Tabletop Molecular Testing System
Requires less than 10 minutes of hands-on time
The Viper LT from BD, Franklin Lakes, NJ, is a fully automated tabletop molecular testing system. Delivering true walkaway capability, the system requires less than 10 minutes of hands-on time per run, and performs automated onboard sample DNA extraction. It offers connectivity to laboratory information systems, and supports reagent and consumable checks that identify potential errors prior to runs. Other features include ready-to-use reagents, sample tubes with pierceable caps to avoid manual opening, and room temperature reagent storage. The system has a moderate complexity categorization under the Clinical Laboratory Improvement Amendments of 1988.
(800) 638-8663; www.bd.com
Benchtop Sequencing System
Performs onboard data analysis
Illumina Inc, San Diego, recently launched the MiniSeq sequencing system, a benchtop device with push-button operation. The system enables a broad range of DNA and RNA sequencing applications, from examining single genes to entire pathways, in a single run. The sequencer is designed as part of a complete sequencing system that enables both experienced and new-to-next-generation-sequencing researchers to get results quickly with a library-to-results workflow and onboard data analysis for numerous assays. The device is also able to stream sequencing data to BaseSpace, Illumina’s cloud and onsite genomics computing environment. For research use only.
(858) 202-4500; www.illumina.com
Digital PCR System
Partitions a DNA or RNA sample into 20,000 droplets
The QX200 droplet digital polymerase chain reaction (ddPCR) system from Bio-Rad Laboratories Inc, Hercules, Calif, is the first such system to receive CE marking for use as an in vitro diagnostic in the European Union. The system offers accurate detection and quantification of nucleic acids, aiding clinical decisionmaking for the treatment of diseases ranging from cancer to transplant rejection and viral infection. The technology partitions a DNA or RNA sample into 20,000 droplets and amplifies targeted sequences within each droplet, allowing scientists to detect and quantify low concentrations of target DNA and RNA sequences with precision. Genomic applications include cancer mutation detection, gene copy number determination, viral load monitoring, and gene edit detection. For research use only.
(800) 424-6723; www.bio-rad.com
Infectious Disease Detection
System offers isothermal amplification
The Alere i from Alere Inc, Waltham, Mass, is a rapid, instrument-based system for the qualitative detection of infectious diseases. The company’s nicking enzyme amplification reaction (NEAR) technology uses enzymes to drive the amplification process, and works at a single constant temperature. Because it does not require lengthy and complex thermocycling or DNA purification, NEAR technology can deliver polymerase chain reaction-caliber results in just minutes. The device includes a visual touchscreen with no separate instructions. A large screen displays results, seeking to eliminate transcription errors. The system offers unidirectional connectivity to the user’s network. The platform can run tests for the detection of group A Streptococcus, and influenza A and B.
(877) 441-7440; alere-i.com
Produces results in about 2 hours
Great Basin Scientific Inc, Salt Lake City, has received FDA premarket notification (510(k)) clearance for its Staph ID/R blood culture panel, the company’s first multiplex panel to receive FDA clearance. The panel is a sample-to-result, automated, multiplex DNA assay for simultaneous identification of Staphylococcus aureus and other Staphylococcus species directly from positive blood cultures in about 2 hours. Requiring less than 1 minute of hands-on time, the panel also detects the mecA gene, a major drug-resistance marker that confers resistance to methicillin and other beta-lactams and creates the superbug methicillin-resistant Staphylococcus aureus. The multiplex panel is run on the company’s analyzer, which also performs the company’s commercially available lowplex tests for Clostridium difficile and Group B Streptococcus, as well as the company’s standalone molecular test for the detection of Shiga toxin-producing E. coli.
Great Basin Scientific
(888) 360-4022; gbscience.com
STI Multiplex Array
Simultaneously detects 10 bacterial, viral, and protozoan infections
The sexually transmitted infection (STI) multiplex array from Randox Laboratories, Crumlin, UK, simultaneously detects 10 bacterial, viral, and protozoan infections, including primary, secondary, and asymptomatic coinfections for a complete infection profile. The assay is based on a combination of multiplex polymerase chain reaction (PCR) and biochip array hybridization. PCR priming technology permits high discrimination between multiple targets. A unique primer set is designed for each target, which will hybridize to a complementary oligonucleotide probe spotted on the discrete test region of a biochip. The combination of priming and spatially organized biochip array technology enhances the specificity of the assay. Analysis can be completed from template DNA through PCR to data readout in 6 hours. The array is CE marked for routine clinical use.
(866) 472-6369; www.randox.com
Gene Expression Classifier
Identifies benign thyroid nodules
The Afirma gene expression classifier (GEC) from Veracyte, South San Francisco, Calif, helps reduce the number of unnecessary surgeries related to thyroid cancer diagnoses. The 142-gene test identifies benign thyroid nodules among those deemed indeterminate by cytopathology, so that patients can avoid diagnostic surgery. An additional 25 genes are used to differentiate uncommon neoplasm subtypes. Findings from a prospective, multicenter study published in the New England Journal of Medicine showed the Afirma GEC’s sensitivity is 92% and its negative predictive value is greater than 94%. The test is recommended in leading clinical practice guidelines, including those of the American Thyroid Association and the National Comprehensive Cancer Network. Additionally, the company’s Afirma malignancy classifiers—comprising tests for medullary thyroid cancer and BRAF gene mutation status—are designed to inform surgical strategy for those patients headed to surgery based on their cytopathology or Afirma GEC results.
