THREAD ON DIAGNOSTICS: In recent public health emergencies there’s been a stepwise approach to ramp up U.S. testing capacity. CDC develops test early in outbreak, then pursuant to Emergency Use Authorization (EUA) from FDA CDC makes test available to network of public health labs
CDC can develop and refine the testing protocol and work with labs to expand testing capacity until commercial test kit manufacturers receive EUAs to make tests more widely available to large commercial and academic laboratories.
FDA regulates test kits but generally lab developed tests, which are designed and used in single lab, can be offered without FDA review. When HHS declares Public Health Emergency and issues declaration to support EUAs, labs must seek FDA authorization before launching new test.
This means labs need to seek an EUA from FDA before offering an LDT to diagnose the novel coronavirus.
In public health emergency, tests not only diagnose serious or life-threatening disease that’s not completely understood, but help guide analyses of disease progression and risks to public health. Precision matters. False negative results can have significant adverse consequences
That’s why the approach has been for FDA to review all of these tests under its EUA authorities, which is an efficient framework for making medical products available in these epidemics. It was established to respond to public health emergencies like epidemics of novel pathogens
But this set up doesn’t mean we can’t have labs offer tests to diagnose COVID-19. FDA can grant an EUA to a laboratory to run a coronavirus test at a single site, or can authorize a common protocol for multiple laboratories to collaborate.
Since FDA doesn’t usually review and authorize LDTs, the agency could make clear what the expectations are for labs who have the expertise and equipment to expand our testing capacity and capacity to offer screening.
FDA could adopt a tailored approach, recognizing the expertise of academic abs that develop and run highly complex and novel tests everyday, and address the expectations for test design, validation, and performance to help labs pursue EUAs.
For labs, FDA focuses on analytical validation and process controls for a reliable test that help guide clinical decision making and inform public health analyses in a COVID-19 outbreak. CDC could actively support this by making test controls and samples available for validation.
FDA and CDC working together have a very important role to play to protect public health in these circumstances -- and make sure that screening tools are accurate and reliable -- while enabling access to technology that can support diagnosis, treatment, and response.
It may take kit manufacturers several more weeks to obtain an EUA from FDA because kit production is a significant undertaking intended to supply multiple labs. It’s unclear when CDC will be able to help more public health labs stand up tests, but the hope is very soon.
FDA and CDC are critical to this work and always focused on this mission. Now, given the need for additional testing capacity in the US, FDA and CDC could implement an approach specifically aimed at helping labs like academic hospitals offer their own validated LDTs for #COVID19
