ZnT8Ab ELISA Kit
Aids in the diagnosis of type 1 diabetes mellitus
Kronus, Star, Idaho, offers a zinc transporter 8 autoantibody (ZnT8Ab) enzyme-linked immunosorbent assay (ELISA) kit for the semiquantitative determination of autoantibodies to zinc transporter (ZnT8) in human serum. The kit is used as an aid in the diagnosis of type 1 diabetes mellitus, or autoimmune mediated diabetes. ZnT8 is a member of the large cation efflux family and is one of the major targets of type 1 diabetes autoimmunity. ZnT8 autoantibodies may be present in patients diagnosed with diabetes and are useful as a marker for type 1 diabetes testing.
(800) 457-6687; www.kronus.com
Blood Culture Assay Kit
Includes over 150 assays
The identification and antimicrobial susceptibility testing (ID/AST) system and blood culture assay kit from Accelerate Diagnostics Inc, Tucson, Ariz, is a fully integrated platform that provides high-speed ID/AST for pathogens directly from patient samples. According to the company, the platform has the potential to enable laboratories to provide critical results in hours instead of days. The kit is being investigated for its ability to provide ID/ AST results for patients suspected of bacteremia or fungemia, both life-threatening conditions with high morbidity and mortality risk. This first sample kit consists of a multiplexed panel of more than 150 individual assays, developed to support clinicians in prescribing optimal antibiotic therapy for patients with bloodstream infections. The company recently announced the initiation of its clinical trial for submission to FDA.
(520) 365-3100; acceleratediagnostics.com
Monitoring and Reporting Instrument
Offers continuous pH monitoring
Blood Cell Storage Inc, Seattle, has introduced the Safe Sens system, a monitoring, reporting, and logging lab instrument that controls from two to eight pH measurement servers installed inside incubators used in in vitro fertilization clinics. The system includes two different measurement device options, TrakStation and TrakPod, which both employ an optical, fluorescent pH measurement technology. Used in combination with disposable sensors, the technology accurately monitors the pH of small volumes of fluids. Each TrakStation can continuously monitor up to eight TrakPods in multiple large-format incubators or desktop chambers. Automatic measurements occur every 30 minutes without having to remove samples from the incubator. Data are graphed for visual display, stored locally, and can be saved to a USB drive for analysis on a PC.
Blood Cell Storage
(425) 654-8445; www.bloodcellstorage.com
ELISA Detects Circulating sTNFR1 Levels
Requires 50 µL of blood serum or plasma
The soluble tumor necrosis factor receptor 1 (sTNFR1) test from EKF Diagnostics, Cardiff, UK, is a microtiter plate, ELISA-based assay using monoclonal antibodies. The test detects circulating levels of sTNFR1 in patient samples in a few hours with minimal interference and cross-reactivity. Interfacing with standard laboratory equipment, the test can be performed with only 50 µL of blood serum or plasma. Recent data support sTNFR1 as a biomarker to predict progression of diabetic nephropathy, and suggest sTNFR1 can identify diabetic patients for inclusion in clinical trials of novel therapeutic interventions to prevent or delay progression to end-stage renal disease.
(800) 531-5535; www.ekfdiagnostics.com
Handheld Vital Signs Monitor
Includes miniature pulse oximeter
Developed by engineers and physicians at the Johns Hopkins University School of Medicine, MouthLab is a handheld, battery-powered device that picks up vital signs from a person’s lip and fingertip. The 3D-printed prototype includes a small, flexible mouthpiece that holds a temperature sensor and a blood volume sensor. The thumbpad on the handheld unit has a miniaturized pulse oximeter, which uses beams of light to measure blood oxygen levels. Other sensors measure breathing from the nose and mouth. The device also takes a basic electrocardiogram, and relays data by Wi-Fi to a nearby laptop or smart device, where graphs display real-time results. The next generation of the device will display its own data readouts without the need for a laptop.
Johns Hopkins University School of Medicine
(410) 955-5000; www.hopkinsmedicine.org
Blood Infection Diagnostic System
Delivers results in 2 to 3 hours
DNA Electronics Ltd (DNAe), London, recently received funds for the final development stages of a point-of-need test for serious blood infections. Applying the company’s Genalysis semiconductor DNA sequencing technology, the test aims to provide a complete blood-to-result diagnostic system, with actionable results in 2 to 3 hours. The test also leverages DNAe’s pathogen capture system technology, which uses a proprietary mixture of immunomagnetic beads that specifically and rapidly extract bacterial and fungal pathogens at low concentrations, eliminating the need for a time-consuming enrichment step. DNAe plans to continue clinical trials through 2016 and launch the test in 2017.
[email protected]; www.dnae.com
Single-Cell Isolation System
Isolates up to 1,800 single cells
The ICell8 system from WaferGen Bio-Systems Inc, Fremont, Calif, is designed to enhance single-cell research by isolating thousands of single cells of any type and size, and processing specific cells of interest for downstream analysis using next-generation sequencing. Consisting of hardware, software, and reagents, the single-cell system can consistently isolate up to 1,800 single cells per chip and also provide biological insight by investigating up to eight samples on a single chip. The system includes an imaging station that detects fluorescent dyes commonly used in single cell research, and interfaces directly with CellSelect software, which evaluates multiple parameters to determine the number of cells present and their viability.
