Scaling Back Up To Make Rapid Tests Even More Available

As we head into the winter months, we're continuing to deploy all of our resources to help meet skyrocketing test demand.

Scaling Back Up To Make Rapid Tests Even More Available
Diagnostics Testing | Nov. 12, 2021

More people than ever have turned to rapid testing in the past few months as the Delta variant became the dominant strain and the Centers for Disease Control and Prevention's (CDC) updated guidance reprioritized testing. Schools, businesses and families have begun to understand that convenient rapid testing is the critical companion tool to vaccines — and are seeking out tests at exponential rates.

That's why we've taken action to increase supply and bring fast and broadly available testing to the people and communities in the U.S. that need it most during this critical moment in the pandemic — especially as the weather changes and people head indoors, travel and gather for the holidays, and return to their pre-pandemic lifestyles.

BinaxNOW continues to be the No. 1 rapid antigen test in the U.S.1 We are ramping up our manufacturing capacity significantly and are now producing more than 50 million BinaxNOW tests per month at our U.S. manufacturing facilities — and we can scale even further.

In the past several weeks, we reopened our plant in Illinois, which was idled over the summer when demand for testing plummeted. And we are hiring additional workers at our facility in Maine to keep up with the demand. We're also adding new machines that automate parts of our manufacturing process. This surge in testing capacity means tens of millions more of our American-made BinaxNOW tests will be available in the coming weeks. That’s in addition to the tens of millions of easy-to-use tests we shipped in recent months.

As we step-up manufacturing and distribute additional supply in the coming weeks, we continue to closely monitor our supply chain to remain as responsive as we’ve always been to our diverse customer base. We remain nimble so we can get tests into the community through our retail partners, while also supporting the government in bringing tests to the places where they’re needed most — including nursing homes, underserved communities, disaster areas, shelters and more.

We want to help people quarantine only when necessary and keep places open where they're gathering. This will be even more important in the months ahead, especially as the pandemic transitions to become more endemic, breakthrough infections continue to occur, the seasonality of the disease becomes more broadly understood, and flu makes a comeback.

With decades of experience in tracking viruses like HIV — including developing the first HIV test more than 35 years ago — we quickly understood the important role testing needed to play when COVID-19 first hit. We self-invested in our U.S. operations to stand up two high-quality manufacturing facilities in a 90-day span in 2020.

That's why, since the onset of this pandemic, no company has made as many user-friendly tests — as affordably and as readily accessible — as we have.

We have always worked in the best interests of public health through this pandemic and will continue to do so with an unrelenting focus on helping people know their COVID-19 status with the country's No. 1 rapid test.

 

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References
1Nielsen data.

 

 

EMERGENCY USE AUTHORIZATIONS

BinaxNOW™

The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.

 

The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.

 

This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. 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 moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

 

The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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