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Tag Archives: Beckman Coulter

Beckman launches quantitative COVID-19 IgG test

July 2021—Beckman Coulter launched its Access SARS-CoV-2 IgG (1st IS), a fully quantitative lab-based immunoglobulin G serology test that measures the quantity of antibodies against the virus that causes COVID-19. The assay is traceable to the First WHO International Standard for anti-SARS-CoV-2, 20/136, and reports results aligned with BAU/mL established by the World Health Organization.

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FDA authorizes Beckman’s IgG antibody for SARS-CoV-2

June 2021—Beckman Coulter’s Access SARS-CoV-2 IgG II antibody assay received emergency use authorization from the FDA. The semiquantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units. It measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus.

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Beckman SARS-CoV-2 IgM antibody test

October 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay. The IgM antibody test demonstrated 99.9 percent specificity against 1,400 negative samples, the company reports, and 98.3 percent sensitivity at 15 to 30 days post-symptom onset. The test measures antibodies to the receptor binding domain of the spike protein, which the SARS-CoV-2 virus uses to bind to a human cell receptor.

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Access SARS-CoV-2 IgG assay gets EUA

August 2020—Beckman Coulter has received FDA emergency use authorization for its Access SARS-CoV-2 IgG assay, a qualitative immunoassay that detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient blood or serum samples. The test has a confirmed 100 percent positive percent agreement and 99.6 percent negative percent agreement.

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Access PCT cleared by FDA

March 2020—Beckman Coulter’s Access PCT assay has received FDA 510(k) clearance and is available for sale in the United States. The assay enables health care providers to integrate procalcitonin testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary or reflex test programmed through Beckman Coulter’s Remisol Advance middleware. Test results are available in less than 20 minutes.

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Beckman DxA 5000 gets CE mark

July 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has achieved the CE mark and China Food and Drug Administration approval. The DxA 5000 aims to deliver rapid and consistent turnaround time, provide a new level of comprehensive preanalytical sample quality detection, and reduce the number of manual processing steps.

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DxA 5000 total lab automation solution CE marked

May 9, 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has achieved the CE mark and China Food and Drug Administration approval. The DxA 5000 aims to deliver rapid and consistent turnaround time, provide a new level of comprehensive preanalytical sample quality detection, and reduce the number of manual processing steps.

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Beckman Coulter’s Early Sepsis Indicator gets 510(k) clearance

April 22, 2019—Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. The Early Sepsis Indicator is a hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or who are at an increased risk of developing sepsis and is reported automatically as part of a routine CBC with differential test.

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Newsbytes

February 2019—Digital pathology RFPs: from the questions to selections: To those who request the information and those who supply the information, requests for proposal, better known as RFPs, can be groanworthy. Yet laboratories planning to purchase a digital pathology system for clinical use should seriously consider going through the painstaking process, even if their institutions don’t require it, says Liron Pantanowitz, MD, vice chair of pathology informatics at the University of Pittsburgh Medical Center.

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Newsbytes

January 2019—Virtual tumor board platforms: a game changer for cancer case review: If Suneal Jannapurredy, MD, had been able to read the patient’s outside radiology report prior to breast tumor board, he would have re-examined the gross specimen to determine whether, as the other providers were now telling him, there was a second area of focus he hadn’t included in his presentation.

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Beckman Coulter releases cloud-based middleware solution

Dec. 21, 2018—Beckman Coulter announced the U.S. release of its DxOne Workflow Manager, cloud-based middleware that aims to help low-volume laboratories standardize workflows, automate processes, and consolidate information. Technologists can manage samples by exception using autoverification and can get an at-a-glance view of ordering information and patient demographics on one screen. Comments and flags are readily visible, alerting users to ...

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Beckman Coulter rolls out DxOne Inventory Manager

Dec. 3, 2018—Beckman Coulter announced the commercial availability of the DxOne Inventory Manager, its automated, cloud-based software technology that aims to simplify inventory management and enhance operational efficiencies to help ensure timely delivery of patient test results. “For many laboratories, managing supplies involves repetitive, time-consuming, and often manual tasks. DxOne Inventory Manager eliminates the administrative aspects of supply management by ...

