The image quality allows deeper insights into even the subtlest changes in a cell culture, such as monitoring baculovirus transfections for protein production via measurement of cell diameter changes.

Siemens Healthcare Diagnostics (Deerfield, IL) introduced the RapidPoint 340 and 350 Blood Gas Analyzers for low- to mid-volume critical care patient testing sites. These two models are small, easy-to-use cartridge-based systems. The simplicity of these systems is ideal for operators in a variety of critical care testing sites, including intensive care units, operating or emergency rooms, and clinical laboratories. The RapidPoint 340 analyzer measures pH and blood gas (oxygen and carbon dioxide). The RapidPoint 350 analyzer also measures the electrolytes sodium, potassium, calcium or chloride, and hematocrit.

Siemens also launched a next-generation integrated chemistry and immunochemistry system for use in mid-volume clinical laboratories. The Dimension EXL system with LM (Loci Module) uses Loci advanced chemiluminescence technology, allowing labs access to fast, sensitive immunoassay testing on an integrated platform. Loci technology allows for fast analytical turnaround time of ten minutes for critical cardiac tests such as high-sensitivity Troponin I.

In addition, Siemens launched the Dimension Vista 500 Intelligent Lab System, the latest addition to the company's family of ultra-integrated chemistry and immunochemistry systems. The new system has a test menu of more than 115 assays and offers test panels for anemia, cardiac disease, thyroid disorders, therapeutic drug monitoring, protein testing, drugs-of-abuse testing, routine and specialty chemistry testing, all on one system and from a single patient sample. With the option of two configurations, the system meets the varying needs of mid-volume laboratories.

Thermo Fisher Scientific Inc. (Waltham, MA) introduced a drug screening and confirmation solution for forensic toxicology based on its Exactive benchtop LC/MS (liquid chromatography-mass spectrometry) platform. The solution incorporates the ultrahigh resolution LC/MS capabilities of the company's proprietary Orbitrap technology. The new system expands the current clinical research portfolio of Thermo Fisher's triple-stage quadrupole and ion trap LC/MS solutions.

Data and Information Management

Laboratories are facing increasing demands for the collection and transfer of data. Pathologists and doctors can make better medical decisions if data is collected and analyzed from multiple diagnostic sources (e.g., clinical, radiology, molecular). Laboratory operations can be streamlined by capturing the statics related to the laboratory workflow and making improvements based on the test results. Upstream IT systems that provide electronic health records, personal health records, and operational status such as inventory levels must be developed, which in the past were inaccessible. The ever increasing demands for data and the integration of that data into meaningful information will shape the future of laboratory healthcare information systems and IVD instrumentation:

• IT infrastructures that allow the capture and integration of data.

• IVD instruments that provide more than just test results to laboratory information systems (LIS).

• Applications that multiplex data from multiple destinations and sources to ensure the right data gets to the right locations.

• Applications that collect and concentrate data from multiple sources.

• Applications that efficiently analyze data and disseminate it as useful information.

“IVD instruments, middleware software applications, and laboratory information systems must evolve in a manner that supports these data needs, while at the same time providing efficiency improvements that streamline the operation of the laboratory,” says Ed Heierman, PhD, informatics and software systems architect, systems development and core R&D at Abbott Diagnostics. “Critical to this evolution will be the proper allocation of capabilities (e.g., data collection, analysis, and transfer) across these products in order to minimize duplication and complexity. Currently, the overlap in features such as decision support and quality control (QC) across these products causes confusion, possibly inconsistent outputs, and workflow inefficiencies. What will be needed are laboratory information management applications and IVD instruments that are optimally integrated to meet the information demands of the laboratory.”

Abbott Diagnostics introduced the Abbott Prism Director, a computer system that enhances laboratory efficiency by managing test data for multiple Abbott Prism systems. In addition to managing data, Abbott Prism Director offers laboratories the ability to track and trend QC and performance of blood-screening assays, and will provide laboratories with more robust data back-up capabilities through expanded archival features. The system also will help blood-screening laboratories better manage retesting of samples, produce custom reports, and generate statistical charts to improve workflow.

Hamilton Robotics (Reno, NV) introduced the Total Aspiration and Dispense Monitoring (TADM) Lab Analyzer for Microlab Star and Starlet liquid handling workstations. Made possible through a collaboration with Apartis Information Management, this new software solution enhances the usability of TADM data from Hamilton STAR workstations by displaying it in graphical, easy-to-interpret formats. TADM Lab Analyzer retrieves and visualizes precise, real-time pressure monitoring data, enabling the user to confirm accurate aspiration and dispense for each sample plate well.

