54 New CE-IVD NGS Test and Analysis Software for Use in Clinical Labs
Next-generation sequencing (NGS) is quickly becoming the platform of choice for tumour molecular profiling due to its ability to simultaneously report on multiple biomarkers. However, lengthy turnaround times can limit the clinical utility of these results. To meet the need for rapid genomic insights, Thermo Fisher Scientific has launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical labs.
Using targeted NGS technology, the Oncomine Dx Express Test delivers clinically relevant tumour mutation profiling in as little as 24 hours to aid healthcare professionals, in accordance with professional guidelines, in therapy management of cancer patients. The qualitative in vitro diagnostic (IVD) test detects deletions, insertions, substitutions and copy number gain present in 42 genes and fusions or splicing variants in 18 genes from DNA and RNA in FFPE tumour tissue samples of solid malignant neoplasms. This assay also detects deletions, insertions, substitutions in 42 genes and fusions or splicing variants in seven
genes from cfTNA extracted from plasma samples of non-small cell lung cancer (NSCLC). The assay requires minimal sample input, maximising sample success rates.
The Oncomine Reporter Dx software ensures healthcare providers can quickly assess the genomic test results. The software matches the variant data to relevant evidence including approved therapies, guidelines, clinical trials and peer reviewed literature in a user-friendly and customisable report.
The new NGS assay and genomic reporting software, along with the recently launched Ion Torrent Genexus Dx Integrated Sequencer, offer an automated end-to-end CE-IVD workflow. Operated from a single software interface, the overall process includes less than 20 minutes of hands-on time, delivering results with unprecedented rapid turnaround time. The workflow enables any lab to bring the power of genomic testing in-house, improves access to patients and advances precision oncology for those who stand to benefit most.
More information online:
ilmt.co/PL/PxzP 58740pr@reply-direct.com First Enterprise SaaS LIMS - Pre-Validated for Regulated Industries
LabVantage Solutions offers the first enterprise software-as-a-service (SaaS) LIMS to accommodate the needs of more complex organisations. LabVantage Enterprise SaaS exceeds in offering full configurability and customer interfacing support that enable modifications, even as customer requirements change over time. It supports interfacing with external software systems and adding features specific to the needs of customers.
The enterprise edition, hosted in a single-tenant cloud environment, includes a managed and monitored computing infrastructure, automatic software upgrades, and enterprise-grade features. In addition, it can be pre-validated for use in regulated environments, offering evidence of installation qualification, testing, and change control.
For a guide to SaaS LIMS, read the white paper. More information online:
ilmt.co/PL/j6O6
Cell-permeable Small Molecules for Regenerative Medicine and Cancer Research
AMSBIO offers a wide range of small molecules to provide scientists with targeted tools to direct cell fates, making them crucial in areas including regenerative medicine and cancer research.
Small molecules are cell-permeable organic compounds with low molecular weights, which are chemically produced, in contrast to larger molecules such as proteins which are often produced via biological means. Small molecules are crucial components of an affordable cell culture toolkit that can be used to maintain, reprogram, and differentiate cells.
Typically, small molecules are cost-effective: rapid and convenient to manufacture with a high level of purity and low batch to batch variation, ensuring consistent activity and reproducible results. Producing larger molecules by biological means such as using viral vectors has the potential to introduce unwanted genetic material. By comparison animal-free small molecules are inherently safe, eliminating this possibility.
Used as tools to manipulate cell fates via the targeting of signalling pathways, small molecules are increasingly being cited in regenerative medicine research: to direct cells down a certain developmental pathway to a desired cell type, to reprogram somatic cells into pluripotent cells and to maintain cells in culture. In cancer research, a wide range of small molecules are being used in targeted cancer therapy, to target the specific genes and proteins in cancer cells that enable them to survive and grow.
AMSBIO offer an extensive portfolio of high purity small molecules ranging from A83-01, Cyclopamine and Forskolin right through to XAV1938 and Y27632, which can be used to target a variety of signalling pathways, with numerous applications in regenerative medicine and cancer research.
More information online:
ilmt.co/PL/Z4oP Automation Options for Elemental Analysis
High-capacity automated sample loading is becoming an increasingly important factor to increase the efficiency of elemental analysis. Eltra offers various autoloaders for their combustion analysers, ranging from 32 to 130 crucible positions, allowing for unattended analyses overnight or even over the weekend.
For fast and robust O/N/H analysis in metals, the new autoloader for the ELEMENTRAC ONH-p 2 analyser features a sample carousel with 32 crucible positions, as well as a correspondingly designed crucible magazine. This combination currently represents the largest sample loader on the market for analysers with inert gas fusion and will be available end of this year. The ONH-p 2 analyser reliably measures oxygen, nitrogen and hydrogen concentrations in inorganic samples from low ppm content to high percentages.
More information online:
ilmt.co/PL/301k 58901pr@reply-direct.com New Vacuum Nucleation Induction Method for Lab Freeze-drying Processes
Lyonuc is a new nucleation induction method developed by Telstar that facilitates scaling up and optimisation from a laboratory pilot scale to industrial scale. It is a solution for effectively inducing the start of nucleation in the freeze-drying process that enables research centres and pharmaceutical laboratories to run freeze-drying process more efficiently, increasing the productively and improving the batch uniformly.
Particularly effective when testing and developing new recipes, Lyonuc is a standard option for LyoBeta, the range of twin-vessel pilot-scale freeze dryers designed by Telstar for research, development and scale-up of recipes for pharmaceutical freeze-drying processes.
The LyoBeta range is characterised by attributes of flexibility, high performance, and small footprint required in a laboratory unit, including advanced process control systems, management software and interface features.
This new nucleation induction method developed by Telstar reduces the duration of the primary drying cycle. The vacuum-induced nucleation produces a change in the solid structure of the solution and manages to homogenise the moment when the freezing starts so that all the vials nucleate at the same time in a few seconds, instead of taking 30-45 minutes which is how long the spontaneous nucleation process typically takes. This method based on controlling the temperature and pressure and inducing the start of the freezing phase, also ensures the uniformity and homogenisation of the vials in all the batches, respecting the product’s physiochemical properties.
The nucleation induction method can be adapted to any type and model of freeze-dryer. Unlike other methods where it is necessary to add gases external to the process or use decompression processes requiring special equipment, this new method only requires controlling the temperature, vacuum, and time. This new method is particularly focused on long duration freeze-drying cycles, where the benefit of reducing the drying time is much greater.
More information online:
ilmt.co/PL/M2wa 58937pr@reply-direct.com
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INTERNATIONAL LABMATE - FEBRUARY 2023
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