(888) 923-4762; www.veracyte.com
Automates nucleic acid testing
A fully automated sample-to-result instrument, the Panther system from Hologic, Marlborough, Mass, automates all aspects of nucleic acid testing on a single, integrated platform. It eliminates the need for batch processing and combines walkaway freedom with intuitive design for ease of use. Assays available for use in Canada, Europe, and the United States include the Aptima Combo 2 assay for chlamydia and gonorrhea, the Aptima Trichomonas vaginalis assay, and the Aptima human papillomavirus assay, which can also be combined with Papanicolaou testing for cervical cancer screening. The Aptima viral load assays for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus 1 are currently available in Europe, and are in development for the United States. In addition, development of a second-generation assay for early detection of prostate cancer is under way.
(781) 999-7453; www.hologic.com
Epithelial Cancer Tests
Identifies targetable DNA mutations
ClearID and NK Vue from Cynvenio Biosystems, Westlake Village, Calif, are complementary tests that can be used together in making clinical decisions when monitoring patients for detection or recurrence of epithelial cancer. ClearID identifies targetable DNA mutations to inform treatment paths. Using ClearID genomic testing, physicians can assess patients’ individual mutations and match them with targeted cancer therapies and clinical trials. ClearID is low risk and easily repeatable, requiring only a standard blood sample, and is the only commercial test to interrogate both circulating tumor cell DNA as well as cell-free DNA. NK Vue measures the activity of NK cells and monitors immune system health. Although low NK cell activity does not indicate a disease or an illness, it can indicate the health of the immune system and alert physicians when more aggressive surveillance is required, or trigger additional testing.
(805) 777-0017; www.cynvenio.com
Molecular Diagnostics System
Increases laboratory efficiency
The Aries molecular diagnostics system from Luminex, Austin, Texas, is a sample-to-answer real-time polymerase chain reaction system that is crafted to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into Lean laboratory environments. The system uses internal barcode scanning to minimize operator errors. Two independent modules each support from one to six cassettes. As a result, the system can run stat and batch-testing in vitro diagnostics and MultiCode analyte-specific reagents simultaneously, using a common universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, thus maximizing bench space. The system recently received FDA premarket notification (510(k)) clearance, along with a proprietary assay for herpes simplex virus 1 and 2.
(866) 401-5450; www.luminexcorp.com
Integrated PCR, NGS Platform
Supports more than 60 validated applications
Vela Diagnostics, Fairfield, NJ, offers both real-time polymerase chain reaction (rtPCR) and next-generation sequencing (NGS) applications to test for infectious diseases and oncology targets on a single integrated platform. With more than 60 validated applications, Vela offers more than 28 PCR tests, five NGS panels for 19 different sample types, and open-channel capabilities. All data are automatically analyzed and quality controlled by Sentosa Reporter software, which provides users with a comprehensive automatically generated report.
(973) 852-3740; www.veladx.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 Healthineers, 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.
(800) 242-3233; www.healthcare.siemens.com
Breast Cancer Test
Delivers unambiguous result
Agendia, Irvine, Calif, has received FDA premarket notification (510(k)) clearance for the MammaPrint breast cancer recurrence test in formalin-fixed paraffin-embedded (FFPE) tissue. The MammaPrint FFPE test utilizes the same 70 genes and proprietary algorithm as the previously cleared MammaPrint Fresh, a multigene medical device that uses microarray technology to analyze a patient’s breast tumor biology to predict whether existing cancer has the ability to metastasize. Both tests provide an unambiguous result of “low risk” versus “high risk’” for recurrence of a patient’s breast cancer. This capability applies across all age groups, and is not restricted by estrogen or HER 2 receptor status. The additional insight about the cancer’s biology enables physicians to choose the best treatment for their patients. MammaPrint has substantial insurance coverage, including by Medicare and regional and national insurers.
(888) 321-2732; www.agendia.com/
Multiplex PCR System
Requires 2 minutes of hands-on time
BioFire Diagnostics LLC, Salt Lake City, has received FDA premarket notification (510(k)) clearance to market its FilmArray Torch instrument for use with the FilmArray blood culture identification panel, gastrointestinal panel, and meningitis/encephalitis panel. Earlier this year, the system received FDA clearance for use with the FilmArray respiratory panel. The high-throughput system is a fully integrated, random, and continuous access multiplex polymerase chain reaction system designed to meet the throughput demands of any size clinical laboratory. Integrating sample preparation, amplification, and detection into a single closed system, the system requires only 2 minutes of hands-on time and has a total run time of about an hour.
(800) 735-6544; www.biofiredx.com