AUTOMATION
Automated Workflow Series
Increases efficiency, maximizes safety
Roche Diagnostics, Indianapolis, introduced its cobas 8100 automated workflow series to the US market 
at the 2013 AACC Clinical Lab Expo. Using intelligent robotics, the cobas 8100 series automatically prepares blood samples for immediate testing and postanalytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and efficient sample transport options and great flexibility, allowing labs to automate both routine and STAT tests. Availability in the United States is expected in 2015.
Roche Diagnostics
(317) 521-2000; www.roche-diagnostics.us
COMPUTERS/IT
New Decision Support Software
Extended delta
A new version of the WAM Decision Support Software for the Clinical Lab from Sysmex America Inc, Lincolnshire, Ill, includes an extended delta and previous checking module that goes beyond the 
traditional delta checking by adding the ability to “look back” and determine the absence or presence of flags, comments, and operator alerts over a range of results. The ultimate goal is to reduce the number of unnecessary smear reviews or manual differentials, and the system truly elevates the multivariable checking for both Delta and Previous data checks. The company is also previewing expanded support services that will provide automated rule and workflow testing services for Sysmex WAM customers during implementation.
Sysmex America Inc
(847) 996-4500; www.sysmex.com
EQUIPMENT
Undercounter Refrigerators and Freezers
Chamber temperature
uniformity with quick recovery
The i.Series and Horizon Series Undercounter Refrigerators and Freezers from Helmer Scientific, 
Noblesville, Ind, are available in ADA-compatible models. The units fit beneath 34-inch, ADA-compliant counters. They offer excellent chamber temperature uniformity with quick recovery, bacteria-resistant powder coating, and a self-closing door with magnetic latch. These models can be placed under the counter, used freestanding, and stacked. i.Series models include a door-mounted i.C³ user interface with full-color touchscreen. Horizon Series models include a door-mounted alarm/monitoring system. Custom storage options are available and include shelves, rollout baskets, and drawers. LED lighting, swivel casters, and glass doors are also available.
Helmer Scientific
(800) 743-5637; www.helmerinc.com
Benchtop Centrifuge
Small size offers flexibility
The Sorvall ST 8 from Thermo Fisher Scientific, Waltham, Mass, is a versatile, small benchtop centrifuge featuring a compact design. The 
centrifuge offers application flexibility, cleaning convenience, and ease-of-use with Thermo ScientificAuto-Lock rotor exchange. It has the capacity to spin blood tubes, conical tubes, and microtubes, and offers microplate compatibility with sealing options. Other features include a glove- and detergent-friendly interface with a bright backlit display, one-touch operation with preset protocol options, and optional password protection.
Thermo Fisher Scientific Inc
(800) 766-7000; www.thermofisher.com
Blood Glucose and ß-Ketone Monitoring System
Wireless access to results
Abbott, Abbott Park, Ill, has received FDA clearance for its FreeStyle Precision Pro Blood Glucose and 
ß-Ketone Monitoring System. It uses individually foil-wrapped test strips, helping to reduce the risk of test strip cross-contamination of blood and bacteria. The system allows for real-time, dual-band wireless communication between the handheld meter at the patient bedside and the hospital information system, giving clinical staff immediate access to patient test results throughout the facility. The system features a new algorithm to correct for hematocrit interference. The test process occurs in 5 seconds for prompt and accurate delivery of test results.
Abbott
(847) 937-6100; www.abbott.com
INSTRUMENTATION
Reflectance Lipid and Electrochemical Glucose Analyzer
WI-Fi capability transmits data results
Polymer Technology Systems Inc, Indianapolis, introduces the CardioChek 
Plus analyzer. It is a combination reflectance lipid and electrochemical glucose analyzer that delivers rapid test results for lipids and glucose simultaneously. The system has WI-Fi capabilities and can transmit patient results to data-collection applications. It can provide a glucose result, a calculated LDL measurement, a non-HDL calculated measurement, an LDL/HDL ratio, and a total cholesterol (TC)/HDL ratio simultaneously with a simple fingerstick blood sample, while offering important total cholesterol, HDL cholesterol, and triglycerides values at the same time.
Polymer Technology Systems Inc
(317) 870-5610; www.cardiocheck.com
Automated Hematology Analyzer
Offers three-part differential analyzer portfolio
Sysmex America Inc, Lincolnshire, Ill, introduces a new hematology offering—the Sysmex XP-300 
Automated Hematology Analyzer. The newest member of the company’s three-part differential analyzer portfolio combines the reliability and heritage of the KX-21N with updated, user-friendly software. It features a color touch-panel for convenient operation and time-saving bar code scanning, and is capable of storing up to 40,000 samples. A big update for smaller hospitals, clinics, and office-based labs, the system provides access to the known reliability of the company’s hematology analyzers.