Siemens Healthcare Diagnostics launched a new version (5.0) of the EasyLink Informatics product, providing more workflow enhancement opportunities, connectivity to new instruments, and a fully integrated Web-based QC package. EasyLink connects multiple instruments to an LIS to consolidate patient data management. With this addition, Siemens continues to offer a scalable informatics option for all sizes and types of clinical laboratories, and extends connectivity options to more instruments across the clinical laboratory for improved patient and QC data management.

Thermo Fisher Scientific launched Lab Forms 2.5, a suite of new GC/MS software aimed at specific laboratory applications. Providing optimal productivity, the Lab Forms 2.5 packages fit into laboratory workflows for routine GC/MS analysis. Designed for users in environmental, clinical research, forensic toxicology, food safety, and general QA/QC laboratories, these new software packages incorporate Method Forge, which provides an automated pathway to generating full scan methods. Wizards and templates ensure the programming of daily batches is straightforward, reducing the time required to queue samples and begin data acquisition.

Point-of-Care Devices

While the point-of-care (POC) testing market has been driven lately by new company activity and landmark mergers and acquisitions, the past year has seen the POC market returning to business as usual. For example, in the cardiac marker realm, Troponin I and BNP testing still rein supreme, although promises of new high-performance markers are still being discussed at industry meetings. And even though Roche Diagnostics (Indianapolis) took an interesting step by partnering with Response Biomedical Corp. (Vancouver), Biosite still commands a powerful presence in cardiac markers and drugs-of-abuse testing, due in part to assistance from its parent company, Inverness Medical Innovations Inc. (Waltham, MA). As for Inverness, its interest in bringing tests to the home market, including BNP, has been an interesting development. Industry analysts are cautioning skeptics to hold their breath, especially since laboratorians once boasted that POC cardiac tests would never work.

“In fact, with regard to Inverness, I can't help but think about how the supply chain in the POC world is evolving,” says David Pearman, marketing manager, hemostatis/POC divisions at Helena Laboratories Corp. (Beaumont, TX). “IVD companies have had their challenges penetrating the evolving and growing integrated delivery networks and group purchasing organizations. But dedicated distribution networks such as Quality Assured Services Inc. (QAS), which was recently purchased by Inverness, seem to be working hard at not only taking business but also discovering how to retain business. Certainly, the QAS model will lay the groundwork for infiltrating the at-home/patient self-testing market.”

In the broad POC testing menu area, the i-Stat system by Abbott Diagnostics continues to hold its place, and Epocal Inc. (Ottawa) still talks about its smart card technology. However, the stifling economy this year has squelched even the best POC innovations. The lack of venture capital and other investment funding has slowed down the development of emerging POC technologies. Nonetheless, some IVD companies continue to earn respect in the coagulation area—such as Helena Laboratories by launching the Cascade POC—and provide support by developing additional steps.

Abbott Diagnostics announced that FDA granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-Stat handheld blood analyzer. The five are components of the Chem8+ cartridge, which FDA waived in 2007. The Chem8+ cartridge allows a clinician to run a basic chemistry panel on a patient together with hemoglobin and hematocrit tests.

Inverness Medical released a fourth-generation rapid HIV diagnostic test, Determine HIV 1/2 Ag/Ab Combo. The test is capable of detecting HIV infection several days earlier than HIV antibody-only tests, and is ideal to help diagnose and screen for early HIV infection. Determine HIV-1/2 Ag/Ab Combo enables simultaneous separate detection of HIV p24 antigen and antibodies for HIV-1 and HIV-2 in human serum, plasma, or whole blood.

MEC Dynamics Corp. (Santa Clara, CA) received 510(k) clearance from FDA for its new POC test, the Avie A1c, for the quantitative measurement of HbA1c in diabetic patients. Avie A1c has many features designed to deliver quick and accurate results for HbA1c. Using blood from a fingerprick and a single-use disposable cartridge, HbA1c results are displayed on the screen of the handheld reader within 3 minutes. The Avie A1c is NGSP-certified for accuracy.

Roche Diagnostics introduced the Roche Cardiac 200, a comprehensive testing solution for rapid cardiac diagnostic needs in point-of-care testing environments. The latest addition to Roche's portfolio of cardiac solutions, the Roche Cardiac 200 is a lateral-flow immunoassay testing system designed to provide quantitative cardiac marker test results on whole blood samples with a turnaround time of only 10-19 minutes, to help meet best-practice guidelines for emergency department settings.

