Beckman Coulter Offers $4/High-throughput Antigen Test to Support U.S. Government Initiative to Expand COVID-19 Testing

Beckman Coulter, a clinical diagnostics leader, today announced their commitment to support the U.S. government's plan to invest more than $12 billion to expand COVID-19 testing with their high-throughput, high-quality lab antigen test, Access SARS-CoV-2 Ag,* ideal for mass screening testing.


Beckman Coulter announced in December that their $4 antigen test will be available to all customers and has a confirmed 93% positive predictive agreement (PPA) and 100% negative predictive agreement (NPA). Results can be delivered in as little as 30 minutes on Beckman Coulter's immunoassay analyzers, including the DxI 800 high-throughput analyzer that can process up to 200 samples every 60 minutes.

"We support the U.S. government's goal to expand screening because this is the right way to open up our schools, our economy and get people back to work in tandem with the massive vaccination drive that is underway," said Julie Sawyer Montgomery , president of Beckman Coulter Diagnostics. "The key to saving lives while vaccines are being put into arms is still masking, social distancing, regular testing, tracing and isolation. Our antigen assay makes the regular testing part of this equation a reality by enabling institutions and communities to implement low-cost, frequent, mass COVID-19 testing with automation, ease of handling and speed to enable scalability."

Beckman Coulter's antigen test can be used for testing in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information, could identify those with a SARS-CoV-2 infection to minimize transmission i .

"We are offering our solution at $4 per test because it's only with affordable and regular testing that we can address disparities and promote equity in COVID-19 testing, which is vital to address COVID-19-related health gaps and advance health equity among high-risk and underserved populations, including racial and ethnic minority groups and people living in rural areas," said Shamiram R. Feinglass , M.D., MPH, chief medical officer for Beckman Coulter.

While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high-volume testing needs ii . Only Beckman Coulter's $4 SARS-CoV-2 antigen test makes large-scale, serial testing programs feasible and affordable.

"A point of care test that delivers a result in 15 minutes for a single individual cannot perform as efficiently when it's asked to deliver results for hundreds or thousands of people; the workflow breaks down with too many manual handling steps in the process," said Dr. Feinglass. "Furthermore, a hospital is compelled to report positive results to the regulatory bodies, and some point of care tests require cumbersome manual recording of patient data into their EMR."

Ideal for implementing as part of a large-scale community, workplace or school screening program, Access SARS CoV-2 Antigen test samples are collected with a nasopharyngeal or nasal swab and can be stored at room temperature for up to 24 hours and 48 hours refrigerated (2-8 degrees Celsius) with one freeze/thaw cycle.

The assay also provides ultimate flexibility in scaling to address the needs of small or low volume to moderately-sized laboratories that operate a desktop analyzer, to large laboratories with automated, high-throughput analyzers for mass testing. Whether on a desktop with an Access 2 or on a high-throughput analyzer like the DxI 800, results are immediately delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment quickly, isolate patients, and start tracing, helping to minimize the spread of COVID-19.

Learn more about Beckman Coulter's affordable, reliable and designed for high-throughput antigen solution at wwwbeckmancoulter.com/accessantigen .

Beckman Coulter's Suite of COVID-19 Testing Solutions

Beckman Coulter offers a menu that matters for COVID-19, including the $4 Access SAR-CoV-2 Antigen assay, as well as three antibody assays: Access SARS-CoV-2 IgM, Access SARS CoV-2 IgG and the semi-quantitative SARS-CoV-2 IgG II. Beckman Coulter is also developing a SARS-CoV-2 quantitative IgG assay based on WHO reference ranges.

The company also has an interleukin 6 † (IL-6) assay, which can be used to aid physicians in identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients. Beckman Coulter also offers a biomarker that measures monocyte distribution width (MDW), which can be used as an aid in the early detection of sepsis in adult patients presenting to the emergency department. Earlier this year, the company received government funding to develop a machine learning algorithm to help accurately predict and detect sepsis in COVID-19 patients leveraging its MDW test. Additionally, in mid-October, Beckman Coulter was awarded funding by for a multi-center clinical trial to validate the ability of MDW to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe COVID-19 complication.

All of Beckman Coulter's assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter's Access 2 analyzer, a compact, tabletop 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.

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.

i https://www.reuters.com/article/health-coronavirus-rapid-tests/countries-turn-to-rapid-antigen-tests-to-contain-second-wave-of-covid-idUSL8N2H44VF [Accessed: October 19, 2020 ]
ii
https://www.the-scientist.com/news-opinion/the-push-to-deploy-at-home-antigen-tests-for-covid-19-67831 [Accessed: October 12, 2020 ]

*This test has not been reviewed by the FDA. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.

† For Use Under the Emergency Use Authorization (EUA) Only. For In Vitro Diagnostic Use. Access IL-6 is available in the U.S. under the FDA Emergency Use Authorization program as an aid in identifying COVID-19 patients at risk of intubation with mechanical ventilation.

© 2021 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. 2021-8839

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/beckman-coulter-offers-4high-throughput-antigen-test-to-support-us-government-initiative-to-expand-covid-19-testing-301250488.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 Therapyâ„¢ (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

×