Thermo Fisher Scientific has established new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of innovative solutions for unmet needs in clinical biomarker discovery. The new alliances strengthen the PMSC’s mission of creating standardized workflows with pharma and academic partners to streamline the transition from biomarker research to clinical implementation, creating new opportunities for precision medicine.
Ongoing and planned studies with both AstraZeneca and the University of Nebraska Medical Center will utilize standardized plasma protein profiling workflows, including Thermo Fisher’s newly developed ultra-high throughput plasma protein profiling (uHTPPP) workflow, for biomarker discovery, for a range of conditions. The standardized workflows consist of automated sample preparation for untargeted and targeted methods in combination with the Thermo Scientific Orbitrap Exploris 480 and Thermo Scientific Orbitrap Exploris 240 mass spectrometers.
“Precision medicine is becoming a greater area of interest across a range of different diseases and has, therefore, faced challenges effectively scaling to meet clinical needs,” said Emily Chen, senior director, PMSC. “The goal of the Precision Medicine Science Center is to construct end-to-end workflow solutions that generate impactful data from discovery studies with large human cohorts and to harness the power of molecular profiling to improve the outcomes of patient care. Our ongoing work with AstraZeneca and the University of Nebraska Medical Center are paramount to realizing the potential of these technologies.”
Ventzi Hristova, senior scientist, dynamic omics, antibody discovery and protein engineering, R&D at AstraZeneca, said: “Powered by technological innovation, omics is proving to be one of the richest sources of data in all of science. Clinical proteomics is an emerging field aimed at improving patient care through the development of sensitive, high-throughput methods for in-depth proteomic characterization of clinical samples. This collaboration aims to evaluate and establish a model for clinical proteomics, using advanced sample processing and downstream analytical applications, that has the potential to help us identify new drug targets and biomarkers.”
DiaSys introduces Procal-citonin FS fluid-stable, particle-enhanced immunoturbidimetric assay
, /in Product News /by 3wmediaDiaSys has launched a fluid-stable, particleenhanced immunoturbidimetric assay for determination of procalcitonin (PCT) in serum and plasma on clinical chemistry analysers.
Procalcitonin FS offers high precision at clinical cut-off levels for sepsis with a measuring range from 0.2 ng/mL to 50 ng/mL. Procalcitonin FS has an outstanding onboard and calibration stability. No prozone effect was observed up to 1000 ng/mL.
The assay performance is complemented by high tolerance to endogenous interferents and common therapeutics used in sepsis management. Method comparisons of Procalcitonin FS show good comparability to established tests and present the new assay as a reliable alternative for clinical chemistry analysers.
For more information, visit: www.diasys-diagnostics.com/products/reagents/ immunoturbidimetry/reagent-details/227- procalcitonin-fs/reagent.show
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BD granted FDA clearance for BD FACSLyric Flow Cytometer with newly integrated BD FACSDuet Sample Preparation System
, /in Product News /by 3wmediaBD (Becton, Dickinson and Company), a leading global medical technology company, has received 510(k) clearance from the U.S. FDA for the BD FACSLyric™ Flow Cytometer with the Integrated BD FACSDuet™ Sample Preparation System.
The new integrated system enables clinical laboratories to fully automate the sample to answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the BD FACSLyric™ Flow Cytometer.
The BD FACSDuet Sample Preparation System builds new capabilities into the BD portfolio of clinical flow cytometry solutions offering a pre-analytical system, that combined with the BD FACSLyric Flow Cytometer is the first truly walkaway sample-to-answer solution for clinical labs.
Physical integration between the BD FACSDuet Sample Preparation System and the BD FACSLyric Flow Cytometer allows technicians to load samples and reagents’ samples are acquired and analysed on the BD FACSLyric Flow Cytometer. Data integration using the BD FACSLink™ Middleware Solution offers bidirectional communication between the instruments and connectivity with laboratory information systems.
The BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System is now available as an in vitro diagnostic (IVD) system in the United States as well as countries recognizing the CE-IVD certification, which was achieved in March 2019.
For more information, visit: www.bdbiosciences.com/en-us/instruments/ clinical-instruments/clinical-cell-analyzers/facslyric
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Bio-Rad introduces StarBright Violet 515 Dye for flow cytometry
, /in Product News /by 3wmediaBio-Rad Laboratories, a global leader of life science research and clinical diagnostic products, has introduced StarBright Violet 515 (SBV515) Dye, the first of a new range of unique fluorescent nanoparticles, for use in flow cytometry. Star- Bright Dyes are conjugated to a growing range of antibodies and are compatible with most flow cytometers and experimental protocols.
The StarBright Violet 515 Dye with an excitation maximum at 401 nanometre and emission maximum of 516 nanometre offers researchers improved brightness to resolve rare and low antigen density populations more easily. It has a narrow emission profile to reduce spillover into neighbouring filters and minimal excitation by other lasers, making it suitable for inclusion in multicolour panels.