Stanbio Laboratory LP (Boerne, TX) announced the availability of its improved hemoglobin system. The upgraded, CLIA-waived HemoPoint H2 Test System offers a 4,000-test-result memory, faster time-to-result, and a battery backlighting feature. The new HemoPoint H2 recalls 4,000 patient results, an improvement from the previous 100-test-result memory, ensuring accurate patient data tracking. A hemoglobin and calculated hematocrit result can now be read in as little as 10 seconds, a time-to-result that is approximately 65% faster, allowing for accurate testing in a time-critical setting.

Immunoassays

In the area of immunoassays, IVD manufacturers continue to see the development of increasingly sensitive detection methods that surpass the limits of detection that can be achieved with traditional immunoassay formats. Unfortunately, many of these new methods require specialized instrumentation that is either not available or not affordable for smaller clinical laboratories.

Another emerging trend in immunoassays is the move toward more personalized testing and screening of individual therapies. Some new assays are beginning to answer the question of whether specific drugs are doing what they are supposed to do in individual patients. As molecular techniques identify increasingly specific genetic variabilities, more specific targets for developing antibodies have allowed immunoassays to answer not only quantitative but also functionality questions. This trend should continue into the foreseeable future.

Immunoassay technologies themselves are also evolving. The use of enzymes continues to be replaced by more sensitive fluorescent and chemiluminescent technologies. In addition, immunoassays are continuously moving toward offering multiple analyte measurements in single kits. This trend is again in line with offering more personalized testing for individuals.

Abbott Diagnostics received premarket approval (PMA) from FDA for Architect Core, an automated hepatitis B test for use on its Architect i 2000 and i 2000SR immunoassay testing instruments. Architect Core is a chemiluminescent microparticle immunoassay for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen in adult and pediatric serum and plasma, and neonatal serum. It is intended as an aid in diagnosing acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.

Abbott also announced the availability of an improved, fully automated assay for the qualitative determination of hepatitis B surface antigen in human serum or plasma on its Architect immunoassay system. According to clinical trial data, the Architect HBsAg Qualitative assay features improved specificity of 99.97% in blood donor populations and 100% in hospital patients. The new assay can run up to 200 tests per hour, accepts a wide range of different blood samples, and allows refrigerated sample storage for up to 14 days, making it easier to transport samples between testing laboratories.

ADMEcell Inc. (Emeryville, CA) introduced a ready-to-use Caco-2 cell assay shipped at room temperature. The CacoReady System is a ready-to-use concept for in vitro intestinal absorption evaluation. This system is an integrated tool designed to minimize time and costs for preclinical screening of oral compounds. CacoReady is suited for assessing permeability and can be adopted for high-throughput screening of compounds. It is shipped at room temperature in a proprietary shipping medium on day 15 of differentiation.

Beckman Coulter received FDA approval for the Access Soluble Transferrin Receptor (sTfR) Assay and the sTfR/log ferritin index as an aid in the diagnosis of iron deficiency anemia (IDA) and the differential diagnosis of IDA and anemia of chronic disease. The automated sTfR assay used in combination with the sTfR Index, which is calculated on Beckman Coulter's Access and UniCel DxI instruments, produces a recommended cutoff that can indicate the nature of a patient's anemia.

Beckman Coulter also expanded its renal menu with the addition of Gentian Cystatin C Immunoassay, an assay for the quantitative determination of cystatin C in human serum and plasma. When used on the Beckman Coulter Synchron and UniCel Clinical Systems, the Gentian Cystatin C Immunoassay is used in the diagnosis and treatment of renal disease. Reagents and calibrators for the Gentian Cystatin C assay are liquid and ready to use, eliminating the need for mixing, hydrating, or prediluting reagents before testing.

Bio-Rad Laboratories Inc. (Hercules, CA) announced the FDA clearance of two multiplex infectious disease serology panels for use on the BioPlex 2200 system: the BioPlex ToRC IgG panel and the BioPlex HSV-1 & HSV-2 IgG panel. The ToRC IgG kit simultaneously detects IgG class antibodies to Toxoplasma gondii, Rubella, and Cytomegalovirus. The HSV-1 & HSV-2 IgG kit utilizes type-specific proteins to simultaneously detect and differentiate IgG class antibodies to the two most common herpes subtypes, HSV-1 and HSV-2.

