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Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States

  • Rapid test to support the American public’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies and retailers nationwide
  • The COVID-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.
  • EUA granted through Roche’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program to bring rapid tests to the OTC market

 

INDIANAPOLIS, 24 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test.¹ The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old.² The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.

The FDA’s EUA decision stems from Roche’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP), which aims to accelerate the regulatory review and availability of high-quality, accurate and reliable OTC tests to the American public. The COVID-19 At-Home Test was prioritised by the FDA based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and ramp up manufacturing to meet future demands.

Starting in January, the COVID-19 At-Home Test will be available across the United States and in accordance with local guidelines and testing strategies. At the time of launch, Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response. The COVID-19 At-Home Test offers a convenient frequent testing option without the need to visit a healthcare provider.

“The COVID-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities,” said Thomas Schinecker, CEO, Roche Diagnostics. “At this inflection point in the American public’s fight against COVID-19, we are proud to have worked in close collaboration with the US Government to introduce and expand access to accurate, reliable and high-quality at-home tests.”

"Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response,” said Matt Sause, President & CEO of Roche Diagnostics North America. “As long as there remains a need for reliable testing, Roche will continue to invest in effective solutions to ensure there are testing options available to those who need them.”

Together with the COVID-19 At-Home Test, Roche will offer NAVIFY® Pass as a solution to organizations who want to allow individuals and health care professionals to remotely and securely store, display, and share results. All COVID-19 At-Home Tests are supplied with a unique data matrix, enabling NAVIFY® Pass to automatically link individuals’ test results to their respective test devices.

The launch will be in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched a range of tests throughout 2020 and 2021 in countries outside of the U.S. that accept the CE Mark, including the SARS-CoV-2 Rapid Antigen Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal, SARS-CoV-2 Rapid Antibody Test and SARS-CoV-2 & Flu A/B Rapid Antigen Test3. The test becomes the first rapid antigen test for SARS-CoV-2 from Roche to receive FDA Emergency Use Authorization, and the sixth rapid test overall to accompany Roche’s comprehensive portfolio of diagnostic solutions to help healthcare systems across the globe combat the COVID-19 pandemic through laboratory testing and at the point of care. Roche Diagnostics’ portfolio includes a wide range of molecular, rapid serological and digital solutions that help diagnose and manage COVID-19 during the initial stages of infections, during the recovery phase, and following the resolution of infection.

 

About the COVID-19 At-Home Test2

 

The COVID-19 At-Home Test is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in anterior nasal swab samples. In a prospective clinical study, the COVID-19 At-Home Test showed a relative sensitivity of 95.3% (95% CI: 84.5 to 98.7%) and a relative specificity of 100% (95% CI: 95.7 to 100%). Overall the studies included 138 symptomatic individuals (128 evaluable samples).² This test is intended for*: 1) Non-prescription home use (OTC) within the first 6 days of symptom onset; 2) Non-prescription home use with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

*Individuals aged 14 years or older can sample and test themselves. Children below the age of 14 must be sampled and tested by an adult.

The currently available sequences of variants of concern, including the Omicron variant SARS-CoV-2 (B.1.1.529), have been analysed and we can confirm that there is no impact on the performance of the test.

 

About antigen testing

 

An antigen test detects proteins that are structural or functional components of a pathogen and are thus very specific to that pathogen.1 In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes.2

In general, antigen tests have a high specificity, though are not as sensitive as molecular tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analyzed together with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results to help guide the diagnosis and subsequent treatment of the patient.

 

About Roche’s response to the COVID-19 pandemic

 

To address the global COVID-19 healthcare crisis, Roche has launched a growing number of diagnostic solutions that help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems. Roche also continues to identify, develop and support potential therapies that can play a role in treating the disease.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Roche continues to work with healthcare providers, laboratories, authorities and organizations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times.

The Roche portfolio of COVID-19 solutions includes:

  • cobas® SARS-CoV-2 Test - a high-volume molecular test to detect the virus that causes COVID- 19, (FDA Emergency Use Authorization (EUA) and available in countries accepting the CE Mark)
  • Elecsys® Anti-SARS-CoV-2 Test - a laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid protein (FDA EUA and CE Mark)
  • Elecsys® IL-6 - an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)
  • cobas® SARS-CoV-2 & Influenza A/B Test - a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
  • Elecsys® Anti-SARS-CoV-2 S Test - a second antibody test, aimed at measuring antibody response to the spike protein, to help assess a patient’s immune response and support the development of convalescent plasma therapy (FDA EUA and CE Mark)
  • SARS-CoV-2 & Influenza A/B Test for cobas® Liat System - a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)

 

About SD Biosensor

 

SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin, and cholesterols globally, and with innovative products, are striving to become a leading global in vitro diagnostic company.

 

About Roche

 

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life- saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
 
  1. This product has not been FDA cleared or approved, but has been authorized by the FDA under an EUA for non-prescription home use (OTC) with self- and adult-collected anterior nasal swab samples. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens;

    The emergency use of this product is 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.
  2. SD Biosensor. (2021). COVID-19 At-Home Test package insert.
  3. CE Mark obtained on 21 December 2021 for the SARS-CoV-2 & Flu A/B Rapid Antigen Test.

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