Beckman Coulter SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization

Beckman Coulter, a clinical diagnostics leader, today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells. The assay, which demonstrates 99.9% specificity and 98.3% sensitivity, is part of a suite of diagnostic solutions being developed by Beckman Coulter in response to the ongoing COVID-19 pandemic to guide physicians and patients in their healthcare decision making.


Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA

"Since March, the Beckman Coulter team has worked around the clock to develop a suite of assays that play a critical role in the ongoing global fight against COVID-19," said Julie Sawyer Montgomery , president of Beckman Coulter. "As a science-driven company, we continue in our commitment to deliver rigorously validated diagnostics of the highest quality that provide meaningful information, so doctors and patients alike can trust the results for urgent, care decisions."

Beckman Coulter's suite of COVID-19 testing solutions includes the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG assay, which received EUA in June. The company also recently received FDA Emergency Use Authorization for its interleukin 6 (IL-6) assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Beckman Coulter is also currently developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay anticipated to be launched later this year.

All of the Beckman Coulter assays to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as Beckman Coulter's Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

For more information on Beckman Coulter's suite of testing solutions or its commitment to the fight against COVID-19, visit: www.BeckmanCoulter.com/Coronavirus .

About the Access SARS-CoV-2 IgM Assay

The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilizes an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analyzers for smaller labs and healthcare clinics.

About Beckman Coulter

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif. , and has more than 11,000 global associates working diligently to make the world a healthier place.

© 2020 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

Beckman Coulter today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay detects antibodies that recognize the receptor-binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells.

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/beckman-coulter-sars-cov-2-igm-antibody-test-receives-fda-emergency-use-authorization-301149222.html

SOURCE Beckman Coulter Diagnostics

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Medtronic LABS Unveils Commitment To Scale Tech-Enabled Healthcare at Clinton Global Initiative 2023 Meeting

The commitment will form a consortium that brings together cross-sector partners to scale community-based, tech-enabled solutions for underserved patients, families, and communities across the world.

At Medtronic LABS, we're working every day to cultivate a bolder, more equitable, and outcomes-focused global health system for the future. This week, we announced a Commitment to Action to scale tech-enabled healthcare at the Clinton Global Initiative 2023 meeting

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT for the Treatment of Hypertension in Pacemaker Patients

  • Hypertension is the most common comorbidity in the pacemaker population, affecting over 70% of patients or approximately 750,000 people annually worldwide
  • Medtronic plc and Orchestra BioMed have an exclusive strategic collaboration for global development and commercialization of BackBeat Cardiac Neuromodulation Therapy™ (CNT), now also known as Atrioventricular Interval Modulation ("AVIM") therapy, for hypertensive pacemaker patients
  • BACKBEAT global pivotal study is expected to start before the end of 2023
  • IDE supported by data from the MODERATO II randomized pilot study that showed AVIM therapy drove significant and sustained reductions in blood pressure in hypertensive pacemaker patients
  • Orchestra BioMed management to host conference call today, September 19, 2023, at 8:30am ET

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration ("FDA") granted approval of an investigational device exemption ("IDE") to initiate the global pivotal BACKBEAT ( B radyc A rdia pa C ema K er with atrioventricular interval modulation for B lood pr E ssure tre A tmen T ) study evaluating the efficacy and safety of atrioventricular interval modulation ("AVIM") therapy (also known as BackBeat CNT™) for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health Announces CFO Transition Plan

Bausch Health Companies Inc. (NYSETSX:BHC) ("BHC" or the "Company") today announced that Tom Vadaketh, Executive Vice President, Chief Financial Officer, has resigned from his role to pursue another opportunity, and will be leaving the Company effective October 13, 2023. The Company thanks Mr. Vadaketh for his significant contributions and leadership during a period of transition at the Company

A formal search process to identify Mr. Vadaketh's permanent replacement has been initiated.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

BHC INVESTOR DEADLINE APPROACHING: Robbins Geller Rudman & Dowd LLP Announces that Bausch Health Companies Inc. Investors with Substantial Losses Have Opportunity to Lead Case

Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Bausch Health Companies Inc. (NYSE: BHC) securities between August 6, 2020 and May 3, 2023, all dates inclusive (the "Class Period") have until September 25, 2023 to seek appointment as lead plaintiff of the Bausch Health class action lawsuit. Captioned Kelk v. Bausch Health Companies Inc. No. 23-cv-03996 (D.N.J.), the Bausch Health class action lawsuit charges Bausch Health as well as certain of its top current and former executive officers with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the Bausch Health class action lawsuit, please provide your information here:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Final Deadline Approaching for Bausch Health Companies Inc. Investors: Kessler Topaz Meltzer & Check, LLP Reminds Bausch Health Companies Inc. Investors of September 25, 2023 Lead Plaintiff Deadline

The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that a securities class action lawsuit has been filed against Bausch Health Companies Inc. ("Bausch") ( NYSE: BHC ). The action charges Bausch with violations of the federal securities laws, including omissions and fraudulent misrepresentations relating to the company's business, operations, and prospects. As a result of Bausch's materially misleading statements and omissions to the public, Bausch's investors have suffered significant losses.

CLICK HERE TO SUBMIT YOUR BAUSCH LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/bausch-health-companies-inc?utm_source=PR&utm_medium=link&utm_campaign=bhc&mktm=r

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

New Bausch Health Treatment PrUCERIS Aerosol Foam Now Available Across Canada to Treat Mild to Moderate Distal Ulcerative Colitis in Adults

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is pleased to announce that following its approval by Health Canada the new treatment PrUCERIS® (budesonide) aerosol foam is now available across Canada to treat mild to moderate distal ulcerative colitis in adults

UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.[1] In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.[2]

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×