Sysmex America Inc
(847) 996-4500; www.sysmex.com
Cellular Analysis System
New software saves time
The new UniCel DxH 600 Coulter Cellular Analysis System 
from Beckman Coulter, Brea, Calif, saves time by reducing overall manual review rates and processes. It has the same technology, user interface, advanced software, and consumables as the UniCel DxH 800. The software saves time by allowing labs to partially release patient results manually or automatically via decision rules. Users now have the ability to create and edit decision rules during instrument operation and use predefined decision rules via Cell Population Data.
Beckman Coulter Inc
(800) 526-3821; www.beckmancoulter.com
Automation Solution for Smaller Labs
Supports customized testing mix
Siemens Healthcare Diagnostics, Tarrytown, NY, expands its clinical laboratory automation portfolio with 
the VersaCell X3. The newest model of the VersaCell System offers the benefits of automation without the space or budget considerations of a track-based solution. It supports a customized mix of chemistry, immunoassay, and/or integrated systems and associated assay menus. A priority drawer situated above existing routine sample drawers provides eight new STAT positions and frees up
50 sample positions for routine processing. Modifications to the instrument’s signature robotic arm also enable it to support both rounded and flat-bottom tubes.
Siemens Healthcare Diagnostics
(888) 826-9702; www.medical.siemens.com
TESTING/DIAGNOSTICS
Cervical Cancer Test
Tests combination of genetic markers
Cancer Genetics Inc, Rutherford, NJ, introduces its proprietary cervical cancer test, the FISH-based 
HPV-Associated Cancer Test (FHACT). It uses a combination of genetic markers to detect genetic abnormalities located at 3q, 5p, 20q, and chromosome 7. A recent study concluded that these four biomarkers are associated with the severity of cervical lesions. The test can be performed directly on a Pap smear or liquid based-cytology and does not require any resampling.
Cancer Genetics Inc
(888) 334-4988; www.cancergenetics.com
IVD assay
Analyzes CYP2D6 genotype
Luminex Corp, Austin, Tex, has received FDA clearance for a new version of xTAG CYP2D6 Kit. The kit is an in vitro 
diagnostic assay that analyzes a patient’s CYP2D6 genotype from DNA extracted from a blood sample to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product. The assay runs on the Luminex 100/200 instrument. This new version of the kit optimizes performance on the 17 allele and features an updated software algorithm that detects all 17 genotypes the assay is cleared for, including deletion and duplication genotypes.
Luminex Corp
(888) 219-8020; www.luminexcorp.com
Immunoassay Improves Tacrolimus Monitoring
Provides low-end sensitivity
The QMS Tacroliums Immunoassay from Thermo Fisher Scientific, Waltham, Mass, is designed to 
improve monitoring of the immunosuppressant drug tacrolimus. The liquid, ready-to-use immunoassay kit has attained FDA 510(k) clearance for clinical use among kidney, liver, and heart transplant patients receiving tacrolimus therapy. Based on the Thermo Scientific Quantitative Microsphere Systems (QMS), a homogeneous particle-enhanced turbidimetric technology, the QMS Tacrolimus Reagent kit provides improved low-end sensitivity to aid physicians in monitoring patients on multiple drug therapies.
Thermo Fisher Scientific Inc
(800) 766-7000; www.thermofisher.com
Myocardial Infarction Assay
Large clinical trial proves precision, sensitivity
The Access AccuTnI+3 assay from Beckman Coulter, Brea, 
Calif, aids in the diagnosis of myocardial infarction (MI). In accordance with the FDA’s new requirements, Beckman Coulter conducted a large multicenter prospective clinical trial on the assay that enrolled more than 1,900 subjects, and confirmed that it provides the clinical performance needed for optimal patient management. The data from this trial confirms the assay delivers the precision, clinical sensitivity, and clinical specificity necessary to assist physicians with the diagnosis of MI.
Beckman Coulter Inc
(800) 526-3821; www.beckmancoulter.com
25-OH Vitamin D Assay
Simple pretreatment step
Gold Standard Diagnostics Corp, Davis, Calif, has received FDA 510(k) clearance for its 25-OH Vitamin 
D, Total ELISA. The assay strongly correlates with established LC/MS, EIA, and chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay features a simple pretreatment step that allows for complete automation on virtually any open ELISA processor. Because of the pretreatment step and automation capability, the assay provides fast and consistent results.
Gold Standard Diagnostics Corp
(530) 759-8000; www.gsdx.us
Prostate Cancer Blood Test
More specific than PSA alone
Beckman Coulter, Brea, Calif, introduces phi, a new, simple, 
noninvasive blood test for improved prostate cancer detection. It is 2.5 times more specific in detecting prostate cancer than PSA testing alone. This specificity allows for a substantial decrease in the number of prostate biopsies that are negative for cancer.
