Strep A Test
Delivers results in 8 minutes or less
The Alere i Strep A test from Alere, Waltham, Mass, detects group A Streptococcus bacteria from throat swab specimens in 8 minutes or less. Operating on the company’s Alere i platform, the isothermal nucleic acid technology amplifies at a constant temperature. Because thermal cycling and sample purification steps are not required, the test produces fast results. A multicenter study demonstrated that the test’s sensitivity is 95.9% while its specificity is 94.6% The kit features a compact footprint, intuitive touchscreen, visual guides, and unidirectional connectivity to the user’s network. The company’s platform can also run a CLIA-waived Alere i influenza A and B test, which detects and differentiates influenza A and B virus in less than 15 minutes.
Alere
(781) 647-3900; www.alere.com
Real-Time PCR Platform
Offers on-demand stat testing
Automating the entire testing process, from sample prep to amplification to real-time detection, the Cobas Liat system from Roche Diagnostics USA, Indianapolis, includes a small benchtop analyzer, an extensive array of instrument controls, and assay tubes for specific targets. The Cobas Liat analyzer compresses the assay tube to release reagents selectively from tube segments. Samples can be transferred from one segment to another, while reaction conditions can be controlled at different temperatures. As a secure and fully closed system, the system reduces the risk of cross-contamination and preserves sample integrity. Definitive, objective results are produced in 20 minutes or less. Featuring touchscreen-guided operation with minimal hands-on time, the platform can be used for the company’s Streptococcus group A and influenza A and B nucleic acid tests.
Roche Diagnostics USA
(800) 428-5076; usdiagnostics.roche.com
Melanoma Test
Detects 23 unique biomarkers
Myriad myPath melanoma from Myriad Genetics, Salt Lake City, is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. The assay, which detects 23 unique biomarkers, has demonstrated high sensitivity and specificity in multiple independent cohorts. In a verification study using 464 patient samples and a separate independent validation study with 437 patient samples, the test demonstrated diagnostic accuracy greater than 90%. Acceptable samples are formalin-fixed, paraffin-embedded tissue from blocks or slides of melanocytic lesions. The assay is adjunctive and should be used in conjunction with clinical data and a pathologic work-up.
Myriad Genetics
(801) 584-3600; www.myriadpro.com/melanoma
Random Access Analyzer
Platform performs respiratory virus and cystic fibrosis panel tests
GenMark Diagnostics Inc, Carlsbad, Calif, enables clinical laboratories to process multiple test types simultaneously with its eSensor XT-8 molecular diagnostics system. The instrument features a touchscreen user interface, customizable reports, and an expanding menu of multiplex in vitro diagnostic tests that can all be addressed on the same platform. The company’s respiratory virus panel requires less than 60 minutes of hands-on preparation time, including DNA extraction, and detects 14 respiratory virus types and subtypes after just over 3 hours of walk-away time. The company’s cystic fibrosis genotyping panel detects 23 mutations for which testing is recommended by the American Congress of Obstetricians and Gynecologists and the American College of Medical Genetics and Genomics. The cystic fibrosis panel requires 40 minutes of hands-on preparation time, and produces test results in approximately 3 hours. In clinical trials, the panel had 100% accuracy and reproducibility, and a 97.3% first-pass call rate.
GenMark Diagnostics
(800) 373-6767; genmarkdx.com
Postnatal Blood Test
Assists in diagnostic evaluation of intellectual disability
The CytoScan Dx assay from Affymetrix, Santa Clara, Calif, is a chromosomal microarray test to aid physicians in the diagnostic evaluation of congenital abnormalities, developmental delay, dysmorphic features, and intellectual disability in children. Including 2.69 million functional markers across the entire genome, the assay is intended for postnatal detection of chromosomal copy number variants in genomic DNA obtained from peripheral whole blood of patients referred for chromosomal testing based on clinical presentation. Equipped with both copy number and single-nucleotide polymorphism probes, the test can elucidate allelic imbalances and identify loss of heterozygosity and absence of heterozygosity associated with uniparental disomy or consanguinity, two conditions that increase the risk of recessive disorders. The assay also improves diagnostic yield by an incremental 12.5%, producing more accurate diagnosis when compared to G-banded karyotype. The assay can be analyzed using the company’s chromosome analysis suite Dx software, which offers an intuitive graphical interface.