Cisbio Bioassays (Bagnols-sur-ceze, France) launched its chromogranin A ELISA diagnostic tool, Chromoa. This ELISA kit complements Cisbio's existing chromogranin A RIACT kit and can be used by all laboratories for detecting and monitoring neuroendocrine tumors. Chromoa is a highly sensitive, monoclonal antibody-based assay used to identify increased protein levels in serum when a neuroendocrine tumor is present in the human body.

Inverness Medical Innovations launched the Clearview Malaria rapid test range, which provides a complete, rapid diagnostic solution for in vitro detection of malarial antigens in whole blood. This test is available in two different formats. Clearview Malaria P.f. is a qualitative test for detecting the most common, virulent, and deadly malaria-causing parasite, Plasmodium falciparum. Clearview Malaria Combo detects and differentiates between the Plasmodium falciparum, P. vivax, P. malariae, and P. ovale antigens.

Luminex Corp. (Austin, TX) received clearance from Health Canada for its xTAG Respiratory Viral Panel (RVP). From one patient sample, xTAG RVP simultaneously detects the 18 respiratory viruses and subtypes that are responsible for the majority of respiratory viral infections. These viruses include influenza, rhinovirus, and metapneumovirus. The test has the potential to improve patient care, reduce healthcare costs, and prevent inappropriate antibiotic use that has contributed to the creation of superbugs.

MP Biomedicals LLC (Singapore) announced the availability of Assure Dengue IgA Rapid Test. This assay is a reverse flow immunochromatographic rapid test for qualitative detection of anti-dengue IgA antibody in human samples, which not only increases the sensitivity of the technique but also makes the test useful at the acute phase of infection at any level of the healthcare system. The test was found to detect more dengue-positive cases during the acute stage of infection than other dengue diagnostic tools.

Ortho Clinical Diagnostics announced FDA approval of the Vitros Anti-HCV assay for use on the Vitros 5600 Integrated and 3600 Immunodiagnostic Systems. This approval enables the consolidation of hepatitis C testing with routine assays on the Vitros 5600 Integrated System. The Vitros Anti-HCV assay is an IVD immunoassay for the qualitative detection of immunoglobulin G antibody to hepatitis C virus in human serum and plasma. It can be run with precision, sensitivity, low sample volume requirements, and quick, random access results on the Vitros Systems, with results available in 55 minutes.

PBL InterferonSource (Piscataway, NJ) introduced the new high-sensitivity VeriKine Cynomolgus/Rhesus Interferon-Alpha Serum ELISA kit for determining macaque IFN-Alpha levels. This assay enables interferon quantification in Cynomolgus and Rhesus Macaque model systems for viral disease, autoimmune disorders, and immunotoxicology. VeriKine Cynomolgus/Rhesus IFN-Alpha Serum ELISA kit has superb matrix compatibility. It is sensitive to 25 pg/mL and can detect the protein in a wide variety of sample matrices and test concentrations with an accuracy of ±20%.

ReaMetrix India Pvt Ltd. (Bangalore, India) launched the Dry Tri-T Stat product used in HIV management. This test is the only FDA-cleared dried-down CD4 enumeration product available in the world today for the flow cytometry instrumentation market. This unitized, dried-down delivery format eliminates the need for refrigeration, exhibits nearly 99% correlation with conventional liquid formats, and is at least three times more affordable than other products on the market today.

Roche Diagnostics introduced the Anti-TSHR assay, the only fully automated TSH receptor antibody test available for use on the Roche cobas e 601 and cobas e 411 analyzers, Modular Analytics E 170 module, and Elecsys 2010 system. With a turnaround time of only 27 minutes, the Anti-TSHR assay delivers patient results more than two hours faster than other tests. The Anti-TSHR assay can be run with other thyroid tests, and by utilizing one sample tube, it can provide greater efficiency in processing both traditional and novel thyroid markers.

Roche also added the Elecsys total PSA and Elecsys free PSA assays to its immunoassay tumor marker menu for the cobas 6000 analyzer series. The Roche Elecsys total and free PSA assays bring added benefits and improved efficiencies to the lab, including Roche ECL technology for better precision, an 18-minute turnaround time, and a 20-µL sample size for both assays. With the addition of the Roche Elecsys total and free PSA assays, Roche enhanced its comprehensive tumor-marker portfolio.