Beckman Coulter Inc
(800) 526-3821; www.beckmancoulter.com
Hemoglobin A1c Verification
Five-level assayed linearity material
The A1c-Cellular Linearity from Streck, Omaha, Neb, is a Hemoglobin A1c (HbA1c) linearity/calibration 
verification material with intact red blood cells. It is a five-level assayed linearity material used to assess instrument accuracy and verify the patient-reportable range of the HbA1c parameter. It is now assayed for the Roche cobas c 311. The formulation does not require reconstitution. The linearity material tests the entire reportable range of the instrument system, including the lyse step. Instrument-specific target values and expected ranges are provided for immediate instrument accuracy verification.
Streck
(800) 228-6090; www.streck.com
Test Detects vanA and vanB Genes
Obtains results for 46 samples in 3 hours
Abbott, Abbott Park, Ill, introduces a new molecular diagnostic test to detect the presence of vanA and 
vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The FDA-cleared IMDx VanR for Abbott m2000 test, which is performed on the company’s RealTime m2000 molecular diagnostics system, allows labs to obtain results for up to 46 patient samples in less than 3 hours, and up to 94 patient samples in less than 4 hours. The test is performed on human perirectal swabs, rectal swabs, or stool specimens from patients at risk for VRE colonization.
Abbott
(847) 937-6100; www.abbott.com
Control Consolidates Routine Cardiac Markers
Extends use of product to ER/ICU
The MAS Omni•CARDIO control from Thermo Fisher Scientific Inc, Waltham, Mass, consolidates routine 
cardiac markers, including troponin I and T, CK-MB, myoglobin, NT-proBNP, and BNP-32, with several new cardiac/STAT markers, including myeloperoxidase, hCG, D-dimer, and procalcitonin. These new analytes extend the use of the control into the ER/ICU hospital setting. It offers five control levels—the available ultra low and low options offer specific troponin I and T low-level challenges, which are increasingly demanded by clinical labs.
Thermo Fisher Scientific Inc
(800) 766-7000; www.thermofisher.com
Multianalyte, Lyophilised Control
Contains nine complex immunoassays
The FDA has approved the Acusera Immunoassay Specialty 1 control 
from Randox Laboratories, Kearneysville, WVa, for use in US labs. A multianalyte, lyophilised control, it contains nine complex immunoassays: I-25-(OH)2–Vitamin D, Insulin, Insulin Like Growth, Factor 1, 25-OH-Vitamin D, Peptide, Parathyroid Hormone, Procalcitonin, and Anti-Thyroglobulin. It is an assayed quality control that is suitable for use with most immunoassay analyzers, and contains clinically relevant levels of vitamin D.
Randox Laboratories
(866) 472-6369; www.randox.com
Aptima HPV assay
Detects 14 high-risk strains
The FDA has approved the Aptima HPV assay from Gen-Probe, now a part of Hologic Inc, Bedford, 
Mass. The assay is designed for use on the fully automated Panther system. The test is performed with the company’s ThinPrep liquid cytology specimen and can be tested before and after it has been processed for cytology testing on the ThinPrep 2000 system. The HPV mRNA-based assay is a nucleic acid amplified test that detects 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions, and has demonstrated significantly improved specificity with no compromise in disease detection, according to the company.
Gen-Probe
(800) 523-5001; www.gen-probe.com
Rapid, Molecular TB Test
Detects whether the strain may be multidrug-resistant
Cepheid, Sunnyvale, Calif, has received FDA approval for its Xpert MTB/RIF test for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA. Results can be made available to clinicians in about 2 hours. Designed for use on the company’s GeneXpert Systems, the test also detects the presence of mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB).
Cepheid
(408) 541-4191; www.cepheid.com
Strip-Based Test for ß-Hydroxybutyrate
Delivers results in 80 seconds
EKF Diagnostics, UK, introduces the STAT-Site M ß-HB. The new quantitative strip-based test for ß-Hydroxybutyrate (ß-HB) provides a quick assessment of diabetic ketoacidosis (DKA), delivering results in less than 80 seconds.
EKF Diagnostics
+44 (0)29 20 710570; www.ekfdiagnostics.com
RealTime HIV-1 Assay
Now available on m2000
Abbott, Abbott Park, Ill, has received FDA approval to expand the use of its RealTime HIV-1 assay to run on Abbott’s mPlus. In April, Abbott introduced mPlus capability for its RealTime m2000 system to enhance the system’s flexibility and make molecular testing easier and more efficient for labs. The new mPlus makes it possible for labs of any size to perform molecular diagnostic tests for infectious disease detection and therapy monitoring. mPlus capability is now available for Abbott’s RealTime HIV-1 and CT/NG assays within the United States.
Abbott
(847) 937-6100; www.abbott.com
Companion Diagnostic for NSCLC
IDs EGFR mutation-positive patients
The FDA has approved Gilotrif (afatinib) from Qiagen Inc, Germantown, Md, for treatment of metastatic non-small cell lung cancer (NSCLC) along with the companion diagnostic, therascreen EGFR RGQ PCR kit. The therascreen EGFR test helps physicians identify EGFR mutation-positive patients eligible for treatment with Gilotrif.
Qiagen Inc
(800) 426-8157; www.qiagen.com
