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.
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.