In addition, Roche announced FDA approval for the HBsAg and Anti-HBs assays for use on the cobas 6000 analyzer series and the cobas e 411 analyzer. With the addition of the HBsAg and Anti-HBs assays, Roche enhanced its comprehensive immunoassay and clinical chemistry reagent menu. The addition of these assays also completes the availability of Roche's hepatitis assays across the entire range of analyzers for low-, mid-, and high-volume testing. Both the HBsAg and Anti-HBs assays provide fast, predictable 18-minute turnaround times and deliver high-performance results with Roche ECL technology.

Stanbio Laboratory announced the availability of a user defined application on the Dade Dimension for their beta-Hydroxybutyrate assay. The assay is used for the determination of beta-hydroxybutyrate (blood ketone) in serum and plasma specimens. The Stanbio test is specific for beta-hydroxybutyrate, the predominant ketone body. It is not affected by interfering substances and shows a high linearity of up to 4.5 mmol/L. The reagent set requires no reagent preparation and is designed to be used in Reagent-Start (R1/R2) systems.

Molecular Diagnostics

Molecular diagnostics is one of the fastest growing segments of the IVD market. Although it still accounts for only a small percentage of the total market, the molecular diagnostics segment is expected to grow rapidly during the next five years. During this past year, infectious diseases and women's heath remained the largest segments of the molecular diagnostics market. These segments are dominated by a limited number of FDA-cleared tests for HIV, hepatitis C virus (HCV), hepatitis B virus (HBV), chlamydia, and gonorrhea. Human papillomavirus (HPV) is another rapidly growing area.

“Molecular diagnostics have great clinical and business potential as they can identify viruses and infectious diseases more accurately at earlier stages than traditional IVD methods,” says Sha-Sha Wang, PhD, senior project scientist, research and development at BD Diagnostics (Sparks, MD). “In order to support the healthcare experts' decision-making process, molecular diagnostics has made a major impact on the early diagnosis of infectious diseases and early detection of life-threatening diseases, such as HIV and cervical cancer. In recent years, scientists have also gained a better understanding of the human genome and have made significant strides in pharmacogenomics and biomarker discovery. Consequently, an increasing number of IVD companies are sharpening their business focus on molecular diagnostics. Many biotech and pharmaceutical companies are also shifting their focus to join the molecular diagnostics business, with some forming their own independent molecular diagnostics business units.”

The major factors fueling the growth of molecular diagnostics in the IVD market include the increasing incidences of various chronic diseases and innovations in molecular diagnostics delivering new technologies for fully automated testing platforms. New molecular assays and platforms offer healthcare experts simple, fast, and more precise screening and test tools, which significantly improve the diagnostics decision-making process.

“New technologies and assay additions for infectious diseases, molecular oncology, and women's health add even more promise to this growing field,” says Wang. “Other evolving areas include genetic testing, pharmacogenomics, and personalized medicine, which will transform disease risk assessments and drug selection, thereby improving the cost effectiveness and clinical aspects of patient care. With so much growth and potential, the molecular diagnostics market has a long way to go before it reaches maturity.”

AdvanDx received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH to identify E. coli and/or Pseudomonas aeruginosa directly from positive blood cultures. E. coli/P. aeruginosa PNA FISH is the first test for identifying E. coli and P. aeruginosa directly from positive blood cultures and the latest addition to AdvanDx's molecular-based PNA FISH diagnostics platform. PNA FISH tests provide rapid species identification for the majority of Gram-stain results in hours instead of days.

BD Diagnostics received 510(k) clearance from FDA for the BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the next-generation BD Viper System with XTR Technology. This improvement in process efficiency may lead to a higher number of accurate diagnoses and more appropriate patient care for the two most common sexually transmitted infections, chlamydia and gonorrhea.

Beckman Coulter introduced the SPRI-TE Nucleic Acid Extractor for the automated purification of DNA and RNA. This system prepares between one and ten samples in about 30 minutes and requires minimal user training. Prepackaged, ready-to-use extraction kits are available for preparing genomic-DNA, viral or formalin-fixed, paraffin-embedded nucleic acid samples. SPRI-TE incorporates the company's proprietary solid-phase reversible immobilization technology, which extracts the nucleic acids without centrifugation or vacuum manifold.

Cepheid (Sunnyvale, CA) received FDA clearance to market its Xpert MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) in skin and soft tissue infections. In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with MRSA or SA.