Affymetrix
(888) 362-2447; www.affymetrix.com
Tissue Preparation System
Extracts nucleic acids from FFPE and FF tissues
Using magnetic particle-based isolation and proprietary iron oxide bead technology, the tissue preparation solution from Siemens Healthcare Diagnostics Inc, Tarrytown, NY, incorporates both a tissue preparation system and Versant tissue preparation reagents. The system provides a fully automated method of isolating high-quality nucleic acids from formalin-fixed, paraffin-embedded and fresh-frozen tissues. Processing up to 48 samples in 4 hours, the system eliminates the use of organic solvents and centrifugation steps associated with deparaffinization. DNA and RNA can be extracted together using a single process with one set of reagents. Users have multiple options for protocols: total nucleic acid for DNA applications, pure RNA for RNA applications, or a combined analysis of DNA and RNA from one sample. Labs can benefit from a uniform lysis step of 1 hour for all samples, thereby optimizing reproducibility.
Siemens Healthcare Diagnostics
(800) 242-3233; www.healthcare.siemens.com
Oncology Hotspot Control
Includes cancer-associated mutations across 53 genes
Serving as a control for assays involving more than 500 hotspot mutations, the AcroMetrix oncology hotspot from Thermo Fisher Scientific, Waltham, Mass, can be used across laboratories with different next-generation sequencing platforms, assays, and bioinformatics pipelines. Containing both synthetic and genomic DNA, the control tests precision and detects analytical deviations that may emerge from variations among reagents and instruments. It encompasses cancer-associated mutations across 53 genes, including BRAF, EGFR, ERBB2, KRAS, and TP53. Users can select from 3 complex mutations, 18 insertions, 29 deletions, and 500 single nucleotide variants. The control has a validated shelf life of 12 months at –20°C and is stable over five freeze-thaw events.
Thermo Fisher Scientific
(800) 678-5599; www.thermofisher.com
Herpes Simplex Virus Assay
Amplifies target regions within HSV 1 and 2 genomes
The Artus herpes simplex virus 1 and 2 QS-RotorGene Q MDx from Qiagen, Valencia, Calif, is a ready-to-use system for the detection and differentiation of herpes simplex virus 1 and 2 (HSV) DNA using real-time polymerase chain reaction on the company’s QiaSymphony sample preparation and assay setup instruments. The kit contains reagents and enzymes for amplifying specific target regions within the HSV 1 and HSV 2 genomes. It also can directly detect the specific amplicon in fluorescence channels cycling orange and cycling green on the RotorGene Q MDx. Detected as an internal control in the fluorescence channel cycling crimson on the instrument, a second heterologous control system locates potential failures during the assay process. The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients. It is not cleared for use with cerebrospinal fluid or for prenatal screening. Human oral and genital lesion swabs should be collected in M4RT or universal transport media.
Qiagen
(800) 426-8157; www.qiagen.com
MicroRNA Gene Expression Classifier
Uses the expression levels of 10 miRNAs
Interpace Diagnostics, Parsippany, NJ, has released ThyraMir, a microRNA gene expression classifier that identifies indeterminate benign and malignant thyroid nodules from thyroid nodule fine needle aspiration procedures. In conjunction with the company’s ThyGenX genetic mutation panel, which identifies more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the test achieves a negative predictive value of 94% and positive predictive value of 74% at a cancer prevalence of 32%. Using the expression levels of 10 miRNAs, the test has a specificity of 85% and a sensitivity of 89%.
Interpace Diagnostics
(844) 405-9655; interpacediagnostics.com
Multiplex PCR System
Processes 175 samples in one day
The FilmArray system from BioFire Diagnostics, Salt Lake City, is a multiplex polymerase chain reaction system that integrates sample preparation, amplification, detection, and analysis. Testing up to 175 samples per day, the system offers single database management of 8 instruments, bringing about high throughput with random access. Users can choose from respiratory, blood culture identification, and gastrointestinal panels, which all together test for more than 100 pathogens. The panels require 2 minutes of hands-on time, with a turnaround time of approximately 1 hour. No precise measuring or pipetting is required. The compact system also features laboratory information system connectivity.