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Beckman releases DxM MicroScan

September 2018—Beckman Coulter announced commercialization of its DxM MicroScan WalkAway system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing that uses direct minimum inhibitory concentrations for detection of antimicrobial resistance.

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Beckman releases new version of middleware

Sept. 12, 2018–Beckman Coulter launched version 1.10 of its Remisol Advance middleware system for mid- to high-volume laboratories. Enhancements include a centralized dashboard that combines sample status information (pending, stat, validated, and processed), turnaround time data, and quality control alerts in an intuitive format. “By providing a snapshot display of important analytics in a single location, we are enabling technologists ...

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Beckman releases DxM MicroScan

Aug. 7, 2018—Beckman Coulter announced commercialization of its DxM MicroScan WalkAway system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing that uses direct minimum inhibitory concentrations for detection of antimicrobial resistance. The system’s delivery of gold-standard MIC accuracy helps laboratories achieve their operational goals by reducing costs associated with confirmatory testing, the company says. Added workflow enhancements include ...

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Beckman Coulter, Arkray launch iQ Workcell

Aug. 1, 2018—Beckman Coulter and U.S. Arkray announced a partnership and the launch of the iQ Urinalysis Workcell, which pairs Beckman’s Iris iQ200 Digital Flow Morphology system with the Arkray Aution Max AX-4030 fully automated urine analyzer. The iQ Urinalysis Workcell will be available in the U.S. exclusively through Beckman Coulter; the company will also offer the Aution Max AX-4030 ...

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Beckman’s Early Sepsis Indicator gets CE mark

July 2018—Beckman Coulter announced its Early Sepsis Indicator received the CE mark. The Early Sepsis Indicator is a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis and is to be offered as part of a routine CBC with differential test.

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Beckman Coulter, Augusta University Medical Center alliance, 10/16

October 2016—Beckman Coulter, an operating company of Danaher, and Augusta University (Ga.) Medical Center signed a 15-year master service agreement. The alliance aims to create innovative models of care using technology and process improvement methodologies in the laboratory setting, ultimately providing enhanced patient care and significant long-term cost savings for the medical center.

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Analytical and workflow systems, 9/15

Beckman Coulter Diagnostics’ boothBeckman Coulter Diagnostics’ booth showcased its portfolio of high-productivity analytical and workflow systems. Solutions featured in the booth included the Power Express automation solution, the new DxH Connected Workcell, and IRIS International urinalysis solutions for automated urinalysis.

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Troponin test spots MIs earlier, 7/15

July 2015—Beckman Coulter Diagnostics announced the publication of research results in Clinical Biochemistry (Storrow AB, et al. 2015;48:254–259; 260–267) that identify the precise magnitude of change in cardiac troponin required for early diagnosis of a heart attack using its Access AccuTnI+3 troponin I blood test. Beckman’s troponin-I assay has been clinically proven through a large, multicenter study and is FDA-cleared and directly aligned with the FDA’s October 2010 guidance to manufacturers of troponin tests.

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FDA-cleared flow cytometer, 6/15

June 2015—Beckman Coulter’s automated Aquios CL Flow Cytometer has received FDA clearance for use in the clinical laboratory. With its small footprint and high precision, the “load and go” instrument has been designed for the Lean laboratory. With integrated automated sample preparation, Aquios CL Flow Cytometer delivers first results within 20 minutes for routine applications such as immunophenotyping.

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Scalable RNA sequencing service line, 4/15

April 2015—Beckman Coulter Genomics has added stranded, ribodepletion and globin reduction library construction options to its existing RNA-Seq services. The Illumina TruSeq Stranded Total RNA Sample Prep Kit has been validated at Beckman Coulter Genomics for human, mouse, rat, and plant samples and automated on Beckman Coulter instruments to enable scalability and LIMS sample tracking. In addition, it includes the ability to work with samples derived from blood and formalin-fixed, paraffin-embedded tissue.

