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Archive for category: Product News

Product News

biorad May 29

Bio-Rad introduces new antibodies for in vitro research, commercial applications

, 26 August 2020/in Product News /by 3wmedia

Bio-Rad Laboratories, a specialist in life science research and clinical diagnostic products, has extended its range of recombinant monoclonal anti-idiotypic antibodies with the introduction of antibodies that are specific for ipilimumab (Yervoy) and the ipilimumab/CTLA-4 drug-target complex. These highly specific and high-affinity antibodies are suitable for bioanalytical and patient drug level monitoring assays for the immune checkpoint inhibitor: ipilimumab.
Bio-Rad also announced the launch of a range of anti-certolizumab pegol inhibitory antibodies to support the development of assays for therapeutic drug monitoring of tumor necrosis factor (TNF) alpha inhibitors.
Ipilimumab activates the immune system by inhibiting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that hinders the destruction of cancerous cells, to treat cancers such as melanoma. The four anti-ipilimumab antibodies inhibit the binding of the drug to its target, CTLA-4, and therefore detect free drug. These antibodies are suitable for developing pharmacokinetic (PK) bridging ELISAs and being used as a surrogate positive control (or reference standard) for anti-drug antibody assays. The drug-target complex binder specifically recognizes the ipilimumab/CTLA-4 complex and can be used as the detection antibody in a PK antigen capture assay as an alternative format to the bridging ELISA.
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
The anti-ipilimumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
Anti-certolizumab pegol inhibitory antibodies
The range of recombinant monoclonal anti-idiotypic antibodies comprises three antibodies that are highly specific for the monoclonal antibody Fab fragment certolizumab pegol (Cimzia) and inhibit the binding of this drug to its target: TNF alpha. The antibodies are fully human in full length IgG format and can be used as a surrogate positive control or calibration standard for an ADA assay to measure levels of patient anti-drug antibodies.
TNF alpha inhibitors are used to treat a wide range of inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. The levels of serum drug and ADA concentrations are monitored in patients receiving TNF alpha antagonists to help guide clinical decision making, optimize treatment, improve outcomes, and reduce healthcare costs.
The anti-certolizumab pegol antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/biorad_May_29.png 378 416 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:34Bio-Rad introduces new antibodies for in vitro research, commercial applications
Beckman Coulter DX Access PCT reagent 563x480 web

Procalcitonin assay for Access immunoassay analysers

, 26 August 2020/in Product News /by 3wmedia

The Access PCT assay is the latest addition to the menu for the Access family of im-munoassay systems. The state-of-the-art sensitivity and low-end precision of Access PCT assay combined with short incubation time helps physicians in the risk assessment of critically ill patients in danger of progression to severe sepsis or septic shock, with test results available in under 20 minutes. Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or septic shock. The ability to rapidly diagnose suspected sepsis patients and determine appropriate care and treatment is critical, as earlier administration of antibiotics is highly correlated with increased patient survival. Access PCT enables healthcare providers to integrate procalcitonin testing analysis into their routine sepsis work-ups on core laboratory analysers, as a primary or reflex test programmed though Beckman Coulter’s REMISOL Advance middleware. Such integration simplifies laboratory workflow and optimizes institutional sepsis management protocols while reducing the operation expense of maintaining costly dedicated instrumentation. The Access PCT assay has received CE mark certification and is avail-
able for use on the Access family of immunoassay systems including the Access 2, UniCel DxI 600 and UniCel DxI 800.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Beckman_Coulter__DX_Access-PCT-reagent_563x480_web.jpg 480 563 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:44Procalcitonin assay for Access immunoassay analysers
C426 Haematex DOAC STOP product image

Direct oral anti-coagulant adsorbent

, 26 August 2020/in Product News /by 3wmedia

DOAC Stop eliminates all direct oral anti-coagulants (DOACs) from test plasmas, making it possible to obtain valid results for all conventional coagulation assays and tests for thrombophilia.  This adsorbent has amazing affinity for DOACs but no effect on clotting proteins, antibodies or heparins. Because it extracts only DOACs, a clotting test result which remains abnormal can be assumed to have other causes.  DOAC Stop minitabs (one/ml) disperse readily in plasma and take less than 5 minutes to bind more than 95% of DOACs in most cases. The adsorbent is quickly removable after it has done its work by centrifugation.  The minitabs work equally well on direct thrombin inhibitors (eg dabigatran) and those against FXa (rivaroxaban, apixaban, edoxaban) and have no effect on heparins or warfarin plasmas.  In most cases DOAC levels can be estimated quickly from the ratio of clotting test results before to after the extraction via an appropriate calibration curve. The best results are obtainable using high phospholipid dRVVT or APTT reagents.