BioFire Diagnostics
(800) 735-6544; www.biofiredx.com
Enteric Pathogens Test
2-hour run time
An automated, multiplexed molecular diagnostic test, the Verigene enteric pathogens test from Nanosphere, Northbrook, Ill, simultaneously detects and identifies common pathogenic enteric bacteria, viruses, and genetic virulence markers. Negative stool samples, preserved in Cary-Blair media, are confirmed in approximately 2 hours, with 5 minutes of hands-on time. Targets include Campylobacters, Salmonella, Shigella, Vibrios, and Yersinia enterocolitica bacteria, Shiga toxins 1 and 2, norovirus, and rotavirus. The test is run on the Verigene reader and processor SP, a benchtop analyzer that combines automated nucleic acid extraction, purification, amplification, and hybridization in each module. In addition to minimizing unnecessary downstream testing, results may improve patient management decision-making and prevent use of inappropriate or unnecessary drugs.
Nanosphere
(888) 837-4436; www.nanosphere.us
Sex-Specific Blood Test
For the evaluation of obstructive coronary artery disease
The Corus coronary artery disease (CAD) test from CardioDx Inc, Redwood City, Calif, incorporates age, sex, and gene expression measurements into a single score that indicates the likelihood of the condition. Along with other clinical information, physicians can use the CAD score to assess the need for further cardiac testing. In prospective, multicenter studies, the test demonstrated a sensitivity of 89% and a negative predictive value of 96%. Involving a routine blood draw, the test accounts for key cardiovascular differences between men and women and is intended for use in patients who present with stable symptoms suggestive of obstructive CAD. It is not intended for patients who have had a history of obstructive CAD or who have had prior myocardial infarctions or revascularization procedures. The test delivers objective, reproducible results within a few days.
CardioDx
(866) 941-4996; www.cardiodx.com
Real-Time Strep Assay
Moderate complexity test requires 50 ?L of sample
Eliminating the need for mixing and precision pipetting, the Simplexa Group A Strep direct kit from Focus Diagnostics, Cypress, Calif, directly detects group A Streptococcus from throat swabs collected in patients with signs and symptoms of pharyngitis. Using real-time polymerase chain reaction, the assay requires 50 ?L of sample and runs 1–8 samples per run. The test produces results in approximately 1 hour. In clinical studies, the assay demonstrated 97.4% sensitivity and 95.2% specificity, compared to culture. It is also categorized as moderate complexity, enabling some physician offices, community hospitals, health clinics, and integrated delivery networks to perform the test directly.
Focus Diagnostics
(800) 838-4548; www.focusdx.com
EMT Enrichment Kit
Targets cells with epithelial to mesenchymal properties
Fluxion Biosciences Inc, San Francisco, has introduced the IsoFlux epithelial to mesenchymal transition enrichment kit, for use on the company’s IsoFlux instrument. The kit isolates rare circulating tumor cells (CTCs), specifically cells with both epithelial and mesenchymal properties, from blood samples. Incorporating the epithelial cell adhesion molecular antibody, as well as a propriety combination of EMT-specific antibodies, the kit increases the overall capture of all types of CTCs. Offering a throughput of up to 12 samples per day, the IsoFlux instrument features a simple, benchtop design with touchscreen, without the need for external hookups or PC. EMT enrichment kits are available for immediate use through the IsoFlux discovery services program, while customers can receive shipments in the third quarter of this year.
Fluxion Biosciences
(866) 266-8380; fluxionbio.com
Saliva Purifying Collection Device
Collects two 0.5 mL saliva samples
The RNAProSal device from Oasis Diagnostics, Vancouver, Wash, removes cells and extraneous materials from saliva and provides two samples of highly purified saliva for downstream testing for microRNAs and mRNAs, as well as proteins for proteomics. While samples are generally obtained by bifurcation of a filtered sample, both samples may instead be combined for customers who are interested in testing for RNA only or specifically for proteins. This method achieves a larger sample volume for downstream analysis. Typical collection times range from 1 to 3 minutes, and two samples of approximately 0.5 mL of saliva are obtained. Stabilizing reagents are provided with the device, as needed. RNAProSal is available for research use only.
Oasis Diagnostics
(360) 546-1563; 4saliva.com