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FDA clearance for vitamin D assay, 2/15

Beckman Coulter Diagnostics has received FDA 510(k) clearance for the Access 25(OH) Vitamin D Total assay. The assay is available for use on the company’s Access 2 and UniCel DxI series of immunoassay systems and provides excellent stability and convenient storage through packaging designed to prevent light-induced reagent degradation.

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Beckman Coulter Genomics integrates Clarity LIMS

January 2015—Beckman Coulter Genomics has integrated a Genologics Clarity LIMS into its Illumina HiSeq-based next-generation sequencing workflows. RNA sequencing, target capture, whole-genome sequencing, and pre-made library samples are tracked by the laboratory information management system from acquisition through quality control, library prep, and Illumina sequencing. Sample handling is provided for all workflows and chain-of-custody information is preserved.

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Expanded platforms for hemoglobin A1c test

January 2015—Beckman Coulter Diagnostics has launched its next-generation Hemoglobin A1c assay with improved performance across its chemistry systems. The assay has been standardized for use on all platforms of the company’s AU clinical chemistry systems for off-line sample preparation use and for online sample preparation use on the company’s UniCel DxC systems and is FDA 510(k) cleared for both analyzers.

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Laboratory solutions, 9/14

September 2014—Beckman Coulter Diagnostics showcased five laboratory solutions in its booth, which was themed “New Laboratory Challenges Require New Thinking”: the Power Express automation solution consolidates immunoassay, hematology, and coagulation; the DxH Connected Workcell offers labs workflow management while delivering comprehensive and accurate patient results; the latest addition of the IRIS International urinalysis portfolio; the Remisol Advance enterprise data management system; and its immunoassay diagnostic testing menu, which includes AccuTnI+3 troponin I in the cardiac panel, the Prostate Health Index (phi) as part of the men’s health panel, and a complete reproductive panel.

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Software package for data acquisition in cytometry, 7/14

July 2014—Kaluza for Gallios software for the Beckman Coulter Gallios cytometer uses data acquisition tools to increase efficiency and performance in the cell characterization and analysis workflow of core research laboratories. The software features a guided, intuitive drag-and-drop interface and facilitates creation of the right setup for accurate plot output. Visual management tools enable tracking of instrument function and experiment progress. Voltage and compensation can be quickly changed, and unlimited “undo” aids new users.

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Beckman Coulter to acquire Xitogen, 6/14

June 2014—Beckman Coulter entered into an agreement to acquire Xitogen Technologies together with Cytojene Corp. Xitogen, a flow cytometer developer based in Suzhou and Dalian, China, will provide Beckman Coulter Life Sciences with an operational base in the China market, and the facilities in Suzhou and Dalian will function as research and development and manufacturing centers.

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High-performance centrifuge, 6/14

June 2014—Avanti JXN-26 centrifuges from Beckman Coulter have an intuitive interface and advanced data management features, including the ability to track and manage centrifuge runs remotely using Mobile­Fuge, a mobile application for Apple iOS or Android devices.

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Coulter Counter, 5/14

May 2014—The Multisizer 4e Coulter Counter from Beckman Coulter Life Sciences has a 10-µm aperture for obtaining accurate count, size, and mass distribution for particles and cells ranging from 0.2 to 1,600 µm. Digital pulse processing provides high-resolution analysis in up to 400 channels.

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Benchtop centrifuges, 11/13

The Allegra X-5 air-cooled benchtop centrifuge from Beckman Coulter Life Sciences is designed specifically for clinical sample preparation. Bundled packages, which include swinging bucket rotors and common adapters, enable fast and convenient setup and are offered for a range of clinical sample prep applications.

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Beckman expands flow cytometry line, 9/13

Beckman Coulter Life Sciences has acquired the flow cytometry business assets of ReaMetrix India, a Bangalore-based life science technology company. The transaction provides Beckman Coulter with temperature-stable, single-dose, multi-color antibody cocktails targeting the HIV monitoring and clinical research markets.

