Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

Below is the updated press release.

Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

The Access SARS-CoV-2 Antigen assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable

Assay's limit of detection is 2 to 200 times lower therefore more sensitive than most point-of-care (POC) antigen tests

Test runs on Beckman Coulter's analyzers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes and addressing the scalability constraints of POC tests

Company is submitting for EUA and can ship up to 25 million tests per month

BREA, Calif., Dec. 18, 2020 /PRNewswire/ -- Beckman Coulter, a leader in clinical diagnostics, today announced the launch of a new test that addresses the three main barriers currently facing schools, businesses, hospitals and communities with the rollout of mass COVID-19 testing. The new Access SARS-CoV-2 Antigen assay is one of the first cost-effective high-quality, high-throughput COVID-19 test available in the U.S. with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.

The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement (PPA) within seven days post symptom onset and 100% Negative Percent Agreement (NPA). Additionally, the assay and has a limit of detection of 33 TCID50/mL, which is 2 to 200 times lower and therefore more sensitive than the reported limits of detection for most of the available point-of-care (POC) antigen tests¹. Results of the Beckman Coulter antigen test can be delivered in as little as 30 minutes on the organizations' immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.

According to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives². New York University economist Paul Romer suggested recently that number could be significantly higher^3. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S.

While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter's SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

Additionally, Beckman Coulter's new assay is priced at $4 to all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing.

"While vaccines are coming, it will take time before everyone is able to receive their shot," said Shamiram R. Feinglass, M.D., M.P.H., chief medical officer for Beckman Coulter. "Until then, the only way to save lives is to mask, socially distance, test, trace and isolate. To test the masses and test them frequently, we need an affordable, reliable and scalable solution. Beckman Coulter is making this happen with a high-quality $4 COVID-19 test, so institutions and communities can implement, frequent mass COVID-19 testing that is easy to scale."

Beckman Coulter's new antigen test is appropriate for many of the same populations as RT-PCR tests—individuals who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments. According to the CDC, antigen tests can be used in high-risk settings, such as nursing homes, hospitals, universities and other group settings where repeat testing, coupled with relevant clinical information could identify COVID-19 infection to minimize transmission⁴. In addition, the FDA recently stated that it is now allowing antigen and molecular diagnostic tests to be used off-label in testing asymptomatic patients, as directed by a prescriber for prescription-use tests.

The Beckman Coulter antigen test can be a reliable alternative for laboratories to manage test demand and decrease their testing turnaround times. Moreover, while POC antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to address high-volume testing needs⁵.

Dr. Feinglass added, "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 larger populations; the workflow breaks down with too many manual steps in the process. Furthermore, a hospital must report positive results to regulatory bodies, and many POC tests require cumbersome manual recording of patient data into their EMR."

In contrast to the cumbersome workflow of POC antigen tests, the Beckman Coulter antigen test samples are collected with a nasopharyngeal swab at the point of care and can be stored at room temperature for up to 24 hours and refrigerated for 48 hours while transporting to the laboratory for processing. The ability to separate the sample collection from sample processing allows for flexibility to meet the needs of all Beckman Coulter customers from small laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.

Whether on a desktop or high-throughput analyzer, results are delivered electronically to physicians, patient portals and health agencies, allowing clinicians to initiate proper treatment, isolate patients, and start contact tracing, helping to minimize the spread of COVID-19.

Nicholas Decker, MLS (ASCP) laboratory director at Memorial Healthcare, "RT-PCR is a great tool; however, it is not one-size fits all. Affordable antigen testing is battle tested and has the ability to turn a laboratory into a well-rounded partner for our providers and patients."

Beckman Coulter is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and can immediately begin shipping 18 million tests per month, and ramp to 25 million tests per month by March 2021 to its customer base throughout the U.S. and Puerto Rico under Policy C. The test will be made available to markets accepting the CE Mark in January 2021.

To learn more about the $4 Access SARS-CoV-2 Antigen assay including how to place an order, or for the latest information on Beckman Coulter's response to COVID-19, visit www.beckmancoulter.com/antigenassay.

About Beckman Coulter's Suite of COVID-19 Testing Solutions
Beckman Coulter's suite of COVID-19 assays includes the $4 Access SAR-CoV-2 Antigen assay, as well as two qualitative antibody assays: Access SARS-CoV-2 IgM and Access SARS CoV-2 IgG assay, and a SARS-CoV-2 semi-quantitative IgG assay. The company also has an interleukin 6 (IL-6) assay, can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.

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, 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.

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. Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

Media Resources:
Beckman Coulter media kit

• Whiteboard video and other video assets
• B-Roll footage of Access SARS-CoV-2 Assays being shipped from Hebron, KY Beckman Coulter and lab footage
• Photos

References:

¹Based on a comparative of the Access SARS-CoV-2 Antigen assay to competitive Intended for Use (IFU) documents 
²https://www.rockefellerfoundation.org/national-covid-19-testing-action-plan/ [Accessed: December 10, 2020]
³https://www.nytimes.com/2020/03/23/opinion/coronavirus-depression.html [Accessed: December 10, 2020]
⁴https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html [Accessed: December 10, 2020]
⁵https://www.the-scientist.com/news-opinion/the-push-to-deploy-at-home-antigen-tests-for-covid-19-67831 [Accessed: December 10, 2020]

© 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.
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SOURCE Beckman Coulter Diagnostics

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