COVID-19

As the pandemic becomes an endemic, we remain committed to utilizing our medical and scientific knowledge to offer healthcare solutions and maintain vigilance.

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End of Public Health Emergency

Although the PHE has ended, the Food and Drug Administration (FDA) has not set a date as to when we must stop using products authorized under the COVID-19 Emergency Use Authorizations (EUAs). We are collaborating with the FDA to establish a complete regulatory process for our COVID-19 tests. Our main goal is to guarantee minimal interruptions during the EUA-to-FDA De Novo approval or 510(k) clearance transitions so that we can provide the appropriate test at the appropriate time, enabling the most effective treatment decisions.

We received FDA 510(k) clearance with CLIA waiver for the cobas® SARS-CoV-2 & Influenza A/B Assay.

cobas® SARS-CoV-2 & Influenza A/B assay receives FDA 510(k) clearance 

This is the first CLIA-waived, molecular point-of-care COVID-19 assay to transition from EUA to 510(k) clearance status.

Learn more

Product roadmap to IVD1

 

Our molecular COVID-19 diagnostic test status

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Our molecular COVID-19 diagnostic test status

Test
Current status
IVD status1
cobas® SARS-CoV-2 Qualitative (5800/6800/8800) US-IVD 510(k) clearance
cobas® SARS-CoV-2 & Flu A/B v2 (6800/8800)2 EUA N/a4
ePlex® RP22 EUA Preparing submission
cobas® SARS-CoV-2 Duo (6800/8800)2 EUA TBD
cobas® SARS-CoV-2 asymptomatic claim (5800/6800/8800)2 EUA3 Preparing submission
  1. In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
  2. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
  3. The current cobas SARS-CoV-2 EUA is not available on the cobas 5800.
  4. In Q4 2024, we are working toward a flexible multiplex respiratory viral panel designed to support testing for SARS-CoV-2, Influenza A/B and RSV and 9 additional targets. This product is currently in development and not available in the U.S.

Our core lab COVID-19 diagnostic test status

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Our core lab COVID-19 diagnostic test status

Test
Current status
IVD status1
Elecsys® Anti-SARS-CoV-2 (qualitative)2 EUA 510(k) submitted
Elecsys® Anti-SARS-CoV-2 S (semi-quant)2 EUA Preparing submission
Elecsys® IL-62 EUA Preparing submission
  1. In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
  2. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.

Our point of care COVID-19 diagnostic test status

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Our point of care COVID-19 diagnostic test status

Test
Current status
IVD status1
cobas® liat SARS-CoV-2 & Flu A/B US-IVD 510(k) clearance
cobas® liat SARS-CoV-22 EUA 510(k) application submitted Q4 2022
Pilot™ COVID-19 At-home Test2 (manufactured by SD Biosensor) EUA Preparing submission
  1. In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
  2. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
To learn more about Roche's COVID-19 portfolio, contact us.
Frequently asked questions

Frequently asked questions

We have a very broad solution for diagnostic testing among core lab, molecular lab, point of care, pathology lab, sequencing and more. As first to enable fully automated PCR on a high-throughput system, and now with our reinforced ability to quickly adapt to changes in market demands, we are well positioned to meet evolving healthcare needs across the continuum of care, now and in the future. 
– Whitney Green, senior vice president, molecular and pathology lab, Roche Diagnostics U.S.

Our response to the pandemic

In 1991, Roche developed the highly acclaimed polymerase chain reaction (PCR) method, which won a Nobel Prize. 

When the pandemic hit, we responded swiftly by creating a high-quality PCR SARS-CoV-2 test in just 42 days, the first commercial EUA granted by the FDA. As COVID-19 progressed, we expanded our diagnostic portfolio and developed 13 tests and solutions within 12 months. We focused on bringing testing closer to the patient by providing the first SARS-CoV-2 Real-time RT-PCR test, which yields results in just 20 minutes. We were able to achieve innovation through our collaboration with various organizations and groups, including Moderna and local communities. We remain dedicated to supporting COVID-19 diagnostics and monitoring emerging health threats even after the end of the Public Health Emergency, so that patients can have access to the necessary tests across the continuum of care.