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Automated ESR analysis system, 9/13:78 (AACC)

Through a distribution agreement with Alifax, Beckman Coulter and Iris Diagnostics have launched the Alifax automated erythrocyte sedimentation rate (ESR) analysis system. The automated ESR analysis systems are designed to fit the workloads of small hospitals, large reference laboratories, core laboratories, and satellite locations. The ESR system increases productivity, improves efficiencies in laboratory labor use, and reduces turnaround times. The ...

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HbA1c test, 9/13 (AACC)

Beckman Coulter’s FDA-approved hemoglobin A1c assay (HbA1c) with improved performance is for standard use on the company’s UniCel DxC systems. The HbA1c reagent was designed and developed to improve accuracy and precision, to continue to meet the latest accuracy grading from the College of American Pathologists and the recommendations of the National Glycohemoglobin Standardization Program and International Federation of Clinical ...

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Troponin I assay, 9/13:76 (AACC)

Beckman Coulter’s FDA-cleared Access AccuTnI+3 troponin I assay is available for use on the company’s Access 2 immunoassay system. In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects. The trial confirmed that the assay provides the clinical performance necessary for optimal patient management. ...

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Hematology analyzer, 9/13:76 (AACC)

Beckman Coulter’s UniCel DxH 600 Coulter cellular analysis system is for mid- to high-volume laboratories. The benchtop hematology analyzer—with advanced software—provides laboratories with exceptional quality results, improved first-pass accuracy, and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes. The UniCel DxH 600 is equipped with software that saves time by allowing labs to partially release ...

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Data processing and storage system, 9/13:74 (AACC)

Beckman Coulter’s Remisol Advance data-management system, v1.7 streamlines laboratory workflow and the result management process by improving sample tracking and results archiving, and through consolidating patient test information from multiple instruments in the lab or from multiple labs in the hospital network. Remisol Advance v1.7 unifies data management and features a 166 percent increase in sample data processing throughput and ...

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PerFix reagent kits, 9/13

Beckman Coulter Life Sciences’ new reagent kits for intracellular staining minimize sample manipulation for a streamlined workflow. Developed for use on Beckman Coulter’s Gallios and Navios series flow cytometers and compatible with all Beckman fluorochromes, the kits enable a clear focus on the cytoplasmic and nuclear compartments of the cell.

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Microcentrifuges, 8/13:88

Beckman Coulter’s Microfuge 20 and 20R microcentrifuges are designed to meet the specific requirements of a range of research applications and are easy to use. Paired with Microfuge series rotors, the microcentrifuges provide flexibility and reliable, precise performance while occupying a small footprint.

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Expansion of state licensure for BRAF assay, 7/13

Beckman Coulter Genomics’ BRAF assay has been granted clinical laboratory licenses in Pennsylvania, Maryland, Rhode Island, and Massachusetts. CLIA certification, plus licensure in those states, allows Beckman to accept clinical samples for genetic sequencing—the most technically complex CLIA category—and provide those results to physicians to use in treating, diagnosing, and preventing disease in patients.

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Troponin I assay, 7/13:104

Beckman Coulter has received FDA 510(k) clearance for its Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects, and confirmed that the assay provides the clinical performance necessary for optimal ...

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Hematology analyzer, 6/13:96

Beckman Coulter’s UniCel DxH 600 Coulter cellular analysis system is a benchtop hematology analyzer for mid- to high-volume laboratories. The system provides laboratories with exceptional quality results, improved first-pass accuracy, and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes.

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Beckman, CellaVision enhance partnership, 5/13:85

CellaVision and Beckman Coulter have added Europe, the Middle East, and Africa to their global distribution agreement. The agreement gives Beckman Coulter a nonexclusive right to sell CellaVision’s products in hematology laboratories worldwide, except in Canada and Japan. Beckman and CellaVision have been developing their partnership since 2010, when they partnered in the United States, Latin America, and Asia-Pacific, including in China and India.

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