(877) 923-3746; www.wafergen.com
BICD2 Protein Marker
Aids in diagnosis of systemic sclerosis
The recently launched Multilisa BICD2 test from Protagen AG, Dortmund, Germany, is an enzyme-linked immunosorbent assay that aids in the diagnosis of systemic sclerosis (SSc). The first proprietary marker out of the company’s SeroTag platform, the assay is intended for the semiquantitative determination of IgG antibodies specific to the BICD2 protein, an evolutionarily conserved motor adaptor protein involved in the dynein-mediated transport process. Anti-BICD2 autoantibodies are found in approximately 30% of patients with SSc. The autoantibodies are highly associated with the limited form of SSc and, behind such classic markers as anti-Centromere antibodies and anti-Scl70 antibodies, are the most abundant autoantibodies found in patients with SSc. For research use only.
[email protected]; www.protagen.com
Available in single- and multiplex formats
Horizon Discovery Group plc, Cambridge, UK, has introduced cell-free DNA (cfDNA) HDx reference standards. The standards support the development and optimization of cfDNA assays, which are emerging as important tools for noninvasive liquid biopsies. Created from engineered cell lines, the standards are available in both singleplex and multiplex format, with cancer-relevant mutations for genes that include BRAF, EGFR, KRAS, NRAS, and PIK3CA. The standards consist of human genomic DNA fragmented to 160 bp, representative of plasma-derived cfDNA, and are provided as a set of precisely defined allelic frequencies from as low as 0.1%. A matched wild type is included. Reference standards with further genetic variants are currently under development.
Horizon Discovery Group
(844) 655-7800; www.horizondiscovery.com
Automated Molecular Testing System
Uses fully enclosed cartridge
The Encompass MDx and Encompass Optimum platforms from Rheonix Inc, Ithaca, NY, are automated systems that streamline workflow for building and implementing molecular assays. Using the Rheonix chemistry and reagent device (CARD) cartridge, researchers can create their own sample-to-answer, fully automated, complex molecular assays. The CARD permits all assay steps to be performed within a fully enclosed cartridge, thus eliminating the potential for contamination, reducing user error, and streamlining workflow. By actively pumping fluids from reservoir to reservoir within the CARD, molecular diagnostic tests can be performed automatically. The Encompass Optimum is for research use only.
(607) 257-1242; www.rheonix.com
Minimal Residual Disease Detection System
For patients with lymphoid cancers
The ClonoSeq secure portal from Adaptive Biotechnologies, Seattle, enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as an aid in the treatment of patients with blood cancers. The company’s ClonoSeq MRD test detects cancer cells at a level as low as one per one million white blood cells. The process involves two steps: first, the ClonoSeq ID test identifies cancer cell DNA sequences in a diagnostic sample, and then the ClonoSeq MRD test screens follow-up samples for the previously identified sequences in order to detect MRD. Results showing a patient’s MRD status and level, as well as trends over time, are delivered in a simple, actionable report via a secure online portal.
(855) 466-8667; www.adaptivebiotech.com
Portable DNA Sequencing Tool
Streams data in real time
The MinIon sequencer from Oxford Nanopore Technologies, Oxford, UK, is a pocket-sized gene-sequencing instrument that plugs directly into a PC or laptop computer’s USB port. No additional computing infrastructure is needed. The portable device works with consumable flow cells that contain the proprietary nanopore-sensing apparatus required to perform experiments. The system is designed to be compatible with complex samples, such as blood or serum, and environmental samples, such as water samples. Data are streamed in real time. Currently available for the analysis of nucleic acids, the device is available to use after paying an access fee of $1,000.
Oxford Nanopore Technologies
[email protected]; nanoporetech.com
Lung Cancer Test
For early detection
Randox Laboratories, Crumlin, UK, and Biosystems International, Debrecen, Hungary, recently commenced validation of a lung cancer early detection test. Involving more than 1100 samples, a clinical trial has been carried out in partnership with BioDiagnostica Kft, Budapest, Hungary, across four lung cancer treatment centers in Hungary. According to the companies, the study has already produced promising results, with Biosystems International’s mAb libraries proving to be valuable for detecting both qualitative and quantitative variability of the proteome in cancer. The partners are looking toward validating the test to bring it to market and have signed a licensing agreement that enables Randox to distribute the test globally.
(866) 472-6369; www.randox.com
Handheld DNA Amplification System
Promises to deliver sub-15-minute sample to result
XCR Diagnostics, Park City, Utah, a new wholly owned subsidiary of Fluoresentric, Park City, Utah, is harnessing the power of Xtreme Chain Reaction (XCR) chemistry technology from its parent company to launch a handheld diagnostic system. Currently in prototype stages, the patent-pending instrument promises to deliver clinically actionable results at the point of care in less than 15 minutes. XCR is an ultra-fast DNA/RNA amplification method and assay design technology that is reported to be five to 10 times faster than traditional polymerase chain reaction.
(800) 808-0490; fluoresentric.com
Advanced Blood Test
Measures expression levels of 12 biomarkers
The US Patent and Trademark Office has issued a patent for the Vectra DA test by Crescendo Bioscience, San Francisco, a wholly owned subsidiary of Myriad Genetics, Salt Lake City. The patent, which is expected to expire in 2031, provides intellectual property protection for the advanced blood test for adults with rheumatoid arthritis (RA). Helping patients objectively track their disease activity over time, Vectra DA measures expression levels of 12 biomarkers that are combined into a single score. The biomarkers include CRP, EGF, IL-6, leptin, MMP-1, MMP-3, resistin, SAA, TNF-RI, VCAM-1, VEGF-A, and YKL-40. The recently issued patent is coassigned to Crescendo and the Oklahoma Medical Research Foundation, and is the first patent issued relating to Vectra DA.
(650) 351-1354; www.crescendobio.com