CombiMatrix Corp. (Mukilteo, WA) introduced the first prostate cancer array-based test. Known as the ProScan test, it complements the company's growing portfolio of array-based diagnostic tests. The ProScan test comprises probes for specific genomic loci of which copy number gains and losses have been shown to correlate with risk of recurrence and metastasis in patients post-prostatectomy. These additional probes are a further enhancement of the CMDX solid-tumor-array platform design, which enables whole-genome tumor profiling while also providing information about the copy-number status of specific disease-associated loci.

Hologic Inc. (Bedford, MA) announced that FDA approved the company's PMA applications for both the Cervista HPV HR and the Cervista HPV 16/18 tests. Cervista HPV HR is designed to detect the 14 high-risk types of HPV known to cause cervical cancer and is the first HPV DNA test approved by FDA in more than 10 years. Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.

Integrated DNA Technologies (Coralville, IA) launched the PrimeTime qPCR assays, which contain dual-labeled probes and primers mixed for use in the 5' nuclease process. The PrimeTime qPCR assays are custom-designed with a validated real-time PCR design algorithm. This real-time PCR design tool allows the researcher to customize the thermodynamic parameters to match their specific assay requirements, and incorporates genome and transcript information in the primer and probe design.

Luminex Corp. launched two cystic fibrosis (CF) tests in Europe: the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2. The xTAG tests will provide assistance in cystic fibrosis screening for newborns and confirmatory diagnostic testing in newborns and children. The xTAG Cystic Fibrosis 39 Kit v2 can detect up to 39 of the most common CFTR gene mutations from a child's or parent's blood sample or bloodspot. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are found in specific ethnic populations.

The xTAG tests also are uniquely designed to be fast and easy to use, requiring only about one hour of hands-on time to process 48 purified samples. They offer physicians the ability to select the CFTR gene mutations for which they want to test. Additionally, reflex tests are incorporated in these kits. All results are revealed and available for analysis at each run. With validated performance criteria, the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2 are highly accurate and reproducible.

Prodesse Inc. (Milwaukee) received 510(k) clearance from FDA to market its Pro hMPV+ Assay. Pro hMPV+ is a molecular diagnostic assay that detects human metapneumovirus (hMPV). It is the first real-time molecular diagnostic test for hMPV to receive FDA clearance, and is the second member of Prodesse's Plus family of respiratory virus assays to be cleared. The Pro hMPV+ Assay uses real-time polymerase chain reaction (PCR) technology. It is simple to use and easily integrates into existing lab workflow.

Prodesse also received 510(k) clearance from FDA to market its ProGastro Cd Assay as an IVD product in the United States. ProGastro Cd uses real-time PCR technology and has been optimized for the use of automated extraction technology so that its inhibition rate is low. Clinical trials were conducted at three clinical laboratories in the United States. They reported that ProGastro Cd was easy-to-use and that it rapidly and accurately detected toxigenic strains of Clostridium difficile.

Roche Molecular Diagnostics (Pleasanton, CA) received CE Mark certification for its Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0. This highly sensitive test offers Roche's fully automated real-time PCR technology to achieve a broad dynamic range for the quantitative detection of HBV DNA in patient plasma and serum. The test can detect genotypes A-H and precore mutants. It offers a broader dynamic range than previous-generation tests, from as low as 20 IU/mL and as high as 1.7E+08 IU/mL.

Roche also announced that its new LightCycler test for the detection of MRSA is available with the CE Mark. The LightCycler MRSA Advanced Test is a qualitative IVD test for the direct detection of nasal colonization with MRSA. The test is performed on Roche's LightCycler 2.0 instrument with nasal swab specimens from patients suspected of colonization, using Roche's patented real-time PCR technology. Provided in a convenient, ready-to-use format, and designed for flexible batch sizes, the LightCycler MRSA Advanced Test ensures safety and productivity of laboratory staff, flexible throughput, and accurate and reliable results.

Seegene Inc. (Rockville, MD) introduced the Seeplex MTB ACE detection test. The test provides simple and fast detection in a single multiplex PCR that uses multiple genetic targets, IS6110 and MPB64. The Seeplex MTB ACE detection test uses a single multitarget amplification for specific detection of M. tuberculosis, and is based on the company's Dual Priming Oligonucleotides PCR technology. By simultaneously amplifying IS6110 and MPB64, Seeplex MTB ACE can identify infections that would otherwise go undiagnosed. The Seeplex MTB ACE Detection detects both extra-pulmonary and pulmonary TB from various specimens.

Conclusion

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 of ever-better diagnostics, IVD Technology will be here to take note of their progress.