HAEMATEX
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C426_Haematex_DOAC_STOP_product_image.jpg 529 424 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:52Direct oral anti-coagulant adsorbent
Pantelis Vlachos

Cytel announces East Alloy for easy access to verified Bayesian methods

, 26 August 2020/in Product News /by 3wmedia

Cytel Inc., an advanced analytics leader providing sophisticated quantitative insights to decision-makers in clinical investigation, has launched East Alloy. This new platform is a web-native extension of Cytel’s world-renowned East software for adaptive clinical trial design and analysis.
By leveraging the speed of cloud computing and the pace of SaaS delivery, East Alloy enables easy implementation of computationally intensive Bayesian methods that may be otherwise impractical. The launch of East Alloy builds on Cytel’s time-tested record of delivering cutting-edge Bayesian tools and engines to the pharmaceutical industry for optimized clinical trials.
Bayesian methods are of growing interest to the drug development industry, as they allow clinical investigators to leverage historical trial data as well as learnings from new data as it accrues throughout a trial. The result is better-informed decision making, greater program flexibility, and the ability to run smaller, more resource-efficient trials.
“Our longstanding dedication to adaptive Bayesian approaches means we’re perfectly placed to meet and exceed the growing innovation needs of the pharmaceutical sector,” said Pantelis Vlachos, Director and Strategic Consultant at Cytel. “But it’s key to ensure our customers can practically implement this kind of innovation. East Alloy, reinforced by industry-leading verification, training, and support from Cytel experts, means users can sustainably adopt Bayesian designs to expedite clinical development and overcome uncertainty without compromising scientific rigor.”
The release of East Alloy follows the launch of East Hosted in 2019, which brought Cytel’s East software into the cloud for the first time to simplify the deployment of software updates, reduce on-premise IT burden, and ultimately broaden access to Cytel’s trial design and analysis engines.

  • For more information about Cytel, visit: https://www.cytel.com

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Pantelis_Vlachos.png 772 696 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:28Cytel announces East Alloy for easy access to verified Bayesian methods
iMLayer

Revolutionary sample preparation for MS imaging

, 26 August 2020/in Product News /by 3wmedia

Shimadzu’s iMLayer boosts spatial resolution for MS imaging experiments. It enables reproducible matrix coating with small crystals and minimizes delocalization effects. Get a crystal clear view of microstructures in your sample.
Features

  • Creation of fine matrix crystals by unique matrix vapor deposition technology (sublimation) enabling high resolution MS imaging experiments
  • Minimized delocalization effects compared to conventional spraying method due to sublimation technique
  • Good reproducibility through automated matrix layer thickness control
  • Simple touch pad operation making the easy-to-use standalone instrument a sample preparation tool for any MS imaging experiment

For information please click here.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/iMLayer.jpg 737 958 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:37Revolutionary sample preparation for MS imaging
Bio Rad FCP CLI October

Quality indicator monitors instrument HIL interference detection

, 26 August 2020/in Product News /by 3wmedia

Although your instruments may automatically detect HIL interferences, shouldn’t the lab’s QC program include pre-analytical checks to monitor instruments’ ability to detect them? Studies show that interferences from hemolysed, icteric or lipemic (HIL) specimens are amongst the most common pre-analytical errors.  Liquichek Serum Indices is a quality indicator intended for use as part of laboratory interference testing to monitor an instrument’s ability to detect these three types of samples. Replicating relevant concentrations of HIL interferences using human-sourced materials will allow confidence in the instrument’s performance. With Bio-Rad’s Unity Interlaboratory Program, the user is able to compare instrument responses among peer groups to help avoid costly test repeats. https://tinyurl.com/yxpmoe2e
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Bio-Rad_FCP_CLI_October.jpg 387 542 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:46Quality indicator monitors instrument HIL interference detection
PRODUCT CLI ELITECHGROUP

ELITechGroup’s Staining Technology Expands with Aerospray® Cytology Slide Stainer/Cytocentrifuge

, 26 August 2020/in Product News /by 3wmedia

Logan, UT, January 17, 2020 – ELITechGroup Inc., recognized worldwide as slide staining and cytocentrifuge technologic pioneers and innovators, with nearly 30 patents, over the 35-year lifespan of Aerospray staining technology, announces the launch of the Aerospray Cytology Slide Stainer Cytocentrifuge. The ELITechGroup’s Aerospray Cytology Slide Stainer/Cytocentrifuge automates the preparation and staining of liquid based cytology specimens to facilitate the examination of an array of cell differentiations utilizing Papanicolaou staining techniques. The advantages of the Aerospray Cytology Slide Stainer/Cytocentrifuge is that the device performs two functions of sample preparation through cytocentrifugation and sample staining. The system maximizes cell recovery to the slide through the use of its Cytopro® Rotor, eliminates cross-contamination with an application of fresh stain for each slide, and provides programmable regressive and progressive staining capabilities that can be stored in memory to meet the needs and preferences of any end user. The instrument standardizes staining across multiple labs, provides consistently high-quality control, is low maintenance, reduces the labor/cost per slide, enables laboratory compliance, and is the perfect back-up for high automation laboratories for specialty staining and during maintenance. “ELITechGroup’s portfolio of Aerospray slide stainers and cytocentrifuges has enabled the company to develop a worldwide reputation for performance and reliability. Our new Aerospray Cytology Stainer/Cytocentrifuge proves our commitment to ongoing innovation by expanding into new laboratories where we can offer superior staining results,” says Bryce McEuen, Vice President, Biomedical Systems. ELITechGroup will be showcasing the Aerospray Cytology Slide Stainer/Cytocentrifuge at key industry events throughout the year of 2020. Learn more at AerosprayStaining.com.
About ELITechGroup
ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents for clinical systems, microbiology, molecular diagnostics, hematology, cytology, and sweat test systems. Their mission is to improve patient care by empowering laboratories to do more in less time, with accuracy, to enable rapid and accurate course of treatment for patients.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/PRODUCT_CLI_ELITECHGROUP.jpg 286 638 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:38ELITechGroup’s Staining Technology Expands with Aerospray® Cytology Slide Stainer/Cytocentrifuge