The dye is not susceptible to photobleaching, delivers high lot-to-lot reproducibility, and is stable at 4°C with no loss of signal to help ensure consistent staining and deliver reliable results. It has been tested in many common staining buffers and there is no requirement to use a special staining buffer, permitting easy integration into common experimental protocols without compromising performance. StarBright Violet 515 Dye is compatible with Bio-Rad’s ZE5 Cell Analyzer, S3e Cell Sorter, as well as other cytometers, and it is suitable for both conventional and spectral flow.
Mike Blundell, Bio-Rad Product Manager, Life Science Group, commented: “StarBright Violet 515 Dye is brighter than other common dyes that emit at similar wavelengths. The dye is flexible enough to fit into any flow cytometry panel, allowing researchers to multiplex with ease regardless of flow cytometer and experimental protocol, and it offers a superior alternative for fluorophores that have emission maxima between 500 and 550 nanometres.”
For more information, visit: www.bio-rad-antibodies.com/starbright
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Promega introduces Spectrum Compact CE benchtop DNA analysis instrument with Hitachi High-Tech
, /in Product News /by 3wmediaPromega has launched its benchtop capillary electrophoresis (CE) instrument, the Spectrum Compact CE System, developed in collaboration with Hitachi High-Tech. The personal CE system is an integrated DNA analysis instrument that enables life scientists in laboratories of all sizes to perform Sanger sequencing and fragment analysis at the bench.
The Spectrum Compact CE System features:
The instrument supports applications such as microsatellite instability analysis, mixed sample analysis, forensic STR analysis, and cell line authentication. It processes up to 32 samples in a single run and can be controlled by either the integrated touchscreen or by additional software that allows access from any registered computer on the same network. Guided software brings capillary electrophoresis capabilities to the hands of any scientist in the laboratory regardless of skill level.
“The Spectrum Compact CE is personal and that’s one of the huge advantages that scientists will see with this instrument,” commented Doug Storts, Promega Head of Research. “An individual can walk into the laboratory and with minimal training, be able to change all the consumables, select which chemistries they want to use for both DNA sequencing as well as for fragment analysis, and perform the experiment.”
Promega is also offering extensive support to laboratories integrating a Spectrum Compact CE System into their workflow, including on-site instrument and software installation and operational training. Technical Services Scientists are prepared to assist with data analysis and summary reports, and Field Support and Validation Services Scientists are available to assist with maintenance and validation requirements.
For more information, visit: www.promega.com/SpectrumCompactCE
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Automated immunofluorescence microscopy incorporating artificial intelligence
, /in Product News /by 3wmediaThe new EUROPattern Microscope Live from Euroimmun provides state-of-the-art on-screen immunofluorescence microscopy with automated evaluation of results using AI processes. The immunofluorescence images are acquired rapidly in less than two seconds per image using novel automatic laser focusing.
The compact microscope includes an integrated controlled LED and fluorescence standard for constant illumination, ensuring standardised quality for microscopes at different locations. The images are recorded by means of a highresolution camera. The captured images are classified as positive, negative or borderline by means of deep-learning processes using deep convolutional neural networks. The system also incorporates pattern recognition for anti-nuclear antibodies (ICAP compliant).
Immunofluorescence evaluation applications are also available. DataMatrix codes on the slides ensure reliable assignment of the samples to their corresponding results. The middleware EUROLabOffice 4.0 provides state-of-the-art digital laboratory organisation with intelligent interconnection of different workstations and different locations. The software communicates continuously with the LIS and laboratory instruments, ensuring reliable, traceable and rapid data exchange.
Predefinable workflows and automatically generated protocols enable efficient organi -sation of the daily workload. Results from different workstations are consolidated for each patient and presented with the patient history and all fluorescence images. Patient data, customer details and article information are all administered and archived by the system. The software is simple and intuitive to operate, with no unnecessary manual steps, thus saving time and reducing workload for laboratory staff. The clear user interface makes it ideal for all workplaces, including the laboratory microscopy room and office.
For more information, visit: www.euroimmun.com
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DiaSys Diagnostic Systems launches respons940 – a clinical chemistry analyser for medium-sized labs
, /in Product News /by 3wmediaDiaSys Diagnostic Systems has launched respons940 to complement the respons system family. This clinical chemistry analyser has a true throughput of 640 test/h including ISE measurements. With durable hard glass cuvettes, low reaction volumes, maintenance free photometer and intuitively operated software, respons940 offers the economic use required in medium sized laboratories.
Dedicated respons system reagent kits including CE marked applications and carry over evasion lists ensure highest result security combined with the ease of use of the respons analysers.
