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When COVID-19’s spread slows, reopening the nation will depend on diagnostics

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Emerging from limitations imposed to prevent the spread of COVID-19 will depend on widely deploying rapid point-of-care diagnostics and complementary serological tests, according to a report from the American Enterprise Institute co-authored by former FDA commissioners Scott Gottlieb and Mark McClellan and three colleagues.

The authors outlined a road map comprising four phases for state and federal governments and their public health and healthcare partners to follow to navigate the pandemic response and eventually reopen the U.S. as the virus’ spread begins to slow.

Transitioning through the first three phases hinges on massive increases in testing capacity and diagnostic capabilities. Problems with the speed and capacity of diagnostics have plagued the U.S.’s response to the pandemic (see “Coronavirus Crisis Calls for Competence”).

Gottlieb is a resident fellow at the American Enterprise Institute and partner at New Enterprise Associates, while Mark McClellan is director of the Duke-Margolis Center for Health Policy. Lauren Silvis, an SVP at Tempus Inc. and former deputy director of FDA’s medical device center and chief of staff, and Johns Hopkins Center for Health Security assistant professors Caitlin Rivers and Crystal Watson also contributed to the report.

Some of the key goals in the first phase of the response, which is characterized by a growing number of new cases and widespread community transmission, include massively scaling up point-of-care diagnostic capacity, laying the groundwork for infection surveillance with serological testing and implementing a national surveillance system to compile the diagnostic data and track the virus.

The authors called for same-day, point-of-care diagnostics with a national capacity of at least 750,000 tests per week to move from community-based interventions to case-based ones in the second phase. FDA issued emergency use authorization (EUA) last week for three rapid point-of-care diagnostics for detection of active infection (“COVID-19 Crisis Spurs Innovation in Rapid Diagnostic Technologies”).

Transitioning from community-level physical distancing requirements, which can happen at the state or even local level, will require a sustained reduction in cases of at least 14 days, an increase in hospital capacity to care for critically ill patients and increased capacity for monitoring patients and close contacts.

The authors recommended ramping up production of personal protective equipment, nearly doubling the number of ventilators available and increasing capacity of critical care hospital beds from 2.8 per 10,000 people to at least 5-7. They also called for the use of fabric masks for the general public.

In the second phase, when some of the physical distancing tactics can be lifted and schools and businesses can begin to reopen, diagnostics that identify active infections will still play a critical role in identifying and monitoring patients and their contacts.

Serological tests that can determine whether a patient was previously exposed and is now presumably immune will come into the spotlight at this time. These tests may be able to identify people who can safely return to work, especially in front-line healthcare settings.

Unanswered questions about the potential for re-infection, the degree of the antibody response in patients with mild or asymptomatic infection and the required sensitivity of the tests still need to be resolved. The authors recommended appointing a task force involving senior leaders from various government agencies, academia and industry to oversee development of the tests.

No serological tests that detect antibodies to the virus rather than viral proteins have been authorized in the U.S., but they’re available in other countries.

Entering the third phase will require that vaccines or effective therapeutics are available, and serological surveillance will be important for prioritizing patients for vaccination during the ramp-up of manufacturing, and for assessing population-level immunity necessary for lifting all physical distancing requirements.

In the final phase, which involves building preparedness for future epidemics and national emergencies, the authors call for dedicated funding to develop flexible platforms for vaccines and other countermeasures that will allow for new drug and vaccine development in months instead of years.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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