GE Healthcare Life Sciences releases software for cell therapy workflow

, 26 August 2020/in Product News /by 3wmedia

GE Healthcare Life Sciences continues to build out its flexible solutions across the cell therapy workflow with the commercial availability of SpinOculation C-Pro Protocol Software. Part of the Sepax™ C-Pro Cell Processing System, the software closes and automates the cell transduction step. When used in combination with the Sepax C-Pro instrument and CT-60.1 single-use kit, the software enables users to choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.
Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare Life Sciences, said: “Cell therapy manufacturing is complex and requires advanced technologies.
The SpinOculation C-Pro software application automates and simplifies a critical step in the cell therapy workflow and helps accelerate the development of next generation therapeutics.” Additionally, the SpinOculation C-Pro Protocol helps users:

  • Gain reproducibility in transduction steps with an automated and closed solution
  • Save time in the manufacturing process by reducing manipulations
  • Optimize transduction performance by adjusting open system parameters
  • Simplify process validation by not using transduction enhancers

The SpinOculation C-Pro application software is available worldwide.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 0 0 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:39GE Healthcare Life Sciences releases software for cell therapy workflow
CLI TRIMERO EPN on July 4 2019

C1q, C1 Inhibitor, C5 and Factor B assays for nephelometry and turbidimetry

, 26 August 2020/in Product News /by 3wmedia

TRIMERO offers C1q, C5, C1 (Esterase) Inhibitor and Factor B (C3 Proactivator) CE- marked assays for nephelometry and turbidimetry.
Assays are available for IMMAGE® immunochemical systems of Beckman Coulter and for BN™ Series nephelometers of Siemens Healthineers.
Turbidimetric assays and applications are also available for the most popular clinical chemistry analysers.
In order to ensure lot to lot traceability, values ​​have been referred to the International Ref. Preparation for human serum complement Factors (NIBSC code: W1032) of the WHO (World Health Organization). 
Other available assays for nephelometry and turbidimetry include:
KLoneus® Free Light Chains (FLC), Serum Amyloid A (SAA), IgD Immunoglobulins, Retinol Binding Protein (RBP) for serum and urine, Soluble Transferrin Receptor (sTfR), Hemopexin, Cystatin-C for serum and urine, A1-Microglobulin, B2-Microglobulin for serum and urine, Kappa and Lambda Light Chains for serum and urine.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/CLI_TRIMERO_EPN_on_July_4__2019.png 353 402 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:49C1q, C1 Inhibitor, C5 and Factor B assays for nephelometry and turbidimetry
horizon discovery

Horizon Discovery extends coverage of OncoSpan reference standards to FFPE and Liquid Biopsy

, 26 August 2020/in Product News /by 3wmedia

Horizon Discovery Group, a global leader in the application of gene editing and gene modulation for cell line engineering, has added two new sample formats to its cell-based OncoSpan reference standards for use in the development and validation of workflows for cancer diagnostic assays.
Horizon’s OncoSpan range now includes formalin-fixed, paraffin-embedded (FFPE) and cell-free DNA (cfDNA) formats for mimicking solid tumors and liquid biopsy samples, respectively, in addition to its well-established genomic DNA (gDNA) format. Its cfDNA format offers one of the largest number of variants and genes, over 380 and 152 respectively, of any characterized reference standard to help standardize liquid biopsy testing.
These cell-line derived reference standards closely mimic patient samples and offer an unlimited and reproducible resource to help ensure consistency during the establishment and validation of diagnostic assays. All three formats are delivered with batch-specific, next-generation sequencing (NGS) data, orthogonally validated by ddPCR, to allow researchers to further validate their analysis pipeline.
For further information, visit: horizondiscovery.com/en/products/diagnostic-reference-standards/PIFs/OncoSpan-cfDNA
Read more

https://clinlabint.com/wp-content/uploads/sites/2/2020/08/horizon_discovery-scaled.jpg 2560 2560 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:16:522021-01-08 11:20:34Horizon Discovery extends coverage of OncoSpan reference standards to FFPE and Liquid Biopsy
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Bio-Rad - Preparing for a Stress-free QC Audit

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