For more information, visit: www.diasys-diagnostics.com/products/instruments/responsr940/
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Serum Amyloid A (SAA) nephelometric assay, for IMMAGE® Immunochemical Systems
, /in Product News /by 3wmediaTRIMERO Diagnostics offers an IVD CE marked assay for testing Serum Amyloid A (SAA) on Beckman Coulter’s IMMAGE® Immunochemical Systems.
Main features of the assay are:
SAA turbidimetric assays are also available for the most popular clinical chemistry analysers.
Other available assays for IMMAGE® nephelometers and turbidimetry include: KLoneus® Free Light Chains (FLC) for serum and urine, Beta-2 Microglobulin for serum and urine, IgD Immunoglobulins, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, A1-Microglobulin, Kappa and Lambda Light Chains for serum and urine, Complement C1q, Complement C5, Factor B (C3 Proactivator), C1 (Esterase) Inhibitor.
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Bio-Rad now offers the Platelia SARS-CoV-2 Total Ab assay
, /in Product News /by 3wmediaAs COVID-19 continues to impact countries worldwide, accurate screening is needed to establish serological status of different populations. Bio-Rad now offers the Platelia SARS-CoV-2 Total Ab assay, for the detection of total anti-nucleocapsid antibodies (IgM, IgA, IgG) to SARS-CoV-2. In one test, the assay helps identify the immune response to coronavirus SARS-CoV-2, the virus associated with COVID-19.
For more information, visit: https://info.bio-rad.com/cdg-sars-cov-2-ous?WT.mc_id=201012029377
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Roche acquires Enterprise Therapeutics’ First-in-Class TMEM16A potentiator program for treatment of cystic fibrosis
, /in E-News /by 3wmediaRoche has acquired Enterprise Therapeutics novel TMEM16A potentiator portfolio, which will be developed by Genentech, a member of the Roche Group. The portfolio includes ETD002 which recently entered Phase 1 trials.
Enterprise’s shareholders received an upfront payment of £75 million and are eligible to receive additional contingent payments, to be made based on the achievement of certain predetermined milestones.
The TMEM16A portfolio is focused toward treating all people with cystic fibrosis, with potential to benefit people with other severe respiratory diseases characterised by excessive mucus congestion.
Dr John Ford, CEO, Enterprise Therapeutics, said: “Roche and Genentech have a proven track record of bringing new medicines to people with respiratory diseases, and have recognised the opportunity that our TMEM16A potentiator portfolio presents. I am very proud of the team at Enterprise for identifying and developing this innovative approach to treat patients, with ETD002 the first of our compounds to reach clinical stage. TMEM16A potentiation has the potential to significantly increase the quality of life for people living with cystic fibrosis, for many of whom existing therapies are not effective.”
Dr James Sabry, MD, PhD, Global Head of Pharma Partnering, Roche, commented: “We are excited to add Enterprise’s TMEM16A potentiator program to our existing respiratory portfolio. We have deep capabilities in this area and look forward to a robust program focused on helping cystic fibrosis patients and patients suffering from other muco-obstructive disorders as quickly as possible.”
Thermo Fisher Scientific collaborates with AstraZeneca and University of Nebraska Medical Center for biomarker discovery
, /in E-News /by 3wmediaThermo Fisher Scientific has established new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of innovative solutions for unmet needs in clinical biomarker discovery. The new alliances strengthen the PMSC’s mission of creating standardized workflows with pharma and academic partners to streamline the transition from biomarker research to clinical implementation, creating new opportunities for precision medicine.
Ongoing and planned studies with both AstraZeneca and the University of Nebraska Medical Center will utilize standardized plasma protein profiling workflows, including Thermo Fisher’s newly developed ultra-high throughput plasma protein profiling (uHTPPP) workflow, for biomarker discovery, for a range of conditions. The standardized workflows consist of automated sample preparation for untargeted and targeted methods in combination with the Thermo Scientific Orbitrap Exploris 480 and Thermo Scientific Orbitrap Exploris 240 mass spectrometers.
“Precision medicine is becoming a greater area of interest across a range of different diseases and has, therefore, faced challenges effectively scaling to meet clinical needs,” said Emily Chen, senior director, PMSC. “The goal of the Precision Medicine Science Center is to construct end-to-end workflow solutions that generate impactful data from discovery studies with large human cohorts and to harness the power of molecular profiling to improve the outcomes of patient care. Our ongoing work with AstraZeneca and the University of Nebraska Medical Center are paramount to realizing the potential of these technologies.”
Ventzi Hristova, senior scientist, dynamic omics, antibody discovery and protein engineering, R&D at AstraZeneca, said: “Powered by technological innovation, omics is proving to be one of the richest sources of data in all of science. Clinical proteomics is an emerging field aimed at improving patient care through the development of sensitive, high-throughput methods for in-depth proteomic characterization of clinical samples. This collaboration aims to evaluate and establish a model for clinical proteomics, using advanced sample processing and downstream analytical applications, that has the potential to help us identify new drug targets and biomarkers.”