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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.

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 (6800/8800)2 EUA Preparing submission3
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 EUA4 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. cobas SARS-CoV-2 & Influenza A/B for 68/8800 will include improved influenza A assay.

  4. The current cobas SARS-CoV-2 EUA is not available on the cobas 5800.

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 De Novo 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

Yes, the PHE Declaration and the EUA declaration are separate. While the PHE ended May 11, 2023, and end date for the EUA Declaration has not yet been determined and communicated by the FDA. When the FDA announces the EUA termination date, labs should work with their manufacturer to understand the the path forward for each test they are utilizing.

The FDA has not announced when the EUA Declaration will be terminated. 

 

 

Roche is fully committed to transitioning our EUA portfolio to IVD regulatory status to support testing across the continuum of care. The work has already begun, with two tests already receiving 510(k) clearance (cobas® 6800/8800 SARS-CoV-2 Qualitative and cobas® liat SARS-CoV-2 & Flu A/B). 

While we do not have a definitive timeline for receiving clearance or approval, Roche is working expeditiously to submit the COVID-19 products that are currently on the market under an EUA to the FDA. 

 

The cobas liat SARS-CoV-2 assays were submitted for dual FDA 510(k) clearance to allow for the simultaneous 510(k) and CLIA waiver.

 

Reimbursement codes and amounts are staying the same for existing EUA multiplex tests like cobas SARS-CoV-2 & Influenza A/B tests and ePlex RP2 panel. However, there are reimbursement changes for standalone, high-throughput SARS-CoV-